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

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.

NCT Number	NCT07417813
Lead Sponsor	Shanghai Mental Health Center Collaborators: RenJi Hospital, Shanghai Fengxian District Mental Health Center, Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Ningbo University, Xuzhou Oriental People's Hospital, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University, Suzhou Guangji Hospital
Conditions	Insomnia, Psychiatric Disorders
Enrollment	121 participants
Start Date	2026-01-24
Primary Completion	2026-08-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-18