NCT06393504

Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

Healthcare Claims Database Study to Provide Safety Information on Maternal, Fetal and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) During Pregnancy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,095 (estimated)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy

Detailed description

This is a longitudinal observational cohort study using an electronic database of healthcare claims data. Safety information will be retrospectively collected from the database and pre-specified diagnostic codes will be used to identify pregnancy and infant outcomes. The study will include two phases, a patient accrual phase (Phase 1) and an analysis phase (Phase 2). Descriptive statistics will be conducted to characterize the patient population and to support the interpretation of comparative analyses. Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes. Approximately 419 mother-infant pairs with exposure to QUVIVIQ and 1676 mother-infant pairs with exposure to non-orexin receptor antagonist insomnia medication are expected with a 1:4 ratio of exposed:active comparator patients. Analysis of the prevalence of each specific pregnancy or infant outcome will comprise: (1) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia exposed to any non-orexin receptor antagonist insomnia medication during or shortly prior to pregnancy (active comparator group); (2) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia unexposed to any insomnia medication during or shortly prior to pregnancy (unexposed comparator group).

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	Daridorexant	Daridorexant received during or shortly prior to pregnancy.
DRUG	Non-orexin receptor antagonist insomnia medication	Non-orexin receptor antagonist insomnia medication received during or shortly prior to pregnancy.
OTHER	No insomnia medication	No insomnia medication received during or shortly prior to pregnancy.

Timeline

• Start date: 2023-11-30
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2024-05-01
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study