From the Guidelines
Modafinil should be avoided during pregnancy due to significant risks to the developing fetus, as indicated by a higher rate of major congenital anomalies and other adverse reactions in children exposed to the drug in utero, as reported in a 2018 annual report of the ongoing armodafinil/modafinil pregnancy registry in the United States 1. This medication is classified as FDA pregnancy category C, indicating potential fetal harm based on animal studies and limited human data. The primary concerns include an increased risk of congenital malformations, particularly facial and cardiovascular defects, when used during pregnancy. There have been reports of spontaneous abortion and intrauterine growth restriction associated with modafinil use. Women of childbearing potential should use effective contraception while taking modafinil, as it can reduce the effectiveness of hormonal contraceptives. Some of the key points to consider when evaluating the risks of modafinil during pregnancy include:
- The potential for fetal harm based on animal studies and limited human data
- The increased risk of congenital malformations and other adverse reactions in children exposed to the drug in utero
- The need for effective contraception in women of childbearing potential taking modafinil
- The potential for modafinil to reduce the effectiveness of hormonal contraceptives If you are pregnant or planning pregnancy, consult your healthcare provider immediately about discontinuing modafinil and exploring safer alternatives for treating conditions like narcolepsy, shift work sleep disorder, or obstructive sleep apnea. The risks occur because modafinil crosses the placental barrier and may interfere with normal fetal development through its effects on neurotransmitters and cellular processes. Any woman who becomes pregnant while taking modafinil should inform her healthcare provider right away to discuss the risks and appropriate management, as supported by the American Academy of Sleep Medicine clinical practice guidelines 1.
From the FDA Drug Label
8 USE IN SPECIFIC POPULATIONS
- 1 Pregnancy Pregnancy Category C 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) Although the pharmacology of modafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class. Certain of these drugs have been associated with intrauterine growth restriction and spontaneous abortions. Whether the cases reported with modafinil are drug-related is unknown In studies of modafinil and armodafinil conducted in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures. Modafinil tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
The pregnancy risks for modafinil include:
- Intrauterine growth restriction
- Spontaneous abortion
- Developmental toxicity observed in animal studies at clinically relevant plasma exposures The use of modafinil during pregnancy is categorized as Pregnancy Category C, indicating that the potential benefit must justify the potential risk to the fetus 2.
From the Research
Pregnancy Risks for Modafinil
- The use of modafinil during pregnancy has been associated with potential risks, including major congenital anomalies and impaired fetal growth 3, 4.
- A study found that modafinil exposure during pregnancy was not associated with an increased risk of major congenital anomalies, but was associated with lower birth weight and reduced neonatal head circumference 3.
- Another study suggested that modafinil may have a potential teratogenic impact, but the evidence is conflicting and more research is needed to clarify the risks 4.
- Modafinil has been shown to be well tolerated in patients with narcolepsy, but its use during pregnancy is not recommended due to the potential risks 5, 6.
- A case-control study found that women with narcolepsy with cataplexy who took modafinil during pregnancy had similar pregnancy outcomes to controls, but had a higher prevalence of gestational diabetes 7.
Key Findings
- Modafinil exposure during pregnancy may be associated with lower birth weight and reduced neonatal head circumference 3.
- The use of modafinil during pregnancy is not recommended due to the potential risks, but more research is needed to clarify the risks 4.
- Women with narcolepsy with cataplexy who take modafinil during pregnancy may have a higher prevalence of gestational diabetes 7.