09 Sep

Is Modafinil Safe to Take During Pregnancy

Don’t Take Modafinil during Pregnancy

Recently this blog tackled several important questions about reproductive health: Premature Ejaculation and Women’s hormonal birth control. We add to that series today with an investigation into modafinil’s effects on pregnant women. Based on the FDA’s classification of modafinil, this blog and most medical professionals would recommend you do NOT take modafinil during pregnancy.

How the FDA classifies medicines for pregnancy

The US FDA is the best source for a drug’s safety during pregnancy since part of the approvals process for any medication is to provide at least some basic evaluation of the effects on fetuses and breastmilk. Based on these results, the FDA categorizes all medicines into 5 groups: A, B, C, D, and X. It works like this:

  • Category A: Proven completely safe
  • Category B: No evidence to suggest any risk, but not proven safe
  • Category C: Animal studies show adverse effects, but no human trial evidence
  • Category D: Evidence of adverse effects on human fetuses
  • Category X: Proven to produce extremely negative effects.

In all of these categories the common thread is how much evidence exists to support the data. Category B, for instance, could be just as safe as A, but in order to move into the A group studies must consistently demonstrate no negative impact whatsoever. Likewise, harm to animals is good enough for category C, but D requires evidence of effects on humans.

Why does the scale jump from D to the rather terrifying X rating? It all comes down to safety.

In categories C and D, there is evidence of negative effects, but the benefits of the medicine may outweigh those negative effects on the fetus. For instance, many anti-anxiety medications are found in categories C and D. A doctor might argue that it’s better for the mother to take these pills and risk some minor harm to the baby, rather than not take them and perhaps suffer an anxiety attack that leads to a miscarriage.

But Category X is reserved for substances that will always harm the fetus more than it helps the mother, for instance many of the cholesterol-lowering drugs are in this group. A little extra cholesterol probably won’t kill a young mother, but would absolutely kill the baby.

Modafinil’s FDA classification for pregnancy

Modafinil is category C, meaning that no proof of human damage exists, but there is reason to be concerned. It’s recommended that women do not take modafinil while they are pregnant. Considering the risk-reward calculation, it’s almost impossible to imagine a scenario where modafinil was absolutely necessary. While you might want to have some extra energy to help you carry that baby around inside of you, don’t take modafinil if you’re pregnant.

What about breastfeeding?

Modafinil is also excreted through breastmilk, and while there are currently no studies that show what happens to babies who are exposed to modafinil, doctors agree that it’s best to avoid taking modafinil while you breastfeed.

Modafinil has a potent effect on the brain, and in a brain that is still forming and developing, it’s unclear if this effect could have a negative impact down the line. Modafinil has been approved for young children, but not babies. People want babies to sleep, not stay awake. So given the lack of a practical application, there is no research.

So listen up pregnant women, stay away from modafinil!

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