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This section is designed to inform professionals.

(Consumers, see Fact Sheet on Modafinil)

Available as Modavigil, Provigil.

Use in Pregnancy

Category C

There are no adequate and well-controlled trials with modafinil in pregnant women (1). Two cases of intrauterine growth retardation and one case of spontaneous abortion have been reported in association with armodafinil (R-enantiomer of modafinil) and modafinil (3). There is a case report of a death of a neonate with adverse events of neonatal respiratory distress and severe intrauterine growth retardation, after the mother was prescribed modafinil throughout pregnancy (2).

Embryotoxicity was observed in rats at clinically relevant doses (1).

Modafinil should be used during pregnancy only if the potential benefit outweighs the potential risk.

Use in Lactation

Category L3

Modafinil and/or its metabolites have been found in the milk of lactating rats. No developmental toxicity was noted postnatally in the offspring of rats given oral modafinil during late gestation and throughout lactation, but the maximum dose in these studies was less than human exposure at the maximum recommended dose (1).

It is not known whether modafinil or its metabolites are excreted in human milk (1). Serious skin rashes have been associated with modafinil use in pediatric patients(1).


(1) Medsafe. Modavigil Data Sheet. Last updated 23 April 2008. Retrieved from http://www.medsafe.govt.nz/profs/datasheet/m/modavigiltab.htm on 15 October 2008.

(2) Cephalon Inc. Briefing Document for Psychopharmacologic Drugs Advisory Committee Meeting. Meeting Date: 23 March 2006. Retrieved from http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4212b1-01-cephalon-background.pdf on 15 October 2008.

(3) RxList. Provigil (Modafinil): Warnings & Precautions. Retrieved from http://www.rxlist.com/cgi/generic/modafinil_wcp.htm on 15 October 2008.

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