Last update June 10, 2018


Low Risk

Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

A melatonin receptor agonist and serotonin antagonist. It increases the release of norepinephrine and dopamine in the frontal cortex (EMA 2017).
Indicated in episodes of major depression.
Administered orally once a day at bedtime for at least 6 months. Stopping the drug does not require a progressive decrease in the dose.

Its pharmacokinetic data (low oral bioavailability, high protein binding and short life) explain the very small transfer to milk observed.
In a mother who took 25 mg daily, milk concentration reached 2 micrograms (mcg)/L 2 hours after taking it and was undetectable (<0.1 mcg/L) after 4 hours (Schmidt 2013).

You can minimize the risk even more, by waiting for at least 4 hours to breastfeed.

Side effects are usually mild or moderate, although hepatic damage has been reported in 4% of users, leading it to be withdrawn from sale in several countries (Carvalho 2016).

Its dopaminergic effect is anti-prolactin (dopamine inhibits prolactin secretion) and may decrease milk production during the first weeks after delivery. When breastfeeding is well established, prolactin levels are not correlated with milk production.

If you cannot use one of the proposed alternatives, milk production must be monitored.


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.

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

Agomelatine in other languages or writings:


Agomelatine belongs to this group or family:


Main tradenames from several countries containing Agomelatine in its composition:


Variable Value Unit
Oral Bioavail. 5 %
Molecular weight 243 daltons
Protein Binding 95 %
VD 0.5 l/Kg
Tmax 1 - 2 hours
1 - 2 hours
Theoretical Dose 0.00026 - 0.0003 mg/Kg/d
Relative Dose 0.06 - 0.07 %


  1. EMA. Agomelatina. Ficha técnica. 2017 Full text (link to original source) Full text (in our servers)
  2. EMA. Agomelatine. Drug Summary. 2017 Abstract Full text (link to original source) Full text (in our servers)
  3. Schmidt FM, Lichtblau N, Uribe MM, Kirchherr H, Himmerich H. Agomelatine in breast milk. Int J Neuropsychopharmacol. 2013 Abstract Full text (link to original source) Full text (in our servers)

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