Phase 3
Completed N=930
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Source: ClinicalTrials.gov NCT03545191 ↗Enrolled (actual)
930
Serious AEs
1.3%
Results posted
Mar 2022
Primary outcomePrimary: Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) — -18.40; -28.98; -6.20 minutes — p=<0.0001
◆ Published Evidence
Highly cited
228citations · ~57 / year
Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials.
Summary
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Linked Publications (5)
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Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials.
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The Effects of Daridorexant on Patients With Comorbid Insomnia Disorder and Untreated Mild Obstructive Sleep Apnoea: A Post Hoc Subgroup Analysis of a Phase 3, Randomised Clinical Trial.
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The Insomnia EEG Score: a new tool for the classification of people with poor sleep.
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Effect of daridorexant on nighttime wakefulness and next-morning sleepiness: assessing the transition from night to day in insomnia disorder.
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Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) |
-18.40; -28.98; -6.20 | <0.0001 sig |
| PRIMARY Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) |
-22.97; -29.41; -11.11 | <0.0001 sig |
| PRIMARY Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) |
-28.17; -31.20; -19.85 | 0.0005 sig |
| PRIMARY Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) |
-30.73; -34.80; -23.13 | 0.0015 sig |
| SECONDARY Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST) |
34.18; 43.62; 21.56 | = 0.0013 sig |
| SECONDARY Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST) |
47.83; 57.67; 37.90 | = 0.0334 sig |
| SECONDARY Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score |
-2.77; -3.77; -2.02 | = 0.0547 |
| SECONDARY Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score |
-4.78; -5.70; -3.79 | 0.0534 |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to any study-mandated procedure;
- Male or female aged ≥ 18 years;
- Insomnia disorder according to DSM-5 criteria;
- Insomnia Severity Index score ≥ 15;
- Insufficient sleep quantity as collected subjectively in the sleep diary;
- Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.
Exclusion Criteria
- Body mass index below 18.5 or above 40.0 kg/m2;
- Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
- Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
- Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
- Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
- Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;
- For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
- History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Data sourced from ClinicalTrials.gov (NCT03545191) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.