Is Ramelteon safe while breastfeeding?

Summary of use during breastfeeding

Data from one patient indicates that ramelteon and its principle active metabolite have low levels in milk. Monitor the infant for drowsiness and adequate feeding, especially while nursing a newborn or preterm infant. Until more data become available an alternate drug may be preferred.

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

• Zaleplon
• Zolpidem