Is Agomelatine compatible with breastfeeding? Do we have alternatives for Agomelatine?


June 10, 2018 (Low Risk)

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Side effects are usually mild or moderate, although hepatic damage has been reported in 4% of users, leading it to be withdrawn from sale in several countries (Carvalho 2016).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


Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

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

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.


  • Αγομελατίνη (Greek)
  • أغوميلاتين (Arabic)
  • Агомелатин (Cyrillic)
  • 阿戈美拉汀 (Chinese)
  • アゴメラチン (Japanese)
  • Agomélatine (French)
  • C15 H17 NO2 (Molecular formula)
  • N-[2-(7-Methoxy-1-naphthyl)ethyl]acetamide (Chemical name)
  • N06AX22 (ATC Code/s)


  1. EMA. Agomelatine. Drug Summary. 2917Abstract Full text (link to original source) Full text (in our servers)
  2. EMA. Agomelatina. Ficha técnica. 2017 Full text (link to original source) Full text (in our servers)
  3. Carvalho AF, Sharma MS, Brunoni AR, Vieta E, Fava GA. The Safety, Tolerability and Risks Associated with the Use of Newer Generation Antidepressant Drugs: A Critical Review of the Literature. Psychother Psychosom. 2016Abstract
  4. Schmidt FM, Lichtblau N, Uribe MM, Kirchherr H, Himmerich H. Agomelatine in breast milk. Int J Neuropsychopharmacol. 2013Abstract Full text (link to original source) Full text (in our servers)