Skip to main content

Flurazepam Pregnancy and Breastfeeding Warnings

Brand names: Dalmane

Medically reviewed by Drugs.com. Last updated on Jul 30, 2025.

Flurazepam Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk. Neonates born to mothers exposed to benzodiazepines late in pregnancy have been reported to experience sedation and/or withdrawal symptoms.

Comments:
-A pregnancy exposure registry is available.
-The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.
-Benzodiazepines may cause fetal harm when administered during pregnancy.
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.

Several studies have suggested an increased risk of congenital malformations associated with the use of minor tranquilizers (i.e., chlordiazepoxide, diazepam, meprobamate) during the first trimester of pregnancy. There are no adequate studies in pregnant women.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients. For more information: https://womensmentalhealth.org/pregnancyregistry/.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Flurazepam Breastfeeding Warnings

UK: Use is not recommended.

US: The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

See references

Does Flurazepam interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

See also

References for pregnancy information

  1. (2001) "Product Information. Dalmane (flurazepam)." Roche Laboratories
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. (2023) "Product Information. Flurazepam Hydrochloride (flurazepam)." Chartwell RX, LLC.

References for breastfeeding information

  1. (2001) "Product Information. Dalmane (flurazepam)." Roche Laboratories
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer