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Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia — PROEM  

Insomnia Clinical Trial

Official title:
A Prospective, Multi-center, 3-month, Observational Study to Evaluate the Effectiveness and Safety of Lemborexant in Chinese Patients With Insomnia in Real World Setting.

Clinical Trial Summary

This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Patient self-evaluation reports and safety events will be collected at baseline and 4 visits during treatment.

Clinical Trial Description

This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Adult patients diagnosed with insomnia (including chronic and short-term insomnia) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and ISI ≥10, clinically judged to need pharmacological treatment will be enrolled.Patients will be administered with LEM, and patient self-evaluation reports and safety events will be collected at baseline and each visit during treatment. ;

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT06225947
Study type Observational
Source Guangdong Provincial People's Hospital
Contact Xueli Li, Master
Phone 15876549787
Email lixueli@gdph.org.cn
Status Not yet recruiting
Phase
Start date February 1, 2024
Completion date June 30, 2025
View Details
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