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

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Multicenter, Post-marketing Observational (Non-interventional) Study to Evaluate the Safety of DAYVIGO Tablet in Patients With Insomnia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573556
• Other study ID #: E2006-M081-501
• Status: Completed
• Start date: October 17, 2020
• Est. completion date: March 17, 2022

Study information

• Verified date: September 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Lemborexant
Lemborexant oral tablets.

Locations

Country	Name	City	State
Japan	Eisai trial site 1	Nagoya
Japan	Eisai trial site 2	Osaka
Japan	Eisai trial site 3	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Response to Treatment	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).	Up to 24 Weeks