Published: 6 December 2019

Publications

Do not use modafinil in pregnant patients or those who may become pregnant

Prescriber Update 40(4): 74–75
December 2019

Modafinil is indicated to improve wakefulness in people with excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnoea/hypopnoea syndrome (OSAHS), or shift work sleep disorder (SWSD)¹.

Modafinil is contraindicated during pregnancy

This contraindication was recently updated and extended to include patients who may become pregnant.

The contraindication was updated because modafinil is suspected to cause congenital malformations when administered during pregnancy. This suspicion comes from limited human experience from a pregnancy registry and spontaneous reporting. There are no well-controlled trials with modafinil in pregnant women.

Women of childbearing potential must use effective contraception

Modafinil may reduce the effectiveness of oral contraception due to enzyme induction. Alternative or concomitant methods of contraception are recommended during treatment with modafinil and for two months after stopping treatment. The data sheet is being updated with this information.

Refer to the data sheet for full prescribing information.

Reference

1. Teva Pharma New Zealand Ltd. 2019. Modavigil New Zealand Consumer Medicine Information September 2019. URL: www.medsafe.govt.nz/Consumers/CMI/m/modavigil.pdf (accessed 15 October 2019).