A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Key facts
- Where
- Brandon, Cincinnati, Huntersville, Lemon Grove, Little Rock, Pomona, Raleigh, Virginia Gardens, and Weston, United StatesSee the 9 sites
- Phase
- Phase 3
Where in United States
- Teradan Clinical trials LLCBrandon, United StatesNot yet recruiting
- CTI Clinical Research CenterCincinnati, United StatesNot yet recruiting
- Advanced Respiratory and Sleep Medicince LLCHuntersville, United StatesNot yet recruiting
- Synergy San DiegoLemon Grove, United StatesNot yet recruiting
- Preferred Research Partners, IncLittle Rock, United StatesNot yet recruiting
- Empire Clinical ResearchPomona, United StatesNot yet recruiting
- Eximia Research - NC, LLCRaleigh, United StatesNot yet recruiting
- Hope Research NetworkVirginia Gardens, United StatesTaking people
- Encore Medical Research, LLC - WestonWeston, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Idorsia Pharmaceuticals Ltd.
- Trial code
- NCT07843329EU 2026-525730-38-00
- Record updated
- 5 November 2026
- Original description
The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder.Read full original descriptionShow less
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy of Daridorexant on Nighttime Symptoms and Daytime Functioning in Adult and Elderly Participants With Insomnia Disorder
The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder.
The trial aims to find out whether daridorexant can help improve:
* how trial participants sleep at night, * how trial participants function the next day.
Researchers will compare daridorexant to a placebo (a look-alike inactive substance that contains no active medicine) to understand which effect daridorexant has on total sleep time and next-day functioning.
Enrolled participants will:
* Take daridorexant 50 mg or placebo once daily for approximately 3 months * Visit the clinic once every month during treatment for checkups and tests * Keep a sleep diary of the number of hours they sleep and how well they sleep * Complete a questionnaire every day about any symptoms of sleepiness during the day and any impact on physical and mental functioning such as energy levels, mood, or ability to concentrate or memorize.
Inclusion: Male or female participants aged ≥ 18 years at the time of signing the ICF; Insomnia disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders criteria including: Self-reported insufficient sleep quantity defined as subjective Total Sleep Time (TST) ≤ 6.5 hours during the night, associated with difficulties with sleep initiation or maintenance or early-morning awakenings, for at least 3 nights per week during a period of at least 3 months prior to screening visit; Insomnia Severity Index© score ≥ 15; Presence of insomnia symptoms (TST ≤ 6.5 hours for at least 3 valid nights recording, and average TST ≤ 6.5 hours over 7 nights) confirmed by objective measurements using a home electroencephalogram (EEG) device over a 7-night period during screening; Adequate opportunity for sleep (time in bed ≥ 7 hours for at least 3 valid recorded nights) confirmed by objective measurements obtained using the home EEG device during the 7-night assessment period specified in the inclusion criterion above.
Exclusion: Previous treatment with daridorexant or other dual orexin receptor antagonists at any time prior to Visit 1; Any lifetime history of breathing-related sleep disorder; Presence of an additional sleep-wake disorder; Acute or unstable (i.e., not adequately controlled for at least 1 month) psychiatric condition; Any suicidal ideation or history of suicide attempt, as assessed by Columbia Suicide Severity Rating Scale© (C-SSRS©), at Visit 1; Unstable medical condition, which, in the opinion of the investigator, could affect the participant's safety or interfere with the trial assessments; Body mass index < 18.5 or > 40.0 kg/m2; Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week.