Is Flunitrazepam safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Flunitrazepam. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Flunitrazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration. It is excreted into breastmilk and, because of its long half-life of about 20 hours, it may accumulate in the serum of breastfed infants with repeated doses. Other agents are preferred, especially while nursing a newborn or preterm infant.[1] If flunitrazepam is used long-term, monitor the infant for sedation, poor feeding and poor weight gain. After a single dose of flunitrazepam, as for sedation before a procedure, there is usually no need to wait to resume breastfeeding, although with a newborn or preterm infant, a cautious approach would be to wait a period of 6 to 8 hours before resuming nursing.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Flunitrazepam is metabolized to the active metabolite norflunitrazepam.
Maternal Levels. Five nursing mothers were given a single oral dose of flunitrazepam 2 mg (66 mcg/kg) at 8 pm. Milk samples were collected 11, 15 and 27 hours later. The average flunitrazepam concentrations in milk were 2 mcg/L at 11 hours after the dose, 1.7 mcg/L at 15 hours after the dose, and 0.6 mcg/L at 27 hours after the dose. Norflunitrazepam was not detectable (<0.2 mcg/L) in milk at any of these times.[2,3] From these data, it is estimated that a fully breastfed infant would receive about 1% of the maternal weight-adjusted dosage.[4]
Two women who were taking oral flunitrazepam donated milk samples between 3 and 6 days postpartum at 2 hours after a dose at the estimated peak serum concentration and just before a dose. One woman who was taking a dose of 1 mg daily had a 2-hour milk level of 2.48 mcg/L and a trough milk level of 0.524 mcg/L. The other woman was taking a dose of 2 mg daily. She had a 2-hour milk level of 4.09 mcg/L and a trough milk level of 1.48 mcg/L. Norflunitrazepam was not measured.[5]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
“No published information” means the studies do not exist yet — not that Flunitrazepam is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Flunitrazepam” (LM1085). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.