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Suvorexant Pregnancy and Breastfeeding Warnings

Brand names: Belsomra

Medically reviewed by Drugs.com. Last updated on Mar 17, 2025.

Suvorexant Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

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.

See references

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 references

See also

References for pregnancy information

  1. (2014) "Product Information. Belsomra (suvorexant)." Merck & Co., Inc

References for breastfeeding information

  1. (2014) "Product Information. Belsomra (suvorexant)." Merck & Co., Inc

Further information

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

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