Armodafinil Pregnancy and Breastfeeding Warnings

Armodafinil is also known as: Nuvigil

Armodafinil Pregnancy Warnings

Armodafinil has been assigned to pregnancy category C by the FDA. Animal studies (i.e., rats) have revealed evidence of developmental toxicity at clinically relevant doses. There are no controlled data in human pregnancy; however, armodafinil and modafinil have been associated with two cases of intrauterine growth retardation and one case of spontaneous abortion. Armodafinil is only recommended for use during pregnancy when benefit outweighs risk.

Oral administration (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in increased incidences of fetal visceral and skeletal variations and decreased fetal body weights. The effect of armodafinil on labor and delivery in humans is unknown.

Armodafinil Breastfeeding Warnings

There are no data on the excretion of armodafinil into human milk. The manufacturer recommends that caution be used when administering armodafinil to nursing women.

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