Last update June 25, 2022
Very Low Risk
Ramelteon is a melatonin receptor agonist used to treat insomnia. Oral administration in one dose at bedtime.
It is excreted in breast milk in clinically insignificant amounts. (Saito 2022)
Although the exposure time was short, no problems were seen in the infant whose mother took it. (Saito 2022)
Although the total absorption of ramelteon is at least 84%, the absolute oral bioavailability is only 1.8% due to extensive first-pass metabolism (Takeda 2010). Furthermore, administration with a fatty meal decreases its absorption (Takeda 2010). Its very low oral bioavailability makes it difficult for it to pass to the infant plasma from ingested breast milk, except in premature infants and in the immediate neonatal period in which there may be greater intestinal permeability.
It may cause asymptomatic hyperprolactinemia. (Richardson2009)
Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable, especially during the neonatal period and in the event of prematurity.
Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.
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e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2012 of United States of America
Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM