NCT07417813

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 121 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: The incidence of insomnia in patients with psychiatric disorder is as high as 70%-80%. Traditional benzodiazepine receptor agonists have risks such as addiction and cognitive impairment. Lemborexant was approved for marketing in China in 2025, but its real-world data in the population with insomnia comorbid with psychiatric disorder is insufficient. Hypothesis: 8-week treatment with lemborexant can significantly improve insomnia symptoms in insomnia comorbid with psychiatric disorders, with good safety. Design: A multicenter, prospective, single-arm, observational study. It is planned to enroll 121 patients (with an expected dropout rate of 30%), who will receive 8-week treatment. Efficacy will be evaluated by scales such as ISI and VAS, and adverse events will be monitored.

Conditions

• Insomnia
• Psychiatric Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-24
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

9 sites across 1 country: China