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A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
Sponsor: Shanghai Mental Health Center
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
Conditions
Interventions
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