InsomniaNCT07417813
A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
An observational study of Insomnia and Psychiatric Disorders, run by Shanghai Mental Health Center at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Psychiatric Disorders
- What is being tested?
- Lemborexant tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 121 participants
- Where
- 9 sitesChina
- Study dates
- 24 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jinsong Tang, 0571-86006663, tangjinsonghn@163.com
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Zheng Lin, 0571-87783777, linzzr@126.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Yunxin Ji, 0574-87085588, janegege123@163.com
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Min Zhao, PhD, 021-32100600, drminzhao@gmail.com
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200120
Yanli Luo, PhD, 021-68383204, luoluoyanli@163.com
- Recruiting
Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality, 200120
Jingjing Huang, PhD, 021-68306699, huangjingjing18@tongji.edu.cn
- Recruiting
Shanghai Fengxian District Mental Health Center
Shanghai, Shanghai Municipality, 201400
Ping Zhang, 021-57120995, fxjwzxzp@163.com
- Recruiting
Suzhou GuangJi Hospital
Suzhou, Jiangsu, 215000
Chuanwei Li, 0512-65331367, avylee@163.com
- Recruiting
Xuzhou Oriental People's Hospital
Xuzhou, Jiangsu, 221000
Bo Li, 0516-69850700, 411026836@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia, Psychiatric Disorders
- Being tested
- Lemborexant tablets
- Keywords
- Lemborexant, Psychiatric Disorders, Insomnia, Dual Orexin Receptor Antagonist, Real-World Study
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Lemborexant tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatment
Secondary outcomes (7)
ISI Treatment Response Rate
Proportion of patients with an ISI score decrease of ≥7 points from baseline.
Measured: Measurement time points: Week 4 and Week 8 of treatment
ISI Remission Rate
Proportion of patients with an ISI score <8 points.
Measured: 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.
Measured: 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.
Measured: 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;
Measured: Week 4 and Week 8 of treatment
BZRAs Discontinuation Rate
Discontinuation rate of patients using BZRAs at baseline
Measured: Measurement time points: Week 4 and Week 8 of treatment
BZRAs Dose Change
Change in diazepam-equivalent dose from baseline
Measured: Measurement time points: Week 4 and Week 8 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start24 Jan 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Shanghai Fengxian District Mental Health Center, Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417813
- Sponsor's protocol ID
- MZhao-025
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Single-Arm, Observational Study on Effectiveness and Safety of Lemborexant on Insomnia Patients With Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT07417813
- Acronym / sponsor ID
- MZhao-025
- Conditions
- Insomnia, Psychiatric Disorders
- Keywords
- Lemborexant, Psychiatric Disorders, Insomnia, Dual Orexin Receptor Antagonist, Real-World Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- RenJi Hospital, Shanghai Fengxian District Mental Health Center, Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, 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 start
- 24 Jan 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lemborexant Treatment Group | – | Drug: Lemborexant tabletsAll 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemborexant tabletsLemborexant 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. | Drug | Lemborexant Treatment Group |
Primary outcome
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).
7 secondary outcomes
ISI Treatment Response Rate
Time frame: 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
Change in Sleep Satisfaction VAS Score
Time frame: 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
Lemborexant Treatment Retention Rate
Time frame: Week 4 and Week 8 of treatment
BZRAs Discontinuation Rate
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Psychiatric Disorders, run by Shanghai Mental Health Center at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenzheng Wang, PhD (18017311500, fffty@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) Score from Baseline (time frame: Measurement time points: Baseline, Week 4 of treatment, Week 8 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.