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

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.

Inclusion criteria

• Aged 18 years and above, regardless of gender;
• Meet the DSM-5 diagnostic criteria for mental disorders (any type);
• Insomnia Severity Index (ISI) score ≥11;
• Have at least 7 hours of sleep time available;
• Able to complete the 2-month scale assessment and follow-up plan;
• Voluntarily sign the informed consent form;
• Intend to receive lemborexant treatment as judged by the clinicians

Exclusion criteria

• Mental disorder is in the acute phase as judged by clinical assessment, or the dose of other psychotropic drugs cannot be stabilized during the study;
• Concurrent use of ≥2 types of benzodiazepine receptor agonists (BZRAs) as insomnia treatment drugs;
• Previous continuous use of dual orexin receptor antagonist (DORA)-type drugs for >1 week;
• Clear suicide attempt/plan or high suicide risk as judged by the researcher;
• Pregnant or lactating women;
• Patients with narcolepsy;
• Patients with severe hepatic insufficiency;
• Currently accompanied by severe or unstable diseases of cardiovascular, respiratory, digestive and other systems;
• Other conditions deemed unsuitable for participation by the researcher