Because of the low amounts of zuranolone in milk, it would not be expected to cause any adverse effects in breastfed infants. If zuranolone is required by the mother, it is not a reason to discontinue breastfeeding. Until more data are available, zuranolone should be used with careful infant monitoring for excessive sedation during breastfeeding, especially with higher dosages and in newborn and preterm infants.
Drug Levels
Maternal Levels. The manufacturer reports a study in 14 healthy lactating women who were 12 or more weeks postpartum and treated with oral administration of 30 mg of zuranolone daily for 5 days. The daily infant dose via milk was estimated to be 0.00124 mg/kg, resulting in a mean weight-adjusted relative infant dose of 0.357% compared to the maternal dose. Concentrations of zuranolone in breastmilk were below the level of quantification limit by 4 to 6 days after the last dose.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
The manufacturer reports a study in 14 healthy lactating women who were 12 or more weeks postpartum and treated with oral administration of 30 mg of zuranolone daily for 5 days. There was a mean decrease of 41.2 mL or 8.3% in milk volume collected at day 5 of treatment compared with baseline. However, this could be an artifact of the study design, because participants were told to stop breastfeeding and pump their milk during the study.
Disclaimer: 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.
