Lemborexant for insomnia in people with psychiatric conditions

A Multicenter, Prospective, Single-Arm, Observational Study on Effectiveness and Safety of Lemborexant on Insomnia Patients With Psychiatric Disorders

We will try lemborexant for 8 weeks in adults with psychiatric disorders who have insomnia to see if it helps them sleep better and is safe.

Quick facts

• Study type: Observational
• Enrollment: 121 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 9 sites (Suzhou, Jiangsu and 8 other locations)
• Trial ID: NCT07417813 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older who meet DSM-5 criteria for a psychiatric disorder, have an ISI score ≥11, can commit to roughly 8 weeks of treatment and follow-up, and whose clinicians plan to start lemborexant are the intended participants.

Not a fit: Patients in an acute psychiatric episode or with unstable psychotropic dosing, high suicide risk, narcolepsy, severe liver failure, pregnancy or breastfeeding, recent DORA use, or concurrent use of multiple benzodiazepine-receptor agonists are unlikely to benefit or be appropriate for this protocol.

Why it matters

Potential benefit: If successful, the study could show that lemborexant improves sleep in people with psychiatric disorders and offers a safer alternative to benzodiazepine-type sleep drugs.

How similar studies have performed: Other randomized trials of lemborexant and similar dual orexin receptor antagonists have shown efficacy for primary insomnia, but real-world data specific to patients with comorbid psychiatric disorders remain limited.

Eligibility criteria

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 this trial is running

Suzhou, Jiangsu and 8 other locations

• 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)
• Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Wenzheng Wang, PhD

Conditions Insomnia; Psychiatric Disorders; Lemborexant; Dual Orexin Receptor Antagonist; Real-World Study