Belsomra 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
See references
Belsomra 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
