Mianserin use while Breastfeeding
Mianserin Levels and Effects while Breastfeeding
Summary of Use during Lactation
Mianserin is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Limited information indicates that maternal doses up to 60 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Until more data are available, mianserin should be used with careful monitoring during breastfeeding.
Maternal Levels. One woman with major depression was taking mianserin 60 mg daily for 9 days. Another woman was taking mianserin 40 mg daily for 14 days. A single milk sample was collected 15 hours after the previous dose in each woman. The first woman had breastmilk levels of 80 mcg/L of mianserin and 10 mcg/L of desmethylmianserin. The second woman had breastmilk levels of 20 mcg/L of mianserin and 20 mcg/L of desmethylmianserin. The authors estimated that the dosage was 0.012 mg/kg/day for the first infant, and 0.003 mg/kg/day for the second. These correspond to 1.4% and 0.5% of their respective mothers' weight-adjusted maternal dosages.
Infant Levels. One woman with major depression was taking mianserin 60 mg daily for 9 days. Her 3-month-old breastfed (extent not stated) infant's plasma had no detectable (<10 mcg/L) mianserin or desmethylmianserin. Another 5-month-old breastfed (extent not stated) infant whose mother was taking mianserin 40 mg daily for 14 days had mianserin 12 mcg/L and desmethylmianserin 14 mcg/L detected in his urine.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
An observational study looked at outcomes of 2859 women who took an antidepressant during the 2 years prior to pregnancy. Compared to women who did not take an antidepressant during pregnancy, mothers who took an antidepressant during all 3 trimesters of pregnancy were 30% less likely to be breastfeeding upon hospital discharge. Mothers who took an antidepressant only during the third trimester were 75% less likely to be breastfeeding at discharge. Those who took an antidepressant only during the first and second trimesters did not have a reduced likelihood of breastfeeding at discharge. The antidepressants used by the mothers were not specified.
1. Buist A, Norman TR, Dennerstein L. Mianserin in breast milk. Br J Clin Pharmacol. 1993;36:133-4. Letter. PMID: 8398582
2. Venkatesh KK, Castro VM, Perlis RH et al. Impact of antidepressant treatment during pregnancy on obstetric outcomes among women previously treated for depression. Am J Obstet Gynecol. 2017;216:S466-S467.
CAS Registry Number
Antidepressive Agents, Second-Generation
LactMed Record Number
Last Revision Date
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