Summary of Use during Lactation

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 treated with oral administration of 30 mg of zuranolone daily for 5 days. The daily infant dose was approximately 0.0013 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

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Brexanolone, Nortriptyline, Paroxetine, Sertraline

Substance Name

Zuranolone

CAS Registry Number

1632051-40-1

Drug Class

Breast Feeding

Lactation

Milk, Human

Antidepressants

Antidepressive Agents

GABA Agents

Hormones

Progesterone Congeners