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
Shanghai Mental Health Center
121 participants
Jan 24, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria9
- 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
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07417813