Daridorexant (QUVIVIQ) Pregnancy Registry to Track Maternal, Fetal, and Infant Outcomes

Insomnia is a common and often debilitating condition, affecting a significant portion of the population, including pregnant women. Managing insomnia during pregnancy presents unique challenges, as many pharmacological interventions carry potential risks to the developing fetus. While non-pharmacological approaches are often first-line, some women require medication. Daridorexant (QUVIVIQ) is a dual orexin receptor antagonist, a newer class of hypnotics that targets the wake-promoting orexin system. Comprehensive safety data for new medications, especially regarding major congenital malformations and other adverse outcomes when used during pregnancy, is crucial but often lacking from pre-market clinical trials. This registry aims to address this critical knowledge gap.

This is a prospective, observational, multi-center QUVIVIQ Pregnancy Registry (NCT06498128) designed to collect real-world safety data. Participating physicians will identify potential participants who are prescribed Daridorexant 50 mg during pregnancy. Data will be collected through a combination of healthcare claims database analysis and direct physician reporting, capturing information on maternal health, pregnancy course, and infant outcomes. The study has an estimated enrollment of 785 participants and is projected to run from November 2024 to March 2033. Primary outcomes include the incidence of major congenital malformations classified according to MACDP, as well as other adverse pregnancy and infant outcomes. A comparator group of women unexposed to Daridorexant will be used for comparison.

This is a prospective observational study that is currently recruiting participants. No findings are available yet, as data collection is ongoing until the estimated completion date of March 2033. The registry's primary objective is to gather real-world safety data on Daridorexant exposure during pregnancy, specifically focusing on maternal, fetal, and infant outcomes. Results will be reported upon study completion.