RecruitingNCT07417813

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

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

Sponsor

Shanghai Mental Health Center

Enrollment

121 participants

Start Date

Jan 24, 2026

Study Type

OBSERVATIONAL

Conditions

Insomnia Psychiatric Disorders

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lemborexant tablets for people with insomnia and psychiatric disorders. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLemborexant 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.