NCT06225947

Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Lemborexant 5 MG	The recommended dosage of Lemborexant(LEM) is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability.

Timeline

• Start date: 2024-02-22
• Primary completion: 2025-03-30
• Completion: 2025-06-30
• First posted: 2024-01-26
• Last updated: 2024-07-30

Locations

5 sites across 1 country: China