Is Ramelteon safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Ramelteon. 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
Prolactin levels increased by 4.9 mcg/L (34%) in non-breastfeeding women with chronic insomnia who were taking ramelteon 16 mg nightly for 6 months. No clinical symptoms of hyperprolactinemia were reported.[ 2 ] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Levels in milk
Ramelteon undergoes rapid and almost complete first-pass metabolism to several metabolites. The principle active metabolite is M-II, which has an elimination half-life of 2 to 5 hours in adults. Maternal Levels. A woman was taking oral ramelteon 8 mg nightly for sleep during pregnancy and postpartum while nursing. Breastmilk concentrations of ramelteon and its active M-II metabolite were measured at 3 times postpartum: on day 1 at 8.2 hours after a dose, concentrations were 0.4 and 14.6 mcg/L, respectively; day 2 at 9.1 hours after the dose, concentrations were 0.2 and 7.1 mcg/L, respectively; day 3 at 2.2 hours after the dose, concentrations were 2.6 and 88.9 mcg/L, respectively. The authors calculated that the infant would receive 0.24% of the mother s weight-adjusted dosage.[ 1 ] Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
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.