Last update June 25, 2022


Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

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.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Ramelteon in other languages or writings:


Ramelteon belongs to this group or family:


Main tradenames from several countries containing Ramelteon in its composition:


Variable Value Unit
Oral Bioavail. 1.8 %
Molecular weight 259 daltons
Protein Binding 82 %
VD 1.05 l/Kg
pKa 15.8 -
Tmax 0.75 (0.5 - 1.5) hours
1 - 2.6 hours
M/P ratio 1 -
Theoretical Dose 0.00024 mg/Kg/d
Relative Dose 0.24 %


  1. Saito J, Tachibana Y, Sano Wada Y, Kawasaki H, Miura Y, Oho M, Aoyagi K, Yakuwa N, Suzuki T, Yamatani A, Sago H, Murashima A. Presence of Hypnotics in the Cord Blood and Breast Milk, with No Adverse Effects in the Infant: A Case Report. Breastfeed Med. 2022 Apr;17(4):349-352. Consulted on April 11, 2022 Abstract
  2. Takeda. Ramelteon (Rozerem) Drug Summary. 2010 Full text (in our servers)
  3. 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 Mar;24(2):103-11. Abstract

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