Not Recommended

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Risk Summary: Interim data from a prospective observational study looking at pregnancy and fetal outcomes associated with modafinil/armodafinil exposure from 6 weeks prior to conception and/or during pregnancy, has shown an overall rate of major congenital malformations to be approximately 15% compared to 3% in the general population; based on animal data, this drug may cause fetal harm.

Comments:
-Women of childbearing potential should be informed about the risks of using this drug during pregnancy.
-Women of childbearing potential should use effective contraception during treatment and for 2 months after stopping this drug.
-This drug may reduce the effectiveness of oral contraceptives, alternative or additional methods of contraception are required.

In animal studies in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures. Intrauterine growth restriction and spontaneous abortion have been reported with modafinil (a mixture of R-and S-modafinil) and armodafinil (the R-enantiomer of modafinil). Use of this drug during pregnancy is associated with congenital malformations including congenital heart defects, hypospadias, and orofacial clefts. An interim data analysis from the US Nuvigil (armodafinil) and Provigil (modafinil) Pregnancy Registry revealed of 78 prospective pregnancy cases, 61 live births were recorded, of which 9 had a major congenital anomaly. There are no controlled data in human pregnancy.

Pregnancy Registry: Healthcare providers are encouraged to register pregnant patients or pregnant women may enroll themselves: 1-866-404-4106

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

AU, UK: This drug should not be used during breastfeeding.
US: Caution is recommended.

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

Comments:
-In an animal study, drug concentration in milk was about 11.5 times higher than in plasma.
-The effects in the nursing infant are unknown.

See references