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

ID-078A404

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

2023-11-30

2028-04-01

2028-04-01

Active (not recruiting)

2095

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. Date of conception ≥ 42 weeks before the end of the intake period. 4. Age 15 to 50 years at the date of conception. 5. Continuous medical and pharmacy insurance coverage during the period which begins 6 months prior to the date of conception and ends at the end of pregnancy. 6. 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. 7. 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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 2095, 'type': 'ESTIMATED'}}

2024-05-01