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Remimazolam Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Oct 20, 2021.

Remimazolam is also known as: Byfavo

Remimazolam Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.

-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Neonates exposed to this drug during pregnancy or in labor should be monitored for signs/symptoms of sedation and respiratory depression (irregularities in fetal heart rate, hypotonia, poor sucking, hypothermia, and moderate respiratory depression.
-If used during pregnancy, monitor the newborn for withdrawal symptoms during the postnatal period.

Animal studies have revealed evidence of reduced fetal weight at doses 4 times the maximum human dose. Primates have revealed a potential risk of cognitive defects (indicated by neuronal apoptosis) in maternal benzodiazepine use corresponding to the third trimester (especially in procedures lasting longer than 3 hours). There are no controlled data in human pregnancy.

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

Remimazolam Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

-The effects in the nursing infant and on milk production during lactation are unknown.
-Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines.
-Infants of lactating mothers should be observed for pharmacological effects (including feeding problems, respiratory depression, and/or sedation).
-Some experts state that lactating patients may minimize infant drug exposure by interrupting breastfeeding and pumping and discarding breastmilk during and for 5 hours after administration.

See references

References for pregnancy information

  1. "Product Information. Byfavo (remimazolam)." Acacia Pharma, Inc, Indianapolis, IN.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Byfavo (remimazolam)." Acacia Pharma, Inc, Indianapolis, IN.

Further information

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