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.
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
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
Parallel
Daridorexant
DrugDaridorexant 50 mg tablets
Placebo
DrugMatching placebo tablets
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.
Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score (SDS)
The IDSIQ is a validated patient-reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., Alert/Cognition, Mood, and Sleepiness) reflecting daytime impairment of insomnia. The SDS ranges from 0 to 40. A higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Total Score (TS)
The IDSIQ comprises three domains: Alert/Cognition (maximum score: 60), Mood (maximum score: 40), and Sleepiness (maximum score: 40), resulting in a TS ranging from 0 to 140. A higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
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