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Mirtazapine is a tetracyclic antidepressant with sedative action, analog of mianserin, used in the treatment of major depression and, off-label, to treat insomnia and increase appetite. Oral administration in one or two daily doses.

It is excreted into breast milk in a clinically non-significant amount. ^{(Tonn 2009, Klier 2007, Kristensen 2007, Aichhorn 2004)}

Plasma level of breastfed infants from treated mothers with Mirtazapine are usually undetectable or very low ^{(Klier 2007, Kristensen 2007, Aichhorn 2004)}, with some exceptions. ^{(Tonn 2009)}

Not significant clinically based side-effects in the infants both at short and long-term have been observed. ^{(Uguz 2019, Tonn 2009, Klier 2007, Kristensen 2007, Aichhorn 2004)} 

Isolated cases of galactorrhea ^{(Schroeder 2013, Lynch 2004)} and decreased prolactin ^{(Schüle 2002)} have been reported.

Expert authors consider the use of this medication possible during breastfeeding. ^{(Hale, LactMed, Uguz 2021, Schaefer 2015, Berle 2011, Davanzo 2011, Patil 2011, Lanza 2009)}

The poor extrauterine adaptation that may appear in neonates just after birth when the pregnant woman has been treated with selective reuptake-inhibitors of Serotonin like Venlafaxine or Mirtazapine, is seen to be mild if the baby is breastfed. ^{(Smit 2015, Kieviet 2013, Hale 2010)}

It is not recommended to share a bed with the baby if this drug is being taken. ^{(UNICEF 2018, 2017, 2014 and 2013, Landa 2012, ABM 2008, UNICEF 2006)}

Due to the sedative action on the mother and because there is less published experience than with other antidepressant drugs, known safer alternatives might be preferable, especially during the neonatal period and in the event of prematurity.

See below the information of these related products:

• Maternal Depression (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)
• Mianserin Hydrochloride (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)