Evaluating the effects of lemborexant on insomnia in Chinese adults

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.

This study is testing if a medication called lemborexant can help adults in China with insomnia sleep better and feel safer while using it.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Locations: 5 sites (Guangzhou, Guangdong and 4 other locations)
• Trial ID: NCT06225947 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and safety of lemborexant in treating insomnia among adult patients in China. It is a prospective, open-label, single-arm, multicenter study lasting 12 weeks, where participants will be monitored through self-evaluation reports and safety assessments at baseline and during four follow-up visits. Eligible participants must have a diagnosis of insomnia according to DSM-5 criteria and an Insomnia Severity Index score greater than 10. The study will provide insights into the real-world application of lemborexant for insomnia management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with insomnia who meet specific severity criteria.

Not a fit: Patients with severe psychiatric disorders or those who cannot comply with the study requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable data on the effectiveness of lemborexant for improving sleep quality in patients with insomnia.

How similar studies have performed: Other studies have shown promise in evaluating the effectiveness of lemborexant for insomnia, suggesting that this approach is supported by prior research.

Eligibility criteria

Inclusion Criteria:

* Adults (≥18 years) and agreed to participate in the study, regardless of gender.
* Diagnosed with insomnia according to DSM-5.
* Insomnia Severity Index (ISI) score \>10.
* Subjects who can guarantee at least 7 hours of bedtime.
* Subjects signed informed consent forms after the prescription.

Exclusion Criteria:

* Beings unable to understand the questionnaire.
* PHQ-9 scores ≥ 20.
* GAD-7 scores ≥ 15.
* Suicidal thoughts/behaviors in the past one month or history of suicide, etc.
* Severe psychiatric disorder in the judgment of the investigator prevents completion of the trial.
* History of serious illness, mental illness, medication use, and uncontrolled poor sleep habits that the investigator believes interfere with the study evaluation or the safety of the subject.
* According to the precautions listed in the instructions, there are any contraindications or other conditions for which the use is prohibited (such as narcolepsy, severe liver damage, pregnant, nursing or pregnant women, etc.).
* Other conditions not considered appropriate for participation by clinicians.

Where this trial is running

Guangzhou, Guangdong and 4 other locations

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
• Guangzhou United Family Hospital — Guangzhou, Guangdong, China (Recruiting)
• Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)
• Clifford Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Fujun Jia, MD — Guangdong Provincial People's Hospital
• Study coordinator: Xueli Li, Master

Conditions Insomnia; insomnia; lemborexant