A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.

Eisai

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Lemborexant

Study type: Observational

Funder types: Industry

Identifiers

NCT04573556

E2006-M081-501

Details and patient eligibility

About

The purpose of the study is to evaluate the incidence of somnolence, parasomnia, narcoleptic symptoms, and suicidal ideation/suicidal behavior after administration of lemborexant (DAYVIGO) in daily practice.

Enrollment: 550 patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants who are treated with lemborexant
2. Participants who provide consent for participation in the study
3. Participants who were registered in EDC by 14 days after DAYVIGO treatment initiation

Exclusion criteria

1. Participants who were enrolled in this study before obtaining informed consent of this study
2. Participants who were participating in a clinical trial at the time of this study

Trial design

550 participants in 1 patient group

Lemborexant

Description:

Participants with insomnia will initiate treatment with lemborexant 5 milligram (mg), tablet, orally as per the clinical judgment of the treating physician as part of routine clinical care. Dosage and administration of lemborexant tablet will be according to package insert and actual dosing and frequency will be decided by physician including dose escalation from initial dose of 5 mg up to 10 mg once daily. All participants will be observed prospectively for up to 24 weeks.

Treatment:

Drug: Lemborexant