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

NCT07843329 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: ID-078A3062026-525730-38-00
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Month 3 in Subjective Total Sleep Time (sTST)

  Subjective Total Sleep Time (sTST) is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. A negative change from baseline indicates a decrease in sTST.

  Baseline and Month 3

Secondary Outcomes (2)

• Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score (SDS)

  Baseline and Month 3

• Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Total Score (TS)

  Baseline and Month 3

Study Arms (2)

Daridorexant

EXPERIMENTAL

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

Drug: Daridorexant

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Daridorexant DRUG

Daridorexant 50 mg tablets

Daridorexant

Placebo DRUG

Matching placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

MeSH Terms

Interventions

daridorexant

Study Officials

• Global Clinical Development

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Central Study Contacts

Idorsia Clinical Trial Information USA

CONTACT

+1 856 661 37 21; idorsiaclinicaltrials@idorsia.com

Idorsia Clinical Trial Information Europe

CONTACT

+41 58 844 1977; idorsiaclinicaltrials@idorsia.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share