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

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: Lemborexant

• Registration Number: NCT04573556
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Study Start: 2020-10-17
• Status Verified: 2021-09
• Primary Completion: 2022-03-17
• Study Completion: 2022-03-17
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lemborexant	Lemborexant	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)	Up to 24 Weeks	The adverse events considered by the investigators to be related to treatment with lemborexant will be classified as ADRs. The incidence of somnolence, parasomnia symptoms (nightmare, abnormal dreams, exploding head syndrome etc.), narcoleptic symptoms (sleep paralysis, hypnagogic hallucination, hypnopompic hallucination and cataplexy etc.), and suicidal ideation/suicidal behavior (intentional overdose, self-injurious ideation, suicidal ideation etc.) will be determined.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Response to Treatment	Up to 24 Weeks	Response to treatment will be assessed by the impression of general improvement consisting of "Improvement", "No change", and "Worsening". One of these ratings will be selected based on physician's impression according to participants' complaints of insomnia symptoms and will be recorded in Electronic Data Capture (EDC).

Trial Locations

Locations (3)

Eisai trial site 1; 🇯🇵 Nagoya, Japan

Eisai trial site 3; 🇯🇵 Tokyo, Japan

Eisai trial site 2; 🇯🇵 Osaka, Japan