Modafinil Pregnancy and Breastfeeding Warnings

Brand names: Provigil

Modafinil Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.

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

Comments:
-Women of childbearing potential should use effective contraception during therapy and for up to 2 months after treatment discontinuation.
-This drug may reduce the effectiveness of hormonal contraception; thus, counsel patients on the potentially increased risk of pregnancy with concomitant use of steroidal contraceptives such as the pill, injectables, and hormonal intrauterine devices.
-Alternative (non-steroidal/non-hormonal) methods of contraception are recommended.
-According to some authorities: Females of reproductive potential should have a negative pregnancy test within a week prior to starting treatment.

Animal studies have revealed evidence of developmental toxicity at clinically relevant plasma exposures. Administration of this drug to pregnant rats during the period of organogenesis demonstrated hydronephrosis, skeletal variations, and increased resorptions. Embryotoxicity was not observed in rabbits receiving oral doses throughout organogenesis. However, animal studies were not conducted at adequately high doses or according to guidelines that provide a comprehensive evaluation of embryotoxicity or potentially toxic effects. The highest no-effect dose for developmental toxicity in animals was at or below the human exposure at the recommended dose.

In humans, 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 has been associated with congenital malformations including cardiac anomalies and microcephaly. Data suggest the rate of malformations associated with exposure is about 17.3%, versus 3% in the general population. There are no well-controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Modafinil Breastfeeding Warnings

Until more data become available, caution is recommended, or an alternate drug may be preferred.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes (based on case reports in nursing mothers)

Comments:
-Careful infant monitoring is recommended if this drug is used during breastfeeding.
-Limited data suggest that levels of this drug in breast milk and infant serum are very low.
-No adverse effects in breastfed infants or on lactation/breastmilk were noted across case studies.

See references

Further information

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