NCT07843329 · Idorsia Pharmaceuticals Ltd.
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
(DARI-DREAM)
What this study is about
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.
View original scientific 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. 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.
Interventions
DRUG
Daridorexant
Daridorexant 50 mg tablets
DRUG
Placebo
Matching placebo tablets
Primary outcome measures
Change from baseline to Month 3 in Subjective Total Sleep Time (sTST)
Time frame: Baseline and Month 3
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Little Rock, Arkansas
- Lemon Grove, California
- Pomona, California
- Brandon, Florida
- Virginia Gardens, Florida
- Weston, Florida
- Huntersville, North Carolina
- Raleigh, North Carolina
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 5, 2026 · Source of record for eligibility and locations