Quviviq Use In Pregnancy & Lactation

Pregnancy: There are no data on the use of daridorexant in pregnant women. Animal studies did not indicate harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Consequently, QUVIVIQ should be used during pregnancy only if the clinical condition of the pregnant woman requires treatment with daridorexant.
Breast-feeding: It is unknown whether daridorexant or its metabolites are excreted in human milk. Available data in animals have shown excretion of daridorexant and its metabolites in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk of excessive somnolence to the breastfed infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from QUVIVIQ therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data concerning the effect of exposure to daridorexant on human fertility. Animal studies indicate no impact on male or female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).