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

February 13, 2026 updated by: Shanghai Mental Health Center

A Multicenter, Prospective, Single-Arm, Observational Study on Effectiveness and Safety of Lemborexant on Insomnia Patients With Psychiatric Disorders

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wenzheng Wang, PhD
  • Phone Number: 18017311500
  • Email: fffty@163.com

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • Suzhou Guangji Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • Xuzhou Oriental People's Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Shanghai Pudong New Area Mental Health Center
        • Contact:
      • Shanghai, Shanghai Municipality, China, 201400
        • Recruiting
        • Shanghai Fengxian District Mental Health Center
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
        • Contact:
      • Ningbo, Zhejiang, China, 315000
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insomnia Severity Index (ISI) Score from Baseline
Time Frame: 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).
Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ISI Treatment Response Rate
Time Frame: Measurement time points: Week 4 and Week 8 of treatment
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
Time Frame: Measurement time points: Week 4 and Week 8 of treatment
Proportion of patients with an ISI score <8 points.
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
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
Time Frame: Measurement time points: Baseline, Week 4 and Week 8 of treatment
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
Time Frame: 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;
Week 4 and Week 8 of treatment
BZRAs Discontinuation Rate
Time Frame: Measurement time points: Week 4 and Week 8 of treatment
Discontinuation rate of patients using BZRAs at baseline
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
Change in diazepam-equivalent dose from baseline
Measurement time points: Week 4 and Week 8 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZhao-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on Lemborexant tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe