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Can you take ramelteon while breastfeeding?

By the pharmaranks editorial teamReviewed against the NIH/NLM Drugs and Lactation Database (LactMed) sourcesUpdated Apr 18, 2022How we research

What LactMed says

The National Library of Medicine’s own summary, quoted in full. We do not write a verdict of our own on this question, and we do not compress theirs into a label.

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.

Quoted from Ramelteon — Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, revised April 18, 2022.

What LactMed would consider instead

LactMed ends this record by naming the drugs it would consider in place of ramelteon. Whether any of them fits depends on what you are treating — this is the database’s list, not a recommendation from us.

How much ramelteon gets into breastmilk

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.

Infant Levels. Relevant published information was not found as of the revision date.

What has been seen in breastfed infants

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. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Frequently asked questions

Can you take ramelteon while breastfeeding?

Data from one patient indicates that ramelteon and its principle active metabolite have low levels in milk. The full record is quoted on this page, and the decision is one to make with the person who prescribed it — LactMed itself states it is not a substitute for professional judgement.

What can I take instead of ramelteon while breastfeeding?

LactMed lists Zaleplon, Zolpidem as alternate drugs to consider. That is the database's own list for this drug — whether any of them suits you depends on what you are treating.

Does ramelteon pass into breastmilk?

LactMed's measured drug levels for ramelteon are quoted in full on this page, under "How much gets into breastmilk".

Do I need to pump and dump after taking ramelteon?

LactMed does not frame its records that way — it reports measured drug levels in milk and what has been observed in breastfed infants, which is what this page quotes. "Pump and dump" advice for a specific drug and dose should come from your clinician or a pharmacist, not from a general rule.

More on ramelteon

LactMed states that the information it presents is not a substitute for professional judgement, and that you should consult your healthcare provider for breastfeeding advice related to your particular situation. Nothing on this page is medical advice.