Idorsia Pharmaceuticals Ltd.
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.
The trial includes three trial periods: Following a Screening period, during which it will be checked if participants are eligible to take part, eligible participants will be randomized in a 1:1 ratio to receive either daridorexant 50 mg or placebo for ca. 3 months (Treatment period). On completion of treatment, participants will be followed for up to 10 days for safety assessments (Safety follow-up period). Trial participation will end with a Follow-up call (Participant Last Visit) at the end of the Safety follow-up period. The maximum trial duration for an individual participant will be a…
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 ≤…
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