NCT06498128

Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

QUVIVIQ® Pregnancy Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 785 (estimated)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Daridorexant	Dosing and treatment duration of QUVIVIQ as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
DRUG	Non-orexin receptor antagonist medications for insomnia	Dosing and treatment duration of non-orexin receptor antagonist medications for insomnia as part of this observational study is at the discretion of the healthcare provider in accordance with local clinical practice and local labeling.
OTHER	No insomnia medication	No insomnia medication was administered.

Timeline

• Start date: 2024-11-21
• Primary completion: 2033-03-01
• Completion: 2033-03-01
• First posted: 2024-07-12
• Last updated: 2025-12-02

Locations

7 sites across 7 countries: United States, Canada, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study