Is Pitolisant safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Pitolisant. 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
Maternal Levels. The manufacturer reports an open-label study in 8 healthy lactating women who were 11 to 96 weeks post-partum. Breastmilk samples were collected over 24 hours after a single dose of 35.6 mg of pitolisant. Pitolisant had a mean peak milk concentration of 47.5 mcg/L with about 50% of the amount of pitolisant measured in breastmilk found during the first 4 hours after the maternal dose. The mean infant dosage of pitolisant was calculated to be 0.009 mg daily, which represented a mean relative infant dose of 0.56% of the maternal weight-adjusted dosage. 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 Pitolisant 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.