Is Etizolam safe while breastfeeding?

Summary of use during breastfeeding

Etizolam is not approved for marketing in the United States by the U.S. Food and Drug Administration. Very little information is available on the passage of etizolam into milk. An alternate drug is preferred, especially while nursing a newborn or preterm infant. If etizolam is used, monitor the infant for sedation, poor feeding and poor weight gain.

Effects on the breastfed infant

A woman took etizolam 1 mg and trazodone 50 mg once daily for 3 months postpartum. Her infant was over 50% breastfed and demonstrated no adverse reactions at the 1- and 3-month checkups.[2]

Effects on milk supply

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

Levels in milk

Maternal Levels. One woman who was taking oral etizolam 1 mg daily donated milk samples between 3 and 6 days postpartum at 1 hour after a dose at the estimated peak serum concentration and just before a dose. She had a 1-hour milk level of 0.77 mcg/L and a trough milk level of 0.9 mcg/L.[1]

A woman took etizolam 1 mg and trazodone 50 mg once daily for 3 months postpartum. A milk sample on day 7 postpartum at 11.5 hours after the dose contained 1 mcg/L of etizolam. Four milk samples taken on day 35 postpartum from 15.5 to 25 hours after the dose contained etizolam in concentrations from 0.41 mcg/L to 0.2 mcg/L, respectively. On day 36 postpartum, milk samples at 6.5 and 13.5 hours after the dose contained 0.67 and 0.39 mcg/L of etizolam. The authors estimated that the maximum dose the infant would receive in milk was 0.15 mcg/kg daily which corresponds to 0.95% of the maternal weight-adjusted dosage.[2]

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

Alternatives LactMed lists

• Lorazepam
• Oxazepam
• Temazepam