Summary of use during lactation
Bromazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration but is available in other countries. The death of a newborn infant breastfed by a mother who was apparently using bromazepam has been reported. If a mother of an older infant requires bromazepam, it is not a reason to discontinue breastfeeding; however, an alternate drug is preferred, especially while nursing a newborn, preterm or sick infant.
Drug levels in milk and infant serum
Maternal Levels. Relevant published information was not found as of the revision date. Infant Levels. Relevant published information was not found as of the revision date.
Effects in breastfed infants
A 4-week-old infant with a 5-day history of near-miss sudden infant death syndrome was brought to the emergency room with asystole and unresponsive pupils. Despite resuscitation, the infant died. The infant’s serum contained a plasma concentration of 0.38 mcg/mL of “diazepam equivalents” and the infant’s urine was positive for bromazepam. The mother appeared to have been taking sedatives over the last few days, while partially breastfeeding, because of nervousness and sleeplessness.[1] Bromazepam probably contributed to the infant’s death.[2]
Effects on lactation and breastmilk
Relevant published information was not found as of the revision date.
Alternative drugs to consider
(Anxiety) Lorazepam, Oxazepam, Temazepam
Source: Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, NCBI Bookshelf. Check LactMed for the most recent revision.
Medical disclaimer: This page is for qualified healthcare professionals and is a decision-support aid only. It does not replace clinical judgement, local protocols or product information. Verify every dose and threshold before use. See the full Medical Disclaimer.