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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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