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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Shanghai Fengxian District Mental Health Center | UNKNOWN |
| Sir Run Run Shaw Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lemborexant Treatment Group | All enrolled patients receive lemborexant treatment, with a study cycle of 8 weeks (including a baseline assessment period ≤1 week and an 8-week treatment observation period) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemborexant tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity Index (ISI) Score from Baseline | Change in Insomnia Severity Index (ISI) Score from Baseline: Evaluated by the ISI scale (7 items, total score 0-28 points). | Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ISI Treatment Response Rate | Proportion of patients with an ISI score decrease of ≥7 points from baseline. | Measurement time points: Week 4 and Week 8 of treatment |
| ISI Remission Rate | Proportion of patients with an ISI score <8 points. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults ≥18 years with any DSM-5-diagnosed mental disorder, ISI score ≥11, ≥7 hours available sleep time, ability to complete 2-month assessments/follow-up, voluntary informed consent, and clinical indication for lemborexant treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenzheng Wang, PhD | Contact | 18017311500 | fffty@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou GuangJi Hospital | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000634104 | lemborexant |
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| OTHER |
| First Affiliated Hospital of Ningbo University | NETWORK |
| Xuzhou Oriental People's Hospital | UNKNOWN |
| Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University | OTHER |
| Suzhou Guangji Hospital | UNKNOWN |
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| Measurement time points: Week 4 and Week 8 of treatment |
| Change in Sleep Satisfaction VAS Score | Including 3 dimensions (sleep onset efficiency, sleep maintenance, impact on daytime function) with 1-10 points for each dimension. | Measurement time points: Baseline, Week 4 and Week 8 of treatment |
| Change in Epworth Sleepiness Scale (ESS) Score | Change in Epworth Sleepiness Scale (ESS) Score: Total score 0-24 points. | Measurement time points: Baseline, Week 4 and Week 8 of treatment |
| Lemborexant Treatment Retention Rate | Lemborexant Treatment Retention Rate: Proportion of patients still using lemborexant at Week 4 and Week 8 of treatment; | Week 4 and Week 8 of treatment |
| BZRAs Discontinuation Rate | Discontinuation rate of patients using BZRAs at baseline | Measurement time points: Week 4 and Week 8 of treatment |
| BZRAs Dose Change | Change in diazepam-equivalent dose from baseline | Measurement time points: Week 4 and Week 8 of treatment |
| Xuzhou Oriental People's Hospital | Recruiting | Xuzhou | Jiangsu | 221000 | China |
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| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| Shanghai Pudong New Area Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| Shanghai Fengxian District Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 201400 | China |
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| Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315000 | China |
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