Amisulpride use while Breastfeeding
Amisulpride Levels and Effects while Breastfeeding
Summary of Use during Lactation
Amisulpride is not approved for marketing in the United States by the US Food and Drug Administration, but is available in other countries. Because there is little published experience with amisulpride during breastfeeding and excretion into breastmilk is higher than with other pharmacologically similar drugs, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Maternal Levels. A nursing mother was taking oral amisulpride 100 mg twice daily at 8:00 am and 12:30 pm, and desvenlafaxine 250 mg daily. Eight breastmilk samples were obtained over a 24-hour period with a breast pump. The average breastmilk concentration was 1.2 mg/L which equated to an infant dose of 183 mcg/kg daily or 6.1% of the maternal weight-adjusted dosage.
A woman who was 13 months postpartum had been taking amisulpride 400 mg (5 mg/kg) once daily for 9 days. Eight milk samples were obtained over a 24-hour period and consisted of about 50% foremilk and 50% hindmilk. The average breastmilk concentration was 1.6 mg/L which would provide a fully breastfed infant a dose of 534 mcg/kg daily or 10.7% of the maternal weight-adjusted dosage.
Infant Levels. A nursing mother had been taking oral amisulpride 100 mg twice daily at 8:00 am and 12:30 pm, and desvenlafaxine 250 mg daily for 12.6 weeks. Her partially breastfed infant was 5 months old. The infant's serum amisulpride concentration 3.1 hours after the mother's daily dose was 4 mcg/L or 3.9% of the maternal serum concentration.
Effects in Breastfed Infants
A 13-month-old infant was partially breastfed by a mother who was taking amisulpride 400 mg, fluvoxamine 200 mg, and azathioprine 150 mg daily, and was using nicotine chewing gum for smoking cessation. The mother had been taking amisulpride for 9 days; the duration of the other medications was not stated. A pediatric examination found the infant to be developing well.
A woman with long-standing schizophrenia was treated with amisulpride 400 mg and haloperidol 5 mg daily throughout most of her pregnancy and during breastfeeding (extent not stated). Follow-up of the breastfed infant for 13 months by a pediatrician found no adverse effects and normal development of the infant.
Effects on Lactation and Breastmilk
Amisulpride increases serum prolactin and has caused galactorrhea in at least 2 women. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Alternate Drugs to Consider
1. Ilett KF, Watt F, Hackett LP et al. Assessment of infant dose through milk in a lactating woman taking amisulpride and desvenlafaxine for treatment-resistant depression. Ther Drug Monit. 2010;32:704-7. PMID: 20926994
2. Teoh S, Ilett KF, Hackett LP, Koha R. Estimation of rac-amisulpride transfer into milk and of infant dose via milk during its use in a lactating woman with bipolar disorder and schizophrenia. Breastfeed Med. 2011;6:85-8. PMID: 20925494
3. Uguz F. Breastfed infants exposed to combined antipsychotics: Two case reports. Am J Ther. 2015. PMID: 26539905
4. Kopecek M, Bares M, Svarc J et al. Hyperprolactinemia after low dose of amisulpride. Neuro Endocrinol Lett. 2004;25:419-22. PMID: 15665803
5. Paparrigopoulos T, Liappas J, Tzavellas E et al. Amisulpride-induced hyperprolactinemia is reversible following discontinuation. Prog Neuropsychopharmacol Biol Psychiatry. 2007;31:92-6. PMID: 16938372
6. Bushe C, Shaw M. Prevalence of hyperprolactinaemia in a naturalistic cohort of schizophrenia and bipolar outpatients during treatment with typical and atypical antipsychotics. J Psychopharmacol. 2007;21:768-73. PMID: 17606473
7. Mendhekar D, Lohia D. Amisulpride and galactorrhoea: delayed or withdrawal? World J Biol Psychiatry. 2009;10 (4 Pt 3):1041-2. PMID: 19006011
8. Ruzic K, Grahovac T, Graovac M et al. Hyperprolactinaemia with amisulpride. Psychiatr Danub. 2011;23:92-4. PMID: 21448106
CAS Registry Number
LactMed Record Number
Last Revision Date
Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.