Summary of Use during Lactation

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.

Drug Levels

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.

Effects in Breastfed Infants

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 Lactation and Breastmilk

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

Alternate Drugs to Consider

Lorazepam, Oxazepam, Temazepam

References

1.

Nishimura A, Furugen A, Umazume T, et al. Benzodiazepine concentrations in the breast milk and plasma of nursing mothers: Estimation of relative infant dose. Breastfeed Med 2021;16:424-31. [PubMed: 33449825]

2.

Saito J, Ishii M, Mito A, et al. Etizolam levels in maternal serum, cord blood, and breast milk during pregnancy and lactation: A case report. Psychiatry Clin Neurosci 2021;75:211-2. [PubMed: 33733552]

Substance Name

Etizolam

CAS Registry Number

40054-69-1

Drug Class

Breast Feeding

Lactation

Milk, Human

Hypnotics and Sedatives

Anti-Anxiety Agents

Benzodiazepines