A Phase 2 interventional study of Lemborexant 2.5 mg and Lemborexant 5 mg in Irregular Sleep-Wake Rhythm Disorder, sponsored by Eisai Inc.. Completed at 48 sites in 3 countries. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-05-17.
Sponsored by Eisai Inc. · Phase 2, Interventional, and Treatment
This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters. Following the eligibility screening period, eligible participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks. After a 2-week follow-up period, eligible participants may enter an open-label extension period for up to 30 months or until the program discontinuation.
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Inclusion Criteria (Core Study):
Inclusion Criteria (Extension Phase):
Inclusion Criteria for Caregivers:
Exclusion Criteria:
Participants will take one lemborexant 2.5 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
Drug: Lemborexant 2.5 mg · Drug: Lemborexant-matched placebo
Participants will take one lemborexant 5 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
Drug: Lemborexant 5 mg · Drug: Lemborexant-matched placebo
Participants will take one lemborexant 10 mg tablet and one lemborexant-matched placebo tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
Drug: Lemborexant 10 mg · Drug: Lemborexant-matched placebo
Participants will take one lemborexant 5 mg tablet and one lemborexant 10 mg tablet orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
Drug: Lemborexant 10 mg · Drug: Lemborexant 15 mg
Participants will take two lemborexant-matched placebo tablets orally each night for 28 consecutive nights immediately (i.e., within 5 minutes) before the time the participant intends to try to sleep.
Drug: Lemborexant-matched placebo
Lemborexant 2.5 mg tablets
Lemborexant 5 mg tablets
Lemborexant 10 mg tablets
Lemborexant 5 mg and 10 mg tablets
Lemborexant-matched placebo tablets
Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment
The SFI was defined as the sum of a movement index (MI) and a fragmentation index (FI) during the logged sleep period. The MI was equal to the epochs of wake per time in bed (TBI) multiplied by 100. The FI was equal to the number of less than or equal to (\<=) 1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (%) (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in Mean SFI During Week 2 of Treatment
The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in Mean SFI During Week 3 of Treatment
The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in Mean SFI During Week 4 of Treatment
The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment
aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in the aMeanDurWB During Week 2 of Treatment
aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in the aMeanDurWB During Week 3 of Treatment
aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in the aMeanDurWB During Week 4 of Treatment
aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in Mean Actigraphy Wake Efficiency (aWE) During Week 1 of Treatment
aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in Mean aWE During Week 2 of Treatment
aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in Mean aWE During Week 3 of Treatment
aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in Mean aWE During Week 4 of Treatment
aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in Mean Wake Fragmentation Index (WFI) During Week 1 of Treatment
The WFI were calculated as the sum of an immobility index (II) and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of \<=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in Mean WFI During Week 2 of Treatment
The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of \<=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in Mean WFI During Week 3 of Treatment
The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of \<=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in Mean WFI During Week 4 of Treatment
The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of \<=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in the Mean Duration of Sleep Bouts (aMeanDurSB) During Week 1 of Treatment
aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in the aMeanDurSB During Week 2 of Treatment
aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in the aMeanDurSB During Week 3 of Treatment
aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in the aMeanDurSB During Week 4 of Treatment
aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 1 of Treatment
Intradaily variability gives an indication of irregular sleep-wake rhythm disorder (ISWRD) by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 2 of Treatment
Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 3 of Treatment
Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in Mean Intradaily Variability Over Week 4 of Treatment
Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in Mean Interdaily Stability (IS) Over Week 1 of Treatment
IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in Mean IS Over Week 2 of Treatment
IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in Mean IS Over Week 3 of Treatment
IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in Mean IS Over Week 4 of Treatment
IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in Average Activity Counts Across Least Active 5-hour Period (L5) Per 24-Hour Period Over Week 1 of Treatment
L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 2 of Treatment
L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 3 of Treatment
L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 4 of Treatment
L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in the Average Activity Count During the Most Active 10-hour Period (M10) Per 24-Hour Period Over Week 1 of Treatment
M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 2 of Treatment
M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 3 of Treatment
M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 4 of Treatment
M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in Amplitude of the Rest-activity Rhythm (AMP) Over Week 1 of Treatment
AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in AMP Over Week 2 of Treatment
AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in AMP Over Week 3 of Treatment
AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in AMP Over Week 4 of Treatment
AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Core Phase: Change From Baseline in Relative Amplitude in the Rest-activity Rhythm (RA) Over Week 1 of Treatment
RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
Time frame: Baseline, Week 1
Core Phase: Change From Baseline in RA Over Week 2 of Treatment
RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
Time frame: Baseline, Week 2
Core Phase: Change From Baseline in RA Over Week 3 of Treatment
RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
Time frame: Baseline, Week 3
Core Phase: Change From Baseline in RA Over Week 4 of Treatment
RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
Time frame: Baseline, Week 4
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: First dose of study drug (Day 1) to 14 days after last dose of study drug (approximately up to 2 years 7 months)
Core Phase: Number of Participants in Each Category With Clinician's Global Impression of Change-Irregular Sleep-Wake Rhythm Disorder (CGIC-ISWRD) Global Score at Day 29
The CGIC-ISWRD scale is a validated categorical measure of change in the participant's clinical condition between baseline and follow-up visits. It relies on both direct examination of the participant and an interview of the informant. The instrument consisted of 3 parts: a guided baseline interview administered to the participant and an informant, a follow-up interview administered to the participant and an informant, and a clinician's rating review. The baseline interview served as a reference for future ratings. During the baseline interview, the rater evaluated participant regarding domains of (1) sleep and wake symptoms; (2) mood and behavioral symptoms; (3) attention/arousal; and (4) social functioning. In the follow-up interview, a 7-pointscale was used, from 1 = marked improvement, 4 = no change, to 7 = marked worsening, to score each of the 4 domains and to provide a global score (1 \[marked improvement\] to 7 \[marked worsening\]).
Time frame: Day 29
Core Phase: Change From Baseline in the Neuropsychiatric Inventory (NPI-10) Total Score at Day 29
The NPI-10 assessed a wide range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was summarized and analyzed. This scale was administered with the caregiver as proxy for the participant. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently) \* Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score participant could get.
Time frame: Baseline, Day 29
Core Phase: Change From Baseline in the Sleep Disorders Inventory (SDI) Score at Day 29
The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 \[worst\]).
Time frame: Baseline, Day 29
Extension Phase: Change From Baseline in SDI Total Score.
The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 \[worst\]).
Time frame: Baseline, Day 133, 223, 313, 343, 373, 403, 493, 583, 673, and 763
Participants took part in the study at 57 investigative sites in the United States, Japan and United Kingdom from 20 Dec 2016 to 17 Apr 2020.
| Milestone | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Extension Phase: Lemborexant 5 mg | Extension Phase: Lemborexant 10 mg | Extension Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|---|---|---|
| Started | 12 | 12 | 14 | 13 | 12 | 0 | 0 | 0 |
| Treated | 12 | 12 | 13 | 13 | 12 | 0 | 0 | 0 |
| Completed | 12 | 12 | 13 | 13 | 12 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Randomized but not treated | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Extension Phase: Lemborexant 5 mg | Extension Phase: Lemborexant 10 mg | Extension Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 5 | 14 | 6 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 5 | 14 | 6 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 1 | 5 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
| Withdrew: Administrative reason | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 3 |
| Withdrew: Loss of caregiver | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Others | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 |
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| percentage of sleep time | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 76.34 ± 6.559 | 77.64 ± 7.883 | 78.45 ± 6.844 | 76.38 ± 8.037 | 77.35 ± 8.624 |
| Change at Week 1 | 0.14 ± 5.766 | 2.43 ± 3.910 | 3.87 ± 4.646 | -0.17 ± 5.861 | 0.05 ± 4.475 |
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| percentage of sleep time | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 76.34 ± 6.559 | 77.64 ± 7.883 | 78.45 ± 6.844 | 76.38 ± 8.037 | 77.35 ± 8.624 |
| Change at Week 2 | -1.31 ± 7.004 | 2.17 ± 2.833 | 1.65 ± 4.644 | -1.41 ± 5.896 | -0.07 ± 5.449 |
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| percentage of sleep time | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 76.34 ± 6.559 | 77.64 ± 7.883 | 78.45 ± 6.844 | 76.38 ± 8.037 | 77.35 ± 8.624 |
| Change at Week 3 | -0.30 ± 10.552 | 1.68 ± 3.229 | 0.91 ± 7.571 | -1.49 ± 4.442 | 1.10 ± 7.112 |
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| percentage of sleep time | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 76.34 ± 6.559 | 77.64 ± 7.883 | 78.45 ± 6.844 | 76.38 ± 8.037 | 77.35 ± 8.624 |
| Change at Week 4 | -0.78 ± 9.555 | 1.68 ± 4.696 | 0.00 ± 5.547 | -1.04 ± 5.920 | -0.81 ± 7.735 |
The SFI was defined as the sum of a movement index (MI) and a fragmentation index (FI) during the logged sleep period. The MI was equal to the epochs of wake per time in bed (TBI) multiplied by 100. The FI was equal to the number of less than or equal to (\<=) 1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (%) (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| percentage of immobile bouts | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 58.51 ± 12.923 | 53.87 ± 17.594 | 50.07 ± 12.493 | 54.75 ± 16.380 | 54.78 ± 15.338 |
| Change at Week 1 | -1.43 ± 9.294 | -5.80 ± 11.388 | -8.16 ± 8.802 | -2.55 ± 11.756 | -3.52 ± 8.882 |
The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| percentage of immobile bouts | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 58.51 ± 12.923 | 53.87 ± 17.594 | 50.07 ± 12.493 | 54.75 ± 16.380 | 54.78 ± 15.338 |
| Change at Week 2 | 2.52 ± 11.845 | -6.91 ± 5.994 | -4.95 ± 8.399 | 0.34 ± 14.194 | -3.18 ± 8.971 |
The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| percentage of immobile bouts | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 58.51 ± 12.923 | 53.87 ± 17.594 | 50.07 ± 12.493 | 54.75 ± 16.380 | 54.78 ± 15.338 |
| Change at Week 3 | -3.30 ± 18.512 | -2.79 ± 7.541 | -5.22 ± 11.974 | 0.36 ± 9.018 | -4.92 ± 9.572 |
The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number \<=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| percentage of immobile bouts | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 58.51 ± 12.923 | 53.87 ± 17.594 | 50.07 ± 12.493 | 54.75 ± 16.380 | 54.78 ± 15.338 |
| Change at Week 4 | -1.39 ± 19.383 | -1.35 ± 8.821 | -1.96 ± 8.459 | -0.45 ± 13.389 | -1.68 ± 12.683 |
aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| minutes | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 20.32 ± 6.625 | 20.40 ± 5.140 | 20.62 ± 5.898 | 21.89 ± 4.885 | 21.94 ± 7.790 |
| Change at Week 1 | -1.65 ± 5.078 | -1.99 ± 2.825 | -0.51 ± 6.522 | -0.82 ± 5.722 | 1.54 ± 5.378 |
aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| minutes | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 20.32 ± 6.625 | 20.40 ± 5.140 | 20.62 ± 5.898 | 21.89 ± 4.885 | 21.94 ± 7.790 |
| Change at Week 2 | -0.32 ± 7.904 | 1.79 ± 12.957 | 4.71 ± 13.845 | 1.54 ± 6.333 | 2.57 ± 6.708 |
aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| minutes | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 20.32 ± 6.625 | 20.40 ± 5.140 | 20.62 ± 5.898 | 21.89 ± 4.885 | 21.94 ± 7.790 |
| Change at Week 3 | -2.88 ± 7.928 | 3.67 ± 7.833 | -0.52 ± 4.595 | -0.64 ± 5.482 | 2.76 ± 7.489 |
aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| minutes | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 20.32 ± 6.625 | 20.40 ± 5.140 | 20.62 ± 5.898 | 21.89 ± 4.885 | 21.94 ± 7.790 |
| Change at Week 4 | -1.26 ± 8.621 | -0.43 ± 8.053 | 3.16 ± 8.140 | -2.03 ± 4.947 | 3.38 ± 12.354 |
aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| percentage of wake time | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 69.74 ± 12.609 | 70.57 ± 11.669 | 72.53 ± 11.473 | 67.19 ± 11.523 | 70.67 ± 11.221 |
| Change at Week 1 | 0.59 ± 4.177 | -2.41 ± 6.726 | 1.09 ± 6.793 | -1.55 ± 9.216 | -2.37 ± 8.779 |
aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| percentage of wake time | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 69.74 ± 12.609 | 70.57 ± 11.669 | 72.53 ± 11.473 | 67.19 ± 11.523 | 70.67 ± 11.221 |
| Change at Week 2 | 2.14 ± 2.773 | -1.54 ± 6.550 | 1.04 ± 7.511 | -3.16 ± 12.816 | -0.63 ± 5.617 |
aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| percentage of wake time | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 69.74 ± 12.609 | 70.57 ± 11.669 | 72.53 ± 11.473 | 67.19 ± 11.523 | 70.67 ± 11.221 |
| Change at Week 3 | 1.64 ± 5.451 | -2.37 ± 6.239 | 2.34 ± 8.370 | -4.99 ± 11.479 | -1.83 ± 5.579 |
aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| percentage of wake time | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 69.74 ± 12.609 | 70.57 ± 11.669 | 72.53 ± 11.473 | 67.19 ± 11.523 | 70.67 ± 11.221 |
| Change at Week 4 | 2.03 ± 6.841 | -2.29 ± 7.724 | 3.62 ± 8.586 | -2.65 ± 9.627 | -0.43 ± 5.848 |
The WFI were calculated as the sum of an immobility index (II) and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of \<=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| percentage of immobile bouts | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 92.43 ± 18.547 | 85.72 ± 16.137 | 86.53 ± 18.705 | 94.76 ± 17.262 | 87.96 ± 15.928 |
| Change at Week 1 | -0.14 ± 6.968 | 4.22 ± 9.988 | -2.18 ± 10.571 | 2.01 ± 13.017 | 3.25 ± 13.006 |
The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of \<=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| percentage of immobile bouts | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 92.43 ± 18.547 | 85.72 ± 16.137 | 86.53 ± 18.705 | 94.76 ± 17.262 | 87.96 ± 15.928 |
| Change at Week 2 | -3.76 ± 3.940 | 4.12 ± 8.671 | -2.36 ± 11.453 | 5.09 ± 19.006 | 1.78 ± 9.271 |
The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of \<=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| percentage of immobile bouts | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 92.43 ± 18.547 | 85.72 ± 16.137 | 86.53 ± 18.705 | 94.76 ± 17.262 | 87.96 ± 15.928 |
| Change at Week 3 | -1.65 ± 7.980 | 4.70 ± 9.674 | -3.69 ± 13.236 | 6.88 ± 16.704 | 2.10 ± 8.631 |
The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of \<=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100% (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| percentage of immobile bouts | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 92.43 ± 18.547 | 85.72 ± 16.137 | 86.53 ± 18.705 | 94.76 ± 17.262 | 87.96 ± 15.928 |
| Change at Week 4 | -3.01 ± 10.620 | 4.55 ± 10.930 | -6.93 ± 14.428 | 2.77 ± 13.407 | 1.22 ± 8.054 |
aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| minutes | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 18.36 ± 4.620 | 20.65 ± 3.638 | 23.13 ± 5.919 | 19.84 ± 3.364 | 23.30 ± 10.862 |
| Change at Week 1 | 2.15 ± 2.539 | 0.09 ± 4.056 | -1.12 ± 5.202 | -0.40 ± 3.394 | -3.19 ± 10.405 |
aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| minutes | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 18.36 ± 4.620 | 20.65 ± 3.638 | 23.13 ± 5.919 | 19.84 ± 3.364 | 23.30 ± 10.862 |
| Change at Week 2 | 0.25 ± 2.999 | -0.88 ± 4.679 | -2.52 ± 5.965 | -0.80 ± 2.961 | -3.95 ± 8.980 |
aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| minutes | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 18.36 ± 4.620 | 20.65 ± 3.638 | 23.13 ± 5.919 | 19.84 ± 3.364 | 23.30 ± 10.862 |
| Change at Week 3 | -0.14 ± 3.249 | -1.17 ± 4.056 | -3.80 ± 3.701 | -0.68 ± 2.292 | -4.15 ± 10.264 |
aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. Lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| minutes | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 18.36 ± 4.620 | 20.65 ± 3.638 | 23.13 ± 5.919 | 19.84 ± 3.364 | 23.30 ± 10.862 |
| Change at Week 4 | 1.00 ± 4.568 | -1.31 ± 3.639 | -2.80 ± 5.727 | -0.03 ± 2.307 | -5.30 ± 9.745 |
Intradaily variability gives an indication of irregular sleep-wake rhythm disorder (ISWRD) by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 1.10 ± 0.262 | 0.90 ± 0.272 | 0.98 ± 0.295 | 1.10 ± 0.295 | 1.03 ± 0.330 |
| Change at Week 1 | -0.01 ± 0.200 | 0.06 ± 0.218 | -0.03 ± 0.237 | 0.10 ± 0.271 | -0.01 ± 0.278 |
Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 1.10 ± 0.262 | 0.90 ± 0.272 | 0.98 ± 0.295 | 1.10 ± 0.295 | 1.03 ± 0.330 |
| Change at Week 2 | -0.05 ± 0.132 | 0.14 ± 0.325 | 0.02 ± 0.235 | 0.07 ± 0.143 | 0.05 ± 0.234 |
Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 1.10 ± 0.262 | 0.90 ± 0.272 | 0.98 ± 0.295 | 1.10 ± 0.295 | 1.03 ± 0.330 |
| Change at Week 3 | -0.06 ± 0.243 | 0.07 ± 0.246 | -0.00 ± 0.241 | -0.06 ± 0.311 | -0.01 ± 0.219 |
Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 1.10 ± 0.262 | 0.90 ± 0.272 | 0.98 ± 0.295 | 1.10 ± 0.295 | 1.03 ± 0.330 |
| Change at Week 4 | -0.10 ± 0.324 | 0.10 ± 0.196 | 0.02 ± 0.157 | -0.12 ± 0.274 | -0.10 ± 0.222 |
IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.45 ± 0.173 | 0.47 ± 0.111 | 0.49 ± 0.118 | 0.46 ± 0.160 | 0.41 ± 0.104 |
| Change at Week 1 | 0.04 ± 0.083 | -0.02 ± 0.089 | 0.04 ± 0.115 | -0.00 ± 0.155 | 0.06 ± 0.063 |
IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.45 ± 0.173 | 0.47 ± 0.111 | 0.49 ± 0.118 | 0.46 ± 0.160 | 0.41 ± 0.104 |
| Change at Week 2 | 0.06 ± 0.093 | -0.01 ± 0.101 | 0.03 ± 0.133 | -0.06 ± 0.091 | 0.09 ± 0.085 |
IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.45 ± 0.173 | 0.47 ± 0.111 | 0.49 ± 0.118 | 0.46 ± 0.160 | 0.41 ± 0.104 |
| Change at Week 3 | 0.03 ± 0.104 | -0.01 ± 0.107 | 0.03 ± 0.115 | -0.04 ± 0.136 | 0.04 ± 0.075 |
IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.45 ± 0.173 | 0.47 ± 0.111 | 0.49 ± 0.118 | 0.46 ± 0.160 | 0.41 ± 0.104 |
| Change at Week 4 | 0.02 ± 0.098 | 0.01 ± 0.119 | 0.08 ± 0.092 | 0.03 ± 0.127 | 0.00 ± 0.102 |
L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 1163.5 ± 373.3 | 1266.4 ± 678.1 | 1163.2 ± 591.8 | 1257.1 ± 836.6 | 1490.4 ± 963.1 |
| Change at Week 1 | 200.9 ± 633.3 | -259.8 ± 450.3 | -243.2 ± 333.6 | -211.6 ± 378.3 | -434.2 ± 509.1 |
L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 1163.5 ± 373.3 | 1266.4 ± 678.1 | 1163.2 ± 591.8 | 1257.1 ± 836.6 | 1490.4 ± 963.1 |
| Change at Week 2 | 85.8 ± 525.3 | -259.8 ± 244.9 | -218.7 ± 321.6 | 218.5 ± 455.9 | -246.1 ± 637.6 |
L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 1163.5 ± 373.3 | 1266.4 ± 678.1 | 1163.2 ± 591.8 | 1257.1 ± 836.6 | 1490.4 ± 963.1 |
| Change at Week 3 | 299.2 ± 1070.2 | -265.3 ± 507.0 | -233.0 ± 369.3 | -114.6 ± 376.6 | -396.1 ± 543.9 |
L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 1163.5 ± 373.3 | 1266.4 ± 678.1 | 1163.2 ± 591.8 | 1257.1 ± 836.6 | 1490.4 ± 963.1 |
| Change at Week 4 | 293.1 ± 662.6 | -334.0 ± 476.4 | -344.5 ± 419.1 | 30.5 ± 772.5 | -160.7 ± 471.3 |
M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 8560.4 ± 2631.2 | 11567.0 ± 4266.3 | 12158.1 ± 3639.9 | 10662.1 ± 5023.6 | 11460.5 ± 4954.3 |
| Change at Week 1 | 59.7 ± 1832.6 | -731.4 ± 3373.5 | 42.5 ± 1789.3 | -334.6 ± 2659.2 | -111.2 ± 2558.0 |
M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 8560.4 ± 2631.2 | 11567.0 ± 4266.3 | 12158.1 ± 3639.9 | 10662.1 ± 5023.6 | 11460.5 ± 4954.3 |
| Change at Week 2 | 232.7 ± 1829.1 | -968.8 ± 2885.6 | -121.1 ± 2137.3 | -564.2 ± 1975.7 | -325.4 ± 1585.4 |
M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 8560.4 ± 2631.2 | 11567.0 ± 4266.3 | 12158.1 ± 3639.9 | 10662.1 ± 5023.6 | 11460.5 ± 4954.3 |
| Change at Week 3 | 300.3 ± 2094.9 | -986.2 ± 3502.0 | 572.6 ± 2216.0 | -828.3 ± 1970.2 | -635.8 ± 2413.6 |
M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 8560.4 ± 2631.2 | 11567.0 ± 4266.3 | 12158.1 ± 3639.9 | 10662.1 ± 5023.6 | 11460.5 ± 4954.3 |
| Change at Week 4 | 1650.4 ± 1815.3 | -1392.1 ± 2249.3 | -477.4 ± 963.2 | 279.8 ± 2204.0 | -457.8 ± 1788.7 |
AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 7396.9 ± 2728.3 | 10300.6 ± 4235.8 | 10994.8 ± 3601.8 | 9405.0 ± 5133.9 | 9970.0 ± 4905.8 |
| Change at Week 1 | -141.1 ± 1583.8 | -471.6 ± 3414.4 | 285.8 ± 1788.6 | -123.0 ± 2784.1 | 323.0 ± 2436.0 |
AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 7396.9 ± 2728.3 | 10300.6 ± 4235.8 | 10994.8 ± 3601.8 | 9405.0 ± 5133.9 | 9970.0 ± 4905.8 |
| Change at Week 2 | 146.8 ± 1603.7 | -708.9 ± 2934.6 | 97.6 ± 2105.2 | -782.7 ± 2141.4 | -79.3 ± 1672.5 |
AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 7396.9 ± 2728.3 | 10300.6 ± 4235.8 | 10994.8 ± 3601.8 | 9405.0 ± 5133.9 | 9970.0 ± 4905.8 |
| Change at Week 3 | 1.1 ± 1862.7 | -721.0 ± 3502.2 | 805.6 ± 2195.6 | -713.7 ± 2178.3 | -239.7 ± 2592.5 |
AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| activity count | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 7396.9 ± 2728.3 | 10300.6 ± 4235.8 | 10994.8 ± 3601.8 | 9405.0 ± 5133.9 | 9970.0 ± 4905.8 |
| Change at Week 4 | 1357.3 ± 1801.9 | -1058.0 ± 2170.9 | -132.9 ± 840.7 | 249.4 ± 2694.7 | -297.1 ± 1608.2 |
RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.73 ± 0.136 | 0.79 ± 0.141 | 0.82 ± 0.089 | 0.77 ± 0.165 | 0.76 ± 0.148 |
| Change at Week 1 | -0.02 ± 0.101 | 0.01 ± 0.080 | 0.03 ± 0.067 | 0.02 ± 0.096 | 0.07 ± 0.073 |
RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.73 ± 0.136 | 0.79 ± 0.141 | 0.82 ± 0.089 | 0.77 ± 0.165 | 0.76 ± 0.148 |
| Change at Week 2 | -0.00 ± 0.073 | 0.01 ± 0.063 | 0.03 ± 0.052 | -0.05 ± 0.112 | 0.05 ± 0.091 |
RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.73 ± 0.136 | 0.79 ± 0.141 | 0.82 ± 0.089 | 0.77 ± 0.165 | 0.76 ± 0.148 |
| Change at Week 3 | -0.01 ± 0.143 | 0.01 ± 0.088 | 0.04 ± 0.063 | 0.01 ± 0.090 | 0.06 ± 0.080 |
RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.
| ratio | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.73 ± 0.136 | 0.79 ± 0.141 | 0.82 ± 0.089 | 0.77 ± 0.165 | 0.76 ± 0.148 |
| Change at Week 4 | -0.00 ± 0.117 | 0.01 ± 0.060 | 0.05 ± 0.049 | 0.01 ± 0.136 | 0.02 ± 0.069 |
| Participants | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Extension Phase: Lemborexant 5 mg | Extension Phase: Lemborexant 10 mg | Extension Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|---|---|---|
| TEAEs | 4 | 3 | 3 | 4 | 6 | 4 | 10 | 5 |
| SAEs | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 |
The CGIC-ISWRD scale is a validated categorical measure of change in the participant's clinical condition between baseline and follow-up visits. It relies on both direct examination of the participant and an interview of the informant. The instrument consisted of 3 parts: a guided baseline interview administered to the participant and an informant, a follow-up interview administered to the participant and an informant, and a clinician's rating review. The baseline interview served as a reference for future ratings. During the baseline interview, the rater evaluated participant regarding domains of (1) sleep and wake symptoms; (2) mood and behavioral symptoms; (3) attention/arousal; and (4) social functioning. In the follow-up interview, a 7-pointscale was used, from 1 = marked improvement, 4 = no change, to 7 = marked worsening, to score each of the 4 domains and to provide a global score (1 \[marked improvement\] to 7 \[marked worsening\]).
| Participants | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Global score: Marked improvement | 1 | 0 | 0 | 0 | 0 |
| Global score: Moderate improvement | 1 | 0 | 2 | 1 | 0 |
| Global score: Minimal improvement | 4 | 4 | 4 | 5 | 3 |
| Global score: No change | 6 | 5 | 4 | 3 | 7 |
| Global score: Minimal worsening | 0 | 3 | 2 | 3 | 1 |
| Global score : Moderate worsening | 0 | 0 | 0 | 0 | 0 |
| Global score : Marked worsening | 0 | 0 | 0 | 0 | 0 |
The NPI-10 assessed a wide range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was summarized and analyzed. This scale was administered with the caregiver as proxy for the participant. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently) \* Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score participant could get.
| score on a scale | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 3.8 ± 4.13 | 13.1 ± 17.77 | 7.7 ± 12.32 | 6.4 ± 10.27 | 5.5 ± 5.73 |
| Change at Day 29 | -2.8 ± 3.64 | -3.4 ± 9.23 | -0.3 ± 5.85 | -3.4 ± 8.95 | 3.8 ± 13.02 |
The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 \[worst\]).
| score on a scale | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|
| Baseline | 0.79 ± 0.692 | 1.24 ± 1.576 | 0.74 ± 0.653 | 0.66 ± 0.748 | 1.44 ± 1.708 |
| Change at Day 29 | -0.48 ± 1.078 | -0.10 ± 0.616 | -0.33 ± 0.503 | -0.09 ± 0.574 | -0.49 ± 1.220 |
The SDI is an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consists of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions is a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score is derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 \[worst\]).
| score on a scale | Extension Phase: Lemborexant 5 mg | Extension Phase: Lemborexant 10 mg | Extension Phase: Lemborexant 15 mg |
|---|---|---|---|
| Baseline | 1.36 ± 1.948 | 0.74 ± 0.728 | 1.45 ± 2.331 |
| Change at Day 133 (Visit 9) | 1.40 | -0.45 ± 0.600 | -0.63 ± 0.473 |
| Change at Day 223 (Visit 12) | — | -0.60 ± 0.693 | 0.17 ± 0.306 |
| Change at Day 313 (Visit 15) | — | -0.65 ± 0.574 | -0.17 ± 1.266 |
| Change at Day 343 (Visit 16) | 0.60 | 0.55 ± 1.061 | 0.45 ± 0.919 |
| Change at Day 373 (Visit 17) | — | -0.20 | — |
| Change at Day 403 (Visit 18) | — | -0.50 ± 0.539 | -0.55 ± 0.656 |
| Change at Day 493 (Visit 19) | — | -0.13 ± 0.115 | -0.10 |
| Change at Day 583 (Visit 20) | — | -0.15 ± 0.071 | -0.35 ± 0.354 |
| Change at Day 673 (Visit 21) | — | -0.30 | -0.15 ± 0.071 |
| Change at Day 763 (Visit 22) | — | -0.05 ± 0.354 | — |
Collected over First dose of study drug (Day 1) to 14 days after last dose of study drug (approximately up to 2 years 7 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Core Phase: Lemborexant-matched Placebo | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Core Phase: Lemborexant 2.5 mg | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Core Phase: Lemborexant 5 mg | 0/13 (0%) | 0/13 (0%) | 3/13 (23.1%) |
| Core Phase: Lemborexant 10 mg | 0/13 (0%) | 0/13 (0%) | 4/13 (30.8%) |
| Core Phase: Lemborexant 15 mg | 0/12 (0%) | 0/12 (0%) | 6/12 (50%) |
| Extension Phase: Lemborexant 5 mg | 0/5 (0%) | 1/5 (20%) | 4/5 (80%) |
| Extension Phase: Lemborexant 10 mg | 0/14 (0%) | 2/14 (14.3%) | 10/14 (71.4%) |
| Extension Phase: Lemborexant 15 mg | 0/6 (0%) | 1/6 (16.7%) | 5/6 (83.3%) |
| Event | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Extension Phase: Lemborexant 5 mg | Extension Phase: Lemborexant 10 mg | Extension Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|---|---|---|
| Ischaemic strokeNervous system disorders | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 1/5 | 0/14 | 0/6 |
| Ilium fractureInjury, poisoning and procedural complications | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 0/5 | 0/14 | 1/6 |
| AstheniaGeneral disorders | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 0/5 | 1/14 | 0/6 |
| HypercapniaRespiratory, thoracic and mediastinal disorders | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 0/5 | 1/14 | 0/6 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 0/5 | 1/14 | 0/6 |
| Orthostatic hypotensionVascular disorders | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 0/5 | 1/14 | 0/6 |
| Event | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Extension Phase: Lemborexant 5 mg | Extension Phase: Lemborexant 10 mg | Extension Phase: Lemborexant 15 mg |
|---|---|---|---|---|---|---|---|---|
| SomnolenceNervous system disorders | 0/12 | 0/12 | 0/13 | 1/13 | 2/12 | 3/5 | 0/14 | 0/6 |
| DiarrhoeaGastrointestinal disorders | 0/12 | 0/12 | 0/13 | 0/13 | 1/12 | 1/5 | 0/14 | 2/6 |
| NasopharyngitisInfections and infestations | 1/12 | 0/12 | 1/13 | 0/13 | 0/12 | 0/5 | 4/14 | 2/6 |
| DepressionPsychiatric disorders | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 0/5 | 3/14 | 0/6 |
| BradycardiaCardiac disorders | 0/12 | 0/12 | 0/13 | 0/13 | 1/12 | 1/5 | 0/14 | 0/6 |
| SedationNervous system disorders | 0/12 | 0/12 | 1/13 | 0/13 | 0/12 | 1/5 | 0/14 | 0/6 |
| ContusionInjury, poisoning and procedural complications | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 1/5 | 0/14 | 0/6 |
| FallInjury, poisoning and procedural complications | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 1/5 | 2/14 | 1/6 |
| Upper limb fractureInjury, poisoning and procedural complications | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 1/5 | 0/14 | 0/6 |
| OsteoporosisMusculoskeletal and connective tissue disorders | 0/12 | 0/12 | 0/13 | 0/13 | 0/12 | 1/5 | 0/14 | 0/6 |
The safety analysis set included the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose safety assessment.
| Age, Continuous(years) | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Total |
|---|---|---|---|---|---|---|
| Mean | 75.3 ± 6.15 | 76.5 ± 6.32 | 76.9 ± 7.98 | 71.8 ± 7.05 | 71.9 ± 6.11 | 74.5 ± 6.94 |
| Sex: Female, Male(Participants) | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Total |
|---|---|---|---|---|---|---|
| Female | 7 | 6 | 8 | 6 | 10 | 37 |
| Male | 5 | 6 | 5 | 7 | 2 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 4 | 6 | 8 | 24 |
| Not Hispanic or Latino | 8 | 10 | 9 | 7 | 4 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Core Phase: Lemborexant-matched Placebo | Core Phase: Lemborexant 2.5 mg | Core Phase: Lemborexant 5 mg | Core Phase: Lemborexant 10 mg | Core Phase: Lemborexant 15 mg | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 2 | 2 | 3 | 2 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 2 | 1 | 1 | 7 |
| White | 8 | 9 | 8 | 9 | 9 | 43 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 1 |
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