A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lemborexant tablets.
- Who it may be relevant to
- Registry conditions: Insomnia, Psychiatric Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Prospective, Single-Arm, Observational Study on Effectiveness and Safety of Lemborexant on Insomnia Patients With Psychiatric Disorders
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in Insomnia Severity Index (ISI) Score from Baseline [Time frame: Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatment]
Secondary outcome measures (7)
- ISI Treatment Response Rate [Time frame: Measurement time points: Week 4 and Week 8 of treatment]
- ISI Remission Rate [Time frame: Measurement time points: Week 4 and Week 8 of treatment]
- Change in Sleep Satisfaction VAS Score [Time frame: Measurement time points: Baseline, Week 4 and Week 8 of treatment]
- Change in Epworth Sleepiness Scale (ESS) Score [Time frame: Measurement time points: Baseline, Week 4 and Week 8 of treatment]
- Lemborexant Treatment Retention Rate [Time frame: Week 4 and Week 8 of treatment]
- BZRAs Discontinuation Rate [Time frame: Measurement time points: Week 4 and Week 8 of treatment]
- BZRAs Dose Change [Time frame: Measurement time points: Week 4 and Week 8 of treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 9 centers
- Suzhou GuangJi Hospital — Suzhou
- Xuzhou Oriental People's Hospital — Xuzhou
- Shanghai Mental Health Center — Shanghai
- Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
- Shanghai Pudong New Area Mental Health Center — Shanghai
- Shanghai Fengxian District Mental Health Center — Shanghai
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine — Hangzhou
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
- … and 1 more center
Identifiers
NCT: NCT07417813 · MZhao-025