A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders

NCT07417813 | Recruiting

• 1 other identifier: MZhao-025
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 9

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.

Conditions

Insomnia; Psychiatric Disorders

Keywords

Lemborexant; Psychiatric Disorders; Insomnia; Dual Orexin Receptor Antagonist; Real-World Study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• ISI Treatment Response Rate

  Measurement time points: Week 4 and Week 8 of treatment

• ISI Remission Rate

  Measurement time points: Week 4 and Week 8 of treatment

• Change in Sleep Satisfaction VAS Score

  Measurement time points: Baseline, Week 4 and Week 8 of treatment

• Change in Epworth Sleepiness Scale (ESS) Score

  Measurement time points: Baseline, Week 4 and Week 8 of treatment

• Lemborexant Treatment Retention Rate

  Week 4 and Week 8 of treatment

Study Arms (1)

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)

Drug: Lemborexant tablets

Interventions

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.

Lemborexant Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Fengxian District Mental Health Center: collaborator
• Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• First Affiliated Hospital of Ningbo University: collaborator
• Xuzhou Oriental People's Hospital: collaborator
• Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University: collaborator
• Shanghai Mental Health Center: lead
• RenJi Hospital: collaborator
• Suzhou Guangji Hospital: collaborator

Study Sites (9)

Suzhou GuangJi Hospital

Suzhou, Jiangsu, 215000, China

RECRUITING

Xuzhou Oriental People's Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Shanghai Fengxian District Mental Health Center

Shanghai, Shanghai Municipality, 201400, China

RECRUITING

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mental Disorders

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Wenzheng Wang, PhD

CONTACT

18017311500; fffty@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 18, 2026
• Study Start: January 24, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)