Is Modafinil (provigil) safe to use during pregnancy?

From the Guidelines

Modafinil (Provigil) is not recommended for use during pregnancy due to potential fetal harm and insufficient human data to determine risk. The medication is classified as a pregnancy category C medication, meaning that animal studies have shown adverse effects on the fetus, and there are no adequate well-controlled studies in humans 1. Limited human data, including a 2018 annual report of the ongoing armodafinil/modafinil pregnancy registry in the United States, suggests potential risks, including a higher rate of major congenital anomalies and other adverse reactions in children exposed to the drug in utero 1.

Key Considerations

• Modafinil may reduce the effectiveness of oral contraception, which is important to know if you're using birth control while taking this medication 1.
• The balance of risks and harms is likely different for pregnant and breastfeeding women, and the benefits of modafinil use in these populations may not outweigh the risks 1.
• If you are pregnant or planning to become pregnant while taking modafinil, you should consult with your healthcare provider immediately to discuss alternative treatments.
• For women who require treatment for conditions like narcolepsy or shift work sleep disorder during pregnancy, your doctor may recommend safer alternatives or carefully weigh the benefits versus risks in your specific situation.

Important Warnings

• Always inform all your healthcare providers about your pregnancy status before starting or continuing any medication.
• Be aware of the potential for modafinil to cause fetal harm and the importance of discussing alternative treatments with your healthcare provider if you are pregnant or planning to become pregnant.

From the FDA Drug Label

There are no adequate and well-controlled studies of modafinil in pregnant women. Intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of R-and S-modafinil) and armodafinil (the R-enantiomer of modafinil) Modafinil tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Modafinil use during pregnancy is not recommended unless the potential benefit outweighs the potential risk to the fetus. The drug label reports cases of intrauterine growth restriction and spontaneous abortion associated with modafinil use, although it is unknown if these cases are drug-related.

• Key points:
  • No adequate and well-controlled studies in pregnant women
  • Potential risk to the fetus
  • Use only if potential benefit justifies the risk 2

From the Research

Modafinil and Pregnancy

• The safety of modafinil during pregnancy is a concern, with some studies suggesting potential risks to the fetus 3.
• A study published in 2024 found that modafinil exposure during pregnancy was associated with a tendency towards lower birth weight and reduced neonatal head circumference, although the results were considered preliminary 3.
• Another study from 2013 reported that three women became pregnant while taking modafinil and oral contraceptives, highlighting the importance of effective contraceptive measures for women taking modafinil 4.
• A 2021 cohort study used data from the US Provigil/Nuvigil Pregnancy Registry to assess fetal outcomes after exposure to modafinil and armodafinil during pregnancy, but the specific findings are not detailed in the available text 5.
• The use of modafinil during pregnancy is generally not recommended until further studies can provide more definitive conclusions about its safety 3.

Potential Risks and Considerations

• Modafinil may reduce the efficacy of low-dose oral contraceptives, increasing the risk of unplanned pregnancy 6.
• The drug has been associated with various adverse events, including headache, nausea, nervousness, and hypertension, although the incidence of these events in pregnant women is not well characterized 6, 7.
• The potential for modafinil to induce certain types of events in individual patients, including cardiac and psychiatric events, has been noted in some studies 4.

Clinical Guidance

• Women of childbearing potential should be advised to use effective contraceptive measures when taking modafinil, and the drug should be avoided during pregnancy unless absolutely necessary 4, 3.
• Healthcare providers should carefully weigh the potential benefits and risks of modafinil use in pregnant women and consider alternative treatments when possible 3.