Insomnia, Psychiatric Disorders
Conditions
Keywords
Lemborexant, Psychiatric Disorders, Insomnia, Dual Orexin Receptor Antagonist, Real-World Study
Brief 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.
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
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.
Sponsors
Shanghai Mental Health Center
RenJi Hospital
Shanghai Fengxian District Mental Health Center
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years and above, regardless of gender; 2. Meet the DSM-5 diagnostic criteria for mental disorders (any type); 3. Insomnia Severity Index (ISI) score ≥11; 4. Have at least 7 hours of sleep time available; 5. Able to complete the 2-month scale assessment and follow-up plan; 6. Voluntarily sign the informed consent form; 7. Intend to receive lemborexant treatment as judged by the clinicians
Exclusion criteria
1. 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; 2. Concurrent use of ≥2 types of benzodiazepine receptor agonists (BZRAs) as insomnia treatment drugs; 3. Previous continuous use of dual orexin receptor antagonist (DORA)-type drugs for \>1 week; 4. Clear suicide attempt/plan or high suicide risk as judged by the researcher; 5. Pregnant or lactating women; 6. Patients with narcolepsy; 7. Patients with severe hepatic insufficiency; 8. Currently accompanied by severe or unstable diseases of cardiovascular, respiratory, digestive and other systems; 9. Other conditions deemed unsuitable for participation by the researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index (ISI) Score from Baseline | Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatment | Change in Insomnia Severity Index (ISI) Score from Baseline: Evaluated by the ISI scale (7 items, total score 0-28 points). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ISI Treatment Response Rate | Measurement time points: Week 4 and Week 8 of treatment | Proportion of patients with an ISI score decrease of ≥7 points from baseline. |
| ISI Remission Rate | Measurement time points: Week 4 and Week 8 of treatment | Proportion of patients with an ISI score \<8 points. |
| Change in Sleep Satisfaction VAS Score | Measurement time points: Baseline, Week 4 and Week 8 of treatment | Including 3 dimensions (sleep onset efficiency, sleep maintenance, impact on daytime function) with 1-10 points for each dimension. |
| Change in Epworth Sleepiness Scale (ESS) Score | Measurement time points: Baseline, Week 4 and Week 8 of treatment | Change in Epworth Sleepiness Scale (ESS) Score: Total score 0-24 points. |
| Lemborexant Treatment Retention Rate | Week 4 and Week 8 of treatment | Lemborexant Treatment Retention Rate: Proportion of patients still using lemborexant at Week 4 and Week 8 of treatment; |
| BZRAs Discontinuation Rate | Measurement time points: Week 4 and Week 8 of treatment | Discontinuation rate of patients using BZRAs at baseline |
| BZRAs Dose Change | Measurement time points: Week 4 and Week 8 of treatment | Change in diazepam-equivalent dose from baseline |
Countries
China
Contacts
CONTACTWenzheng Wang, PhD
Outcome results
None listed