An interventional study of S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate in Sleep Disturbances, sponsored by Bonafide Health. Completed at 1 site in United States. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Bonafide Health (part of Otsuka Holdings Co., Ltd.) · Not applicable, Interventional, and Treatment
This open-label study evaluated whether a daily dietary sleep supplement could improve sleep and related daytime functioning in menopausal women aged 40 to 65 with impaired sleep. Participants used the supplement for approximately 12 weeks, followed by a four-week period without the supplement to evaluate changes after discontinuation. Sleep, daytime functioning, product experience, safety, and tolerability were assessed throughout the study.
This was an open-label, single-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep disturbance, sleep-related parameters, cognitive function, and well-being in perimenopausal and postmenopausal women with impaired sleep. All participants received the investigational dietary supplement.
Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which medical history, sleep disturbance, and other study eligibility criteria were assessed. Eligible participants then entered a run-in period of approximately seven days, during which they completed daily electronic sleep diaries to establish baseline sleep patterns and familiarize themselves with study procedures. No study product was consumed during the run-in period.
After completion of the run-in phase, participants initiated the intervention period on Day 1 and self-administered the study product once daily through approximately Day 85. The study product was administered orally as two tablets approximately 60 minutes before bedtime. Participants continued supplementation for approximately 12 weeks through the End of Intervention visit.
Throughout the intervention period, participants completed daily electronic sleep diaries and periodic electronic questionnaires assessing changes in sleep disturbance, sleep quality, cognitive function, daytime functioning, and overall well-being. Assessments were conducted at baseline and at regular intervals throughout the intervention period according to the protocol-defined schedule of activities. Participant experience with the study product was also assessed during the study.
Following completion of the intervention period, participants discontinued the study product and entered a washout period from approximately Day 86 through Day 113. Participants continued completing study assessments during this period to characterize changes in sleep and related outcomes after supplementation ended. A washout questionnaire was administered at the End of Study visit to evaluate participants' perceptions of changes in sleep, mood, cognitive function, and overall experience following discontinuation of the study product.
All study visits and assessments were conducted remotely through virtual or telephone visits. Safety and tolerability were monitored throughout the study through participant self-report, daily diary reporting, and scheduled safety check-ins. Adverse events were collected and monitored in accordance with protocol-defined safety procedures.
Each participant's total duration of participation was approximately 18 to 19 weeks, including screening, the run-in period, approximately 12 weeks of supplementation, the post-intervention washout period, and end-of-study assessments. The study was designed to characterize the effects, safety, tolerability, and participant experience associated with longer-term use of a dietary sleep supplement and to evaluate changes after discontinuation in menopausal women experiencing impaired sleep.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 90 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Bonafide Health is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
First submitted after Bonafide Health became part of Otsuka Holdings Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received Bonafide Sleep orally as two tablets once daily approximately 60 minutes before bedtime from Day 1 through Day 85. After the intervention period, participants discontinued the study product and entered a washout period through Day 113.
Dietary Supplement: S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate
Drug page: S-Adenosylmethionine
A daily dietary sleep supplement taken once per day for 85 days.
Also known as: Bonafide Sleep
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form T-Score
Change from baseline in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-score. The PROMIS SD SF assesses self-reported perceptions of sleep, including difficulty getting to or staying asleep, sleep satisfaction, and overall sleep quality over the prior seven days.
Time frame: Baseline (Day 1) through Day 113 (±3 days)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form T-Score
Change from baseline in the Patient-Reported Outcomes Measurement Information System Cognitive Function Short Form (PROMIS CF SF) T-score. The PROMIS CF SF assesses perceived cognitive abilities in everyday activities, including memory, attention, and mental clarity.
Time frame: Baseline (Day 1) through Day 113 (±3 days)
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a validated patient-reported instrument assessing sleep quality and disturbances over a one-month period, including sleep duration, sleep latency, habitual sleep efficiency, sleep disturbances, and overall subjective sleep quality.
Time frame: Baseline (Day 1) through Day 113 (±3 days), assessed every 28 days
Change in Total Sleep Time (TST)
Change from run-in baseline in total nightly sleep duration, as recorded in daily morning sleep diaries.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep Disturbances
Change from run-in baseline in self-reported nighttime sleep disturbances, as recorded in daily morning sleep diaries.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Wake After Sleep Onset (WASO)
Change from run-in baseline in wake after sleep onset, representing time spent awake after initially falling asleep, as recorded in daily morning sleep diaries.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep-Onset Latency (SOL)
Change from run-in baseline in sleep-onset latency, defined as the amount of time required to fall asleep after attempting to sleep, as recorded in daily morning sleep diaries.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Daytime Sleepiness
Change from run-in baseline in participant-reported daytime sleepiness, as assessed through daily sleep diary responses.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep and Well-Being Complaints Questionnaire Responses
Change from baseline in participant-reported sleep and well-being complaints.
Time frame: Baseline (Day 1) through Day 113 (±3 days), assessed every 28 days
Change in Sleep Quality as Measured by a Visual Analog Scale (VAS)
Change from baseline in self-reported sleep quality measured using a visual analog scale (VAS). The VAS is used to assess the participant's subjective perception of sleep quality and symptom severity over time.
Time frame: Baseline (Day 1) through Day 113 (±3 days)
Change in Sleep Disturbances as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported frequency of sleep disturbances measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no sleep disturbances and peaceful sleep every night, while a score of 100 indicates constant sleep disturbances every night. Lower scores indicate fewer sleep disturbances.
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Wakefulness After Sleep Onset (WASO) as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported difficulty returning to sleep after awakening during the night, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no nighttime awakening, while a score of 100 indicates finding it very difficult or impossible to fall back asleep. Lower scores indicate better sleep maintenance.
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Morning Ease as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported difficulty leaving bed and beginning the day, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no difficulty, while a score of 100 indicates extreme difficulty that is nearly impossible to overcome. Lower scores indicate greater ease beginning the day.
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Morning Grogginess as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported morning grogginess measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no grogginess and feeling fully alert upon waking, while a score of 100 indicates intense morning grogginess with marked drowsiness and lethargy. Lower scores indicate less morning grogginess.
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Change in Daytime Sleepiness as Measured by a Visual Analog Scale (VAS)
Mean within-subject change from baseline in self-reported daytime sleepiness measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates feeling alert and energetic without daytime sleepiness, while a score of 100 indicates daytime sleepiness dominated by an overpowering urge to sleep or nap. Lower scores indicate less daytime sleepiness.
Time frame: Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days
Participant Experience With the Study Product
Participant responses to the Product Experience Questionnaire assessing overall satisfaction with the study product, ease of use, perceived effects on sleep and daytime functioning, overall product experience, and willingness to recommend or continue using the product. Scored Likert items range from 1 (Strongly Disagree) to 4 (Strongly Agree), with higher scores indicating a more favorable product experience. Selected items include 0 = Not Applicable, which is not treated as a scored response. Additional items use Yes/No/Not Applicable or open-text responses. No composite total score is calculated; responses are summarized by individual item.
Time frame: Week 12 (Day 85 ± 3 days) and Week 16 (Day 113 ± 3 days)
Participant-Reported Changes Following Study Product Discontinuation
Participant responses to the Washout Questionnaire assessing perceived changes following discontinuation of the study product, including sleep quality, daytime restfulness and energy, cognitive function, mood, overall satisfaction, perceived product benefit, and likelihood of recommending the product. The questionnaire uses item-specific ordered categorical response options, including 4-level responses (e.g., Very Dissatisfied to Very Satisfied; Strongly Disagree to Strongly Agree) and 5-level responses (e.g., Not Effective to Very Effective; Much Worse to Much Better; Definitely Not to Definitely Yes). More favorable response categories indicate a more favorable perceived outcome. No composite total score or single minimum/maximum questionnaire score is calculated; responses are summarized by individual item.
Time frame: Week 16 (Day 113 ±3), following approximately 4 weeks of study product discontinuation
Change in Total Wake Time (TWT)
Change from run-in baseline in total time spent awake during the nighttime sleep period, as recorded or derived from daily morning sleep diary data.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Sleep Efficiency (SE)
Change from run-in baseline in sleep efficiency derived from participant-reported nighttime sleep data collected in daily morning sleep diaries.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Self-Reported Cognitive Function From Daily Sleep Diaries
Change from run-in baseline in participant-reported cognitive functioning and mental clarity, as assessed through daily sleep diary responses.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
Change in Self-Reported Alertness
Change from run-in baseline in participant-reported alertness during waking hours, as assessed through daily sleep diary responses.
Time frame: Day -7 (run-in baseline) through Day 113 (±3 days)
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Studies of the drug tested here: S-Adenosylmethionine
Sleep Initiation and Maintenance Disorders →