Is Pitolisant safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Pitolisant. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
No information is available on the clinical use of pitolisant during breastfeeding. However, amounts in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. If pitolisant is required by the mother, it is not a reason to discontinue breastfeeding. Until more safety data are available, pitolisant should be used with careful infant monitoring during breastfeeding.
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: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Pitolisant” (pitolisant). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.