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

NCT07417813 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2026-02-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Shanghai Fengxian District Mental Health Center

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • First Affiliated Hospital of Ningbo University

    collaborator NETWORK

  • Xuzhou Oriental People's Hospital

    collaborator UNKNOWN

  • Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University

    collaborator OTHER

  • Suzhou Guangji Hospital

    collaborator UNKNOWN

  • Shanghai Mental Health Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-24
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07417813 on ClinicalTrials.gov