Clinical Trials in the USA / NCT06393504
Active, not recruiting
Observational
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
NCT06393504 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Insomnia Disorder
Investigational drug(s) / intervention(s)
Daridorexant: Daridorexant received during or shortly prior to pregnancy.
Non-orexin receptor antagonist insomnia medication: Non-orexin receptor antagonist insomnia medication received during or shortly prior to pregnancy.
No insomnia medication: No insomnia medication received during or shortly prior to pregnancy.
Study summary
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
Eligibility
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.
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Carelon Research | Wilmington | Delaware |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06393504 on ClinicalTrials.gov ↗ ← All trials in the USA