Is Daridorexant safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Daridorexant. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Three major metabolites of daridorexant with much lower affinity to orexin receptors than the parent drug have been identified in plasma, but they do not appear to contribute to the pharmacological effect of daridorexant.[ 1 ] Maternal Levels. In a manufacturer-sponsored study, 10 healthy women who were at least 2 weeks postpartum were given a single 50 mg oral dose of daridorexant. Milk was collected either every 4 or 8 hours for 3 days. The peak daridorexant milk level of 35.3 mcg/L occurred 2 hours after the dose. The metabolites M1, M3 and M10 had peak milk levels of 5.61 mcg/L, 9.1 mcg/L and 3.7 mcg/L, respectively. Peak levels of M3 and M10 occurred at 2 hours after the dose, while the peak level of M1 occurred at 6 hours after the dose. The mean daridorexant milk concentration was 6.3 mcg/L and its half-life was 7 hours. It was estimated that 9 mcg of daridorexant was excreted into milk in the first 24 hours after a dose and 10 mcg over 72 hours. The mean absolute infant dose of daridorexant was 0.0016 mg/kg daily and the relative infant dose was 0.22% in the first 24 hours and 0.25% over 72 hours.[ 1 ] Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
“No published information” means the studies do not exist yet — not that Daridorexant is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.