A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders

NCT07417813 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Mental Health Center

Phase

Observational

Started

2026-01-24

Last updated

2026-02-18

Condition(s) studied

InsomniaPsychiatric Disorders

Investigational drug(s) / intervention(s)

Lemborexant tablets

Lemborexant tablets: Lemborexant Tablets (Dayvigo® tablets 5 mg): Oral administration, taken before bedtime. The initial dose is 5mg/day, which can be adjusted to 10mg/day (maximum dose: 10mg/day) based on clinical response and tolerability. For patients using benzodiazepine receptor agonists(BZRAs) at baseline, it is recommended to gradually reduce and discontinue BZRAs within the first 4 weeks.

Study summary

This study aims to evaluate the effectiveness and safety of lemborexant (a new dual orexin receptor antagonist) in the treatment of patients with mental disorders complicated with insomnia. The subjects are patients aged 18 years and above, who meet the DSM-5 diagnostic criteria for mental disorders and have an Insomnia Severity Index (ISI) score ≥11. They will receive lemborexant treatment for 8 weeks, with follow-up to observe the improvement of insomnia symptoms and adverse events, so as to provide real-world evidence for the clinical optimization of treatment regimens for insomnia comorbid with psychiatric disorders.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Change in Insomnia Severity Index (ISI) Score from Baseline — Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatment
Change in Insomnia Severity Index (ISI) Score from Baseline: Evaluated by the ISI scale (7 items, total score 0-28 points).

Trial sites (9)

Facility	City	Region	Status
Suzhou GuangJi Hospital	Suzhou	Jiangsu	Recruiting
Xuzhou Oriental People's Hospital	Xuzhou	Jiangsu	Recruiting
Shanghai Mental Health Center	Shanghai	Shanghai Municipality	Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality	Recruiting
Shanghai Pudong New Area Mental Health Center	Shanghai	Shanghai Municipality	Recruiting
Shanghai Fengxian District Mental Health Center	Shanghai	Shanghai Municipality	Recruiting
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting
The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07417813 on ClinicalTrials.gov ↗ ← All trials in China