NCT06744673

A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population

A Retrospective, Observational Study Using a Healthcare Database to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 861 (estimated)
• Sponsor: Eisai Inc. · Industry
• Sex: Female
• Age: 16 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are not exposed to any prescription insomnia drugs at any time during the pregnancy and to compare the occurrence of MCMs among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are exposed to a prescription insomnia drug other than Dayvigo during the 1st trimester of pregnancy.

Detailed description

As this is a Retrospective Database study, the Study Start Date for this study references the date at which data will become available

Conditions

• Sleep Initiation and Maintenance Disorders
• Pregnancy

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2025-01-03
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-12-20
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study