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

Active, not recruiting

• Conditions: Insomnia Disorder
• Interventions: Other: No insomnia medication; Drug: Daridorexant; Drug: Non-orexin receptor antagonist insomnia medication

• Registration Number: NCT06393504
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief 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).

Study Timeline

• Study Start: 2023-11-30
• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-05-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2095

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unexposed comparator group	No insomnia medication	Pregnant women with insomnia unexposed to insomnia medications during pregnancy and within 5 half-lives of any insomnia medication taken prior to date of conception.
QUVIVIQ-exposed group	Daridorexant	Pregnant women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to date of conception.
Active comparator group	Non-orexin receptor antagonist insomnia medication	Pregnant women with insomnia exposed to non-orexin receptor antagonist insomnia medications during pregnancy or within 5 half-lives of the respective insomnia medication prior to date of conception.

Primary Outcome Measures

Name	Time	Method
Prevalence of major congenital malformations (MCMs)	From May 2022 to April 2028 (6 years)	MCMs will be identified as pre-specified diagnostic codes for malformations included in the National Birth Defects Prevention Network's birth defects descriptions (identified through maternal and infant claims).; MCMs with etiologies presumed not to be associated with drug exposure, such as chromosomal abnormalities, genetic syndromes, prematurity-related defects, and positional effects, will be excluded from the definition of MCMs.

Secondary Outcome Measures

Name	Time	Method
Prevalence of spontaneous abortions (SABs)	From May 2022 to April 2028 (6 years)	An SAB is defined as the loss of an embryo before 20 gestational weeks (identified through maternal claims).
Prevalence of stillbirths (SBs)	From May 2022 to April 2028 (6 years)	An SB is defined as the loss of a fetus at or after 20 gestational weeks (identified through maternal claims).
Prevalence of small for gestational age infants (SGAs)	From May 2022 to April 2028 (6 years)	SGA is defined as birth weight less than or equal to the tenth percentile for gestational age (identified through maternal and infant claims).
Prevalence of preterm births (PTBs)	From May 2022 to April 2028 (6 years)	PTB is defined as a live birth before 37 gestational weeks (identified through maternal and infant claims).
Prevalence of induced abortions (IABs)	From May 2022 to April 2028 (6 years)	An IAB is defined as the elective termination of the pregnancy (identified through maternal claims).

Trial Locations

Locations (1)

Carelon Research; 🇺🇸 Wilmington, Delaware, United States