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Is Modafinil safe in pregnancy?

Modafinil is used for the treatment of narcolepsy. It may be prescribed to treat shift work sleep disorder or obstructive sleep apnea as well. Some people believe that Modafinil can provide cognitive benefits, and that’s an off-label use for it, although there’s not much evidence to support this. Modafinil side effects include anxiety, headache, nausea and sleep disturbances. Serious side effects can include hallucinations and allergic reactions. Modafinil is a schedule IV-controlled substance in the U.S. since there is a slight risk of addiction. It is similar to some other stimulant drugs that are addictive, but there are differences as well. Modafinil can have mild mood-lifting properties. However, despite this, there are quite a few reports of people misusing or becoming addicted to Modafinil.

Modafinil is primarily prescribed for the treatment of narcolepsy. Untreated narcolepsy while pregnant will make the woman gain more weight than what’s considered healthy. This will increase the risk of complications like impaired glucose metabolism and anemia. Despite these complications connected to narcolepsy, pregnant women are often very cautious about the medications they can take during this time. So, the question is can you take Modafinil while pregnant? The answer can be confusing for pregnant women, as same is the case with so many other medications. Modafinil may be safe during pregnancy, but it can also not be.

The FDA categorizes medicines and other substances based on their perceived safety or risks during pregnancy. The category determinations are based on available research on both animal and human controlled studies. Few controlled human studies involves the observation of the effects of medicines during pregnancy, however. Human studies during pregnancy can be unethical and dangerous. Hence most of the human studies during pregnancy are done observationally. For example, no controls are used, but researchers might ask pregnant women to respond as to whether or not they’ve used a certain medicine. The total substances are categorized under three. They are Category A, B, C. Category A are considered the safest during pregnancy. Category B substances are fairly safe. Most of the drugs fall into category C drugs. Category C drugs are those which may have shown some indication of harm to a fetus in animal studies, and there is a lack of well-controlled human studies. When a drug is in category C, a doctor is required to assess the benefits it can deliver, compared to the risks it will bring. Then, a decision can be made as to whether a pregnant woman should continue using the medication or not. Modafinil is category C during pregnancy.

Role in birth defects?

It would be difficult to say whether modafinil will cause birth defects or not. There isn’t any clear data showing links between the use of Modafinil and birth defects. There is also not any data showing Modafinil as safe during pregnancy. There is one reported case of spontaneous abortion related with the use of modafinil and armodafinil. Also there are two known cases of intrauterine growth retardation with the use of modafinil in pregnancy. There was also a separate case of severe growth limitation and neonatal respiratory depression with the use of modafinil throughout pregnancy. No problems were seen in animal studies in lactation and breastfeeding. If a pregnant woman is already taking Modafinil, she should consult her doctor so that the doctor can go through possible risks and benefits, and decide as to whether the medication should be continued or not. It’s advised not to stop taking any medication abruptly, even during pregnancy, without first speaking to your doctor.