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Lemborexant Pregnancy and Breastfeeding Warnings

Lemborexant is also known as: Dayvigo

Medically reviewed by Drugs.com. Last updated on May 27, 2020.

Lemborexant Pregnancy Warnings

In animal studies, oral administration of this drug to pregnant rats and rabbits during the period of organogenesis caused toxicities only at high multiples of the human exposure at the maximum recommended human dose.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-888-274-2378.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no available data on this drug's use in pregnant women to evaluate risks of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Comments:
-A pregnancy exposure registry is available.

See references

Lemborexant Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
- Infants exposed to this drug through breastmilk should be monitored for excessive sedation.

This drug and its metabolites are present in the milk of lactating rats, so it is likely that it will be present in human milk.

See references

References for pregnancy information

  1. "Product Information. Dayvigo (lemborexant)." Eisai Inc, Woodcliff Lake, NJ.

References for breastfeeding information

  1. "Product Information. Dayvigo (lemborexant)." Eisai Inc, Woodcliff Lake, NJ.

Further information

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