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NCT07417813

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

Sponsor: Shanghai Mental Health Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

121

Start Date

2026-01-24

Completion Date

2026-12-31

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (9)

Suzhou GuangJi Hospital

Suzhou, Jiangsu, China

Xuzhou Oriental People's Hospital

Xuzhou, Jiangsu, China

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, China

Shanghai Fengxian District Mental Health Center

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China