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

NCT04573556 | Completed

• 1 other identifier: E2006-M081-501
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 3

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

E2006; Lemborexant; Insomnia; Non-interventional; Dayvigo

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)

  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.

  Up to 24 Weeks

Secondary Outcomes (1)

• Number of Participants With Response to Treatment

  Up to 24 Weeks

Study Arms (1)

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.

Drug: Lemborexant

Interventions

Lemborexant DRUG

Lemborexant oral tablets.

Also known as: E2006, DAYVIGO

Lemborexant

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 300 participants with insomnia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (3)

Eisai trial site 1

Nagoya, Japan

Location

Eisai trial site 2

Osaka, Japan

Location

Eisai trial site 3

Tokyo, Japan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: October 17, 2020
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: April 5, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)