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

Idorsia Pharmaceuticals

Status: Active, not recruiting

Conditions: Insomnia Disorder

Treatments: Drug: Daridorexant; Drug: Non-orexin receptor antagonist insomnia medication; Other: No insomnia medication

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06393504

ID-078A404

Details and patient eligibility

About

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

Full 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).

Enrollment: 2,095 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Evidence of a singleton end of pregnancy event during the intake period.
2. ≥ 1 insomnia diagnosis during the period which begins 12 months prior to the date of conception and ends at the end of pregnancy.
3. Continuous medical and pharmacy insurance coverage during the period which begins 6 months prior to the date of conception and ends at the date of conception plus 40 weeks (equivalent to 42 gestational weeks).
4. Age 15 to 50 years at the date of conception.
5. No dispensing of known or suspected teratogenic medications during the period which begins 5 half lives of that medication prior to the date of conception and ends at the end of pregnancy.
6. No exposure to other orexin receptor antagonists during the exposure period, i.e., suvorexant, lemborexant, and any orexin receptor antagonists newly approved during the intake period.

Trial design

2,095 participants in 3 patient groups

QUVIVIQ-exposed group

Description:

Pregnant women with insomnia exposed to QUVIVIQ during pregnancy or within 5 half-lives prior to date of conception.

Treatment:

Drug: Daridorexant

Active comparator group

Description:

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.

Treatment:

Drug: Non-orexin receptor antagonist insomnia medication

Unexposed comparator group

Description:

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.

Treatment:

Other: No insomnia medication