Suvorexant Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on Mar 17, 2023.
Suvorexant is also known as: Belsomra
Suvorexant Pregnancy Warnings
Suvorexant in pregnant rats at exposures approximately 25 times that in humans resulted in decreased fetal body weight. Suvorexant in pregnant rabbits at exposures approximately 40 times that in humans resulted in premature sacrifice of pregnant animals. There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Suvorexant Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
The effects in the nursing infant are unknown.
Suvorexant and a hydroxyl-suvorexant metabolite were excreted in rat milk at levels higher (9 and 1.5 times, respectively) than that in maternal plasma.
See also
References for pregnancy information
- "Product Information. Belsomra (suvorexant)." Merck & Co., Inc (2014):
References for breastfeeding information
- "Product Information. Belsomra (suvorexant)." Merck & Co., Inc (2014):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.