Lemborexant for insomnia in people with psychiatric conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, single-arm observational study enrolling about 121 adults with psychiatric disorders and an Insomnia Severity Index (ISI) score of 11 or higher. Participants will receive lemborexant tablets for 8 weeks with scheduled scale-based assessments (including ISI and visual analogue scales) and safety monitoring for adverse events. The study is intended to capture real-world effectiveness and tolerability in a clinically diverse psychiatric population rather than a randomized comparison. Data will be collected across several hospitals in Shanghai and Jiangsu and used to inform clinical use of lemborexant in patients with comorbid psychiatric illness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 years and above, regardless of gender;
2. Meet the DSM-5 diagnostic criteria for mental disorders (any type);
3. Insomnia Severity Index (ISI) score ≥11;
4. Have at least 7 hours of sleep time available;
5. Able to complete the 2-month scale assessment and follow-up plan;
6. Voluntarily sign the informed consent form;
7. Intend to receive lemborexant treatment as judged by the clinicians

Exclusion Criteria:

1. Mental disorder is in the acute phase as judged by clinical assessment, or the dose of other psychotropic drugs cannot be stabilized during the study;
2. Concurrent use of ≥2 types of benzodiazepine receptor agonists (BZRAs) as insomnia treatment drugs;
3. Previous continuous use of dual orexin receptor antagonist (DORA)-type drugs for \>1 week;
4. Clear suicide attempt/plan or high suicide risk as judged by the researcher;
5. Pregnant or lactating women;
6. Patients with narcolepsy;
7. Patients with severe hepatic insufficiency;
8. Currently accompanied by severe or unstable diseases of cardiovascular, respiratory, digestive and other systems;
9. Other conditions deemed unsuitable for participation by the researcher

Where it's running

• Suzhou GuangJi Hospital
  Suzhou, Jiangsu, China Recruiting
• Xuzhou Oriental People's Hospital
  Xuzhou, Jiangsu, China Recruiting
• Shanghai Mental Health Center
  Shanghai, Shanghai Municipality, China Recruiting
• Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Pudong New Area Mental Health Center
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Fengxian District Mental Health Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Wenzheng Wang, PhD
• Email: fffty@163.com
• Phone: 18017311500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.