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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Not yet enrolling

Conditions: Insomnia

Treatments: Drug: Lemborexant 5 MG

Study type: Observational

Funder types: Other

Identifiers

NCT06225947

KY2023-1072-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

200 participants in 1 patient group

Lemborexant(LEM)

Description:

Subjects will be administered with Lemborexant(LEM). The dosage of LEM is 5 mg or 10mg taken no more than once per night during the study.

Treatment:

Drug: Lemborexant 5 MG