Daridorexant Interactions

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to QUVIVIQ during pregnancy. Pregnant women exposed to QUVIVIQ and healthcare providers are encouraged to call Idorsia Pharmaceuticals Ltd at 1-833-400-9611. Risk Summary There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of daridorexant to pregnant rats and rabbits during the period of organogenesis did not cause fetal toxicity or malformation at doses up to 8 and 10 times the maximum recommended human dose (MRHD) of 50 mg, respectively, based on AUC. Oral administration of daridorexant to pregnant and lactating rats did not cause any maternal or developmental toxicity at doses up to 9 times the MRHD, based on AUC (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Daridorexant was administered orally to pregnant rats during the period of organogenesis at doses of 30, 100, and 300 mg/kg/day, which are approximately 1, 3, and 8 times the MRHD of 50 mg, respectively, based on AUC. Daridorexant did not cause any maternal or embryofetal toxicities or fetal malformation at doses up to 300 mg/kg/day. The NOAEL for maternal and fetal toxicity is 300 mg/kg/day, which is approximately 8 times the MRHD of 50 mg, based on AUC. Daridorexant was administered orally to pregnant rabbits during the period of organogenesis at doses of 30, 60, and 120 mg/kg/day, which are approximately 3, 4, and 10 times the MRHD of 50