A Phase 4 interventional study of Daridorexant and Placebo in Insomnia Disorder and Nocturia, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 16 sites in 3 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 4, Interventional, and Treatment
A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia
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 60 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Idorsia Pharmaceuticals Ltd. is the lead sponsor of 103 studies on the registry; 4 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 9 (31%) have results posted.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.
Drug: Daridorexant
Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.
Drug: Placebo
Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.
Change From Baseline to Week 4 in sTST
Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization. Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).
Time frame: From baseline to Week 4 per treatment period.
Change From Baseline to Week 4 in Number of Nocturnal Voids Assessed Using a Voiding Diary
The number of nocturnal voids is the total of all nocturnal voids reported by the subject in the voiding diary. Baseline is the mean value based on subject's voiding diary entries for number of nocturnal voids across 3 nights during the screening period. Week 4 is the mean value based on subject's voiding diary entries for number of nocturnal voids across the 3 nights immediately preceding the Week 4 visit of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).
Time frame: From baseline to Week 4 per treatment period.
16 sites in 3 countries (USA, Spain and Germany) screened 149 subjects, and 9 sites enrolled (i.e., randomized) at least one subject. Screening started on 18 January 2023 (first subject first visit) and the first subject was enrolled on 16 February 2023.
| Milestone | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
| Milestone | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg |
|---|---|---|
| Started | 30 | 30 |
| Completed | 28 | 30 |
| Not completed | 2 | 0 |
| Withdrew: Forbidden medication | 2 | 0 |
| Milestone | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg |
|---|---|---|
| Started | 28 | 30 |
| Completed | 26 | 29 |
| Not completed | 2 | 1 |
| Withdrew: Advice from primary care physician | 1 | 0 |
| Withdrew: Subject lost investigational product | 1 | 0 |
| Withdrew: Private reasons | 0 | 1 |
Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization. Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).
| minutes | Daridorexant 50 mg | Placebo |
|---|---|---|
| Change From Baseline to Week 4 in sTST | 56.6 (46.0 to 67.2) | 35.7 (25.0 to 46.4) |
The number of nocturnal voids is the total of all nocturnal voids reported by the subject in the voiding diary. Baseline is the mean value based on subject's voiding diary entries for number of nocturnal voids across 3 nights during the screening period. Week 4 is the mean value based on subject's voiding diary entries for number of nocturnal voids across the 3 nights immediately preceding the Week 4 visit of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).
| number of nocturnal voids | Daridorexant 50 mg | Placebo |
|---|---|---|
| Change From Baseline to Week 4 in Number of Nocturnal Voids Assessed Using a Voiding Diary | -1.6 ± 1.4 | -1.3 ± 1.3 |
Collected over Treatment-emergent adverse events from the 29-day (± 2 days) treatment periods are reported. Adverse events were considered treatment-emergent if the date of onset or worsening was from the first intake of study treatment up to 5 days after the end of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daridorexant 50 mg | 0/60 (0%) | 0/60 (0%) | 6/60 (10%) |
| Placebo | 0/58 (0%) | 0/58 (0%) | 2/58 (3.4%) |
| Event | Daridorexant 50 mg | Placebo |
|---|---|---|
| Dry mouthGastrointestinal disorders | 3/60 | 2/58 |
| FatigueGeneral disorders | 3/60 | 0/58 |
| Age, Continuous(years) | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg | Total |
|---|---|---|---|
| Median | 63 (55 to 81) | 63 (55 to 80) | 63 (55 to 81) |
| Sex: Female, Male(Participants) | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg | Total |
|---|---|---|---|
| Female | 12 | 17 | 29 |
| Male | 18 | 13 | 31 |
| Race (NIH/OMB)(Participants) | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 10 | 18 |
| White | 22 | 20 | 42 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg | Total |
|---|---|---|---|
| United States | 20 | 22 | 42 |
| Germany | 7 | 6 | 13 |
| Spain | 3 | 2 | 5 |
| Subjective total sleep time (sTST)(minutes) | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg | Total |
|---|---|---|---|
| Mean | 367.20 ± 58.60 | 353.17 ± 54.85 | 360.31 ± 56.72 |
| Number of nocturnal voids(Number of nocturnal voids) | Daridorexant 50 mg, Then Placebo | Placebo, Then Daridorexant 50 mg | Total |
|---|---|---|---|
| Mean | 3.74 ± 1.05 | 3.52 ± 0.89 | 3.63 ± 0.97 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2023 to primary completion in Apr 2024, 13 months.
Results were first posted in Apr 2025, 1 year after primary completion.
Of 58 phase 4 interventional studies under Sleep Initiation and Maintenance Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 55. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Daridorexant
Sleep Initiation and Maintenance Disorders →
Idorsia Pharmaceuticals Ltd. →