Is Nitrazepam 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 Nitrazepam. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Nitrazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration. It is excreted into breastmilk in small amounts. Because of its long half-life of about 30 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. If nitrazepam is used, monitor the infant for sedation, poor feeding and poor weight gain.
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
Maternal Levels. Five women received radioactively tagged nitrazepam 5 mg at 8 pm daily for 5 days. Milk samples were collected daily at 9 am and 5:45 pm. The authors estimated that an infant would receive about 5 to 10 mcg/L of nitrazepam per 100 mL of milk ingested.[1]
Ten mothers were given oral nitrazepam 5 mg for sleep in the first 5 nights postpartum if they requested it. One of the mothers did not produce enough milk to measure the drug. Of the remaining 9 mothers, between 4 and 8 took the medication nightly. Milk nitrazepam levels were measured at 6 am the following day, 6 to 8 hours after the previous dose. Average milk concentrations were about 8.4 mcg/L on day 1 and 14 mcg/L on day 5. The authors calculated that a breastfed infant would receive an average of between 1 and 1.5 mcg per 100 mL of milk ingested or a maximum of 2 mcg per 100 mL.[2] This is equivalent to about 2.6% of the maternal weight-adjusted dose.[3]
Infant Levels. One mother took nitrazepam 5 mg orally at bedtime for sleep nightly for 5 nights while breastfeeding her newborn. On day 5 of life, nitrazepam was undetectable (<2.8 mcg/L) in the infant's serum.[2]
Alternatives LactMed lists
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Nitrazepam” (LM1086). 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.