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.
Drug Levels
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.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
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.
Saito J, Tachibana Y, Sano Wada Y, et al. Presence of hypnotics in the cord blood and breast milk, with no adverse effects in the infant: A case report. Breastfeed Med. 2022;17:349–52. [PubMed: 34935466]
2.
Richardson G, Wang-Weigand S. Effects of long-term exposure to ramelteon, a melatonin receptor agonist, on endocrine function in adults with chronic insomnia. Hum Psychopharmacol. 2009;24:103–11. [PubMed: 19090503]
Substance Identification
Substance Name
Ramelteon
CAS Registry Number
196597-26-9
Drug Class
Breast Feeding
Lactation
Milk, Human
Central Nervous System Depressants
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