Daridorexant for Insomnia
(DARI-DREAM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Global Clinical Development
Principal Investigator
Idorsia Pharmaceuticals Ltd.
Are You a Good Fit for This Trial?
This trial is for adults aged 18 and older who have been diagnosed with insomnia, sleep less than or equal to 6.5 hours per night on average, and have had trouble falling or staying asleep at least three nights a week for the past three months.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Daridorexant
Trial Overview
The study tests whether daridorexant (50 mg daily) helps people with insomnia sleep better at night and function better during the day compared to a placebo. Participants are randomly assigned to either daridorexant or placebo for about three months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 50 mg daridorexant orally, once daily for approximately 3 months.
Participants will receive placebo orally, once daily for approximately 3 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Idorsia Pharmaceuticals Ltd.
Lead Sponsor
Antonio Olivieri
Idorsia Pharmaceuticals Ltd.
Chief Medical Officer since 2024
Not specified
André C. Muller
Idorsia Pharmaceuticals Ltd.
Chief Executive Officer
Not specified
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