Recruiting
Phase 3

Daridorexant

Sponsor:

Idorsia Pharmaceuticals Ltd.

Code:

NCT07843329

Conditions

Insomia Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daridorexant

Placebo

Study Details

Brief summary:

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.

Conditions

Insomia Disorder

Study ID

NCT07843329

Start date

Oct 28, 2026

Status verified date

Sep, 2026

Completion date

Dec 6, 2027

Anticipated

Primary completion date

Nov 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

344 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Daridorexant

Participants will receive 50 mg daridorexant orally, once daily for approximately 3 months.

placebo comparator: Placebo

Participants will receive placebo orally, once daily for approximately 3 months.

Interventions

Daridorexant

Daridorexant 50 mg tablets

Placebo

Matching placebo tablets

Primary outcome measure

  • Change from baseline to Month 3 in Subjective Total Sleep Time (sTST) [ Time Frame: Baseline and Month 3 ]

Central Contacts and Locations

Central contacts

Idorsia Clinical Trial Information USA

+1 856 661 37 21idorsiaclinicaltrials@idorsia.com

Idorsia Clinical Trial Information Europe

+41 58 844 1977idorsiaclinicaltrials@idorsia.com

Locations

Hope Research Network

Recruiting

Virginia Gardens, Florida, United States, 33166

More Information

Sponsor

Idorsia Pharmaceuticals Ltd.

Last update posted

Nov 5, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Idorsia Pharmaceuticals Ltd. on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.