Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients（EAS… (NCT07733414) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients（EASY-TIP）
China156 participantsStarted 2026-08-01
Plain-language summary
Brief Summary:
This study is a prospective, multicenter, open-label cohort study designed to evaluate the efficacy and safety of transitioning adult patients with insomnia from benzodiazepine receptor agonists (BZRAs) to daridorexant.
A total of 156 participants will be enrolled. The study consists of a 1-week baseline phase and a 9-week daridorexant treatment phase. During the treatment phase, daridorexant 50 mg is initiated once daily while BZRAs are gradually tapered and discontinued based on individual patient response.
The primary outcome is the proportion of patients who successfully transition from BZRAs to daridorexant at Week 5, defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant and no withdrawal due to worsening insomnia or adverse events. Secondary outcomes include changes in Insomnia Severity Index (ISI) scores and patient-reported sleep outcomes.
This study aims to provide real-world evidence for the safe and effective transition from BZRAs to daridorexant in clinical practice.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, aged ≥18 and ≤70 years.
. Meet DSM-5 diagnostic criteria for insomnia disorder: dissatisfaction with nighttime sleep despite adequate sleep opportunity, manifested as difficulty initiating sleep, difficulty maintaining sleep (frequent awakenings or difficulty returning to sleep after awakening), or early-morning awakening with inability to resume sleep, accompanied by subjective experience of daytime dysfunction. Symptoms occur ≥3 times per week and persist for ≥3 months.
. Received stable BZRA monotherapy for at least 3 nights per week during the 1 month prior to enrollment.
. Bedtime duration of no less than 7 hours per night.
. Unsatisfactory response or intolerance to current therapy, with clinical need to adjust insomnia medication regimen.
. Hamilton Anxiety Rating Scale (HAMA-14) score \<14.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Successfully Transitioning from BZRAs to Daridorexant at Week 5
. Hamilton Depression Rating Scale (HAMD-17) score \<17.
. Willing and able to comply with the study protocol and provide written informed consent.
Exclusion criteria
. History of chronic insomnia \>5 years.
. Other sleep disorders such as narcolepsy-related symptoms, restless legs syndrome, circadian rhythm sleep disorder, REM sleep behavior disorder, etc.
. Daytime napping ≥1 hour/day and ≥3 days/week.
. Daily BZRA dose exceeding the maximum recommended dose for insomnia treatment per package insert.
. BZRA use \>5 nights per week.
. History of BZRA treatment ≥3 years.
. Concurrent use of two or more BZRAs within the past 3 months.
. Use of central nervous system depressants within the past 3 months.