A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
Key facts
- Where
- Hangzhou, Ningbo, Shanghai, Suzhou, and Xuzhou, ChinaSee the 9 sites
Where in China
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of MedicineHangzhou, ChinaContact: Jinsong TangTaking people
- The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaContact: Zheng LinTaking people
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaContact: Yunxin JiTaking people
- Renji Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaContact: Yanli Luo, PhDTaking people
- Shanghai Fengxian District Mental Health CenterShanghai, ChinaContact: Ping ZhangTaking people
- Shanghai Mental Health CenterShanghai, ChinaContact: Min Zhao, PhDTaking people
- Shanghai Pudong New Area Mental Health CenterShanghai, ChinaContact: Jingjing Huang, PhDTaking people
- Suzhou Guangji HospitalSuzhou, ChinaContact: Chuanwei LiTaking people
- Xuzhou Oriental People's HospitalXuzhou, ChinaContact: Bo LiTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Mental Health Center
- Trial code
- NCT07417813
- Record updated
- 18 February 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Prospective, Single-Arm, Observational Study on Effectiveness and Safety 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.
Inclusion: 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: 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; 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; 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; Clear suicide attempt/plan or high suicide risk as judged by the researcher; Pregnant or lactating women; Patients with narcolepsy.