Can daridorexant help adults and older adults sleep better at night and feel better during the day?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares daily daridorexant 50 mg to placebo over about 3 months in adults with insomnia disorder. Participants will undergo monthly clinic visits, maintain a sleep diary, and complete daily symptom and functioning questionnaires to gauge effects on sleep and daytime performance. Eligibility requires adult participants with insomnia symptoms supported by both subjective reports and home EEG validation. The study includes a screening period, randomization in a 1:1 ratio, a treatment phase, a safety follow-up period of up to 10 days, and a final follow-up call, with participation lasting up to roughly 4 months. The trial is sponsored by Idorsia with sites in Arkansas and California.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Body mass index \< 18.5 or \> 40.0 kg/m2
* Any lifetime history of breathing-related sleep disorder
* Presence of an additional sleep-wake disorder
* Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week
* Previous treatment with daridorexant or other dual orexin receptor antagonists at any time prior to Visit 1
* 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

Where it's running

• Hope Research Network
  Virginia Gardens, Florida, United States Recruiting
• Preferred Research Partners Inc.
  Little Rock, Arkansas, United States Not yet recruiting
• Synergy San Diego
  Lemon Grove, California, United States Not yet recruiting
• Empire Clinical Research
  Pomona, California, United States Not yet recruiting
• Teradan Clinical Trials, LLC
  Brandon, Florida, United States Not yet recruiting
• Encore Medical Research, LLC - Weston
  Weston, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: Idorsia Clinical Trial Information USA
• Email: idorsiaclinicaltrials@idorsia.com
• Phone: +1 856 661 37 21

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.