Many people take modafinil, which is used to treat narcolepsy. Previous studies have linked the drug with an increased risk of birth defects in babies born to mothers who took it during pregnancy.

But a new study finds no link. Researchers used national prescription drug registries to identify pregnancies exposed to modafinil and compared them to a control group of pregnancies exposed to the attention-deficit/hyperactivity disorder medication methylphenidate.

What is modafinil?

Modafinil Australia is a wakefulness-enhancing drug used to treat excessive daytime sleepiness associated with conditions such as narcolepsy, obstructive sleep apnea/hypopnoea syndrome (OSAHS), and shift work sleep disorder (SWSD).

It can also enhance cognitive abilities. It has a reputation for being able to boost memory and concentration and improve attention. It is often prescribed to people in competitive environments such as athletes, students, or employees who work late hours.

Health Canada issued a safety alert in 2019opens in the new window that modafinil is contraindicated in pregnant women or women who may become pregnant due to preliminary data from the U.S. Provigil/Nuvigil Pregnancy Registry. The registry recruits individuals who took modafinil or armodafinil at least 6 weeks before conception and during pregnancy to determine the incidence of congenital malformations.

The initial data from the registry indicate that major congenital anomalies occur in about 15% of infants exposed to modafinil and armodafinil during pregnancy. This is higher than the 3% rate in the general population. The findings are based on a limited number of cases, and other factors may increase the risk for these outcomes.

The FDA has rated modafinil and armodafinil in pregnancy category C, meaning that they can cause harm to the fetus. There have been reports of intrauterine growth retardation and spontaneous abortion in association with modafinil and armodafinil.

They are also known to interact with several medications including sedatives, antidepressants, and antibiotics. They can reduce the effectiveness of oral contraceptives and alternative or additional methods of birth control are recommended during treatment and for 2 months after stopping the drug.

Does modafinil cause birth defects?

Despite reports of babies born with birth defects like congenital heart conditions, hypospadias, and orofacial clefts after mothers took modafinil (Waklert 150 mg) to treat their narcolepsy during the first trimester of pregnancy, new research suggests that there is no link.

A study published this year in the Journal of the American Medical Association analyzed data from two million pregnancies in Sweden and Norway. They looked at 133 infants born to women who were exposed to modafinil during their first trimester. The results showed that these children had the same rates of major malformations as infants of mothers who did not take modafinil.

Currently, the Medicines and Healthcare Products Regulatory Agency (MHRA) in Ireland has released a drug safety alert about modafinil and its possible links to fetal defects. The MHRA recommends that women of childbearing potential use effective methods of contraception when taking modafinil and for 2 months after stopping it. It also warns that modafinil could reduce the effectiveness of hormonal birth control pills.

However, some obstetricians have urged patients to continue to take modafinil while pregnant. This is because the MHRA classified the medication as Class C, which means that there is limited or insufficient evidence of harm to the fetus. This is much lower than the “Class A” medications that should not be used during pregnancy.

Does modafinil make you smarter?

Modafinil has been shown to boost cognitive performance in some people, but the results of other studies are mixed. It seems to work by stopping nerve cells from reabsorbing the excitatory chemical dopamine, which can make you feel jittery or anxious. It is also thought to improve attention, learning, and executive function.

It is a popular drug among people who must work long hours and concentrate for extended periods, like doctors, students, and military personnel. In one small study, doctors who took modafinil after a sleepless night performed better on cognitive tests than those who did not.

Unlike traditional stimulants, such as amphetamines and methylphenidate, modafinil is not associated with feelings of addiction or highs and lows. However, it is important to talk to your doctor about taking this drug if you are pregnant or planning to become pregnant.

Modafinil has been linked to a higher risk of birth defects in some women who are pregnant or trying to get pregnant. It can also interfere with hormonal birth control, so it is important to use alternative methods of contraception.

In addition, modafinil is known to increase liver enzyme activity, which may affect other medications that require a similar interaction with your body. Be sure to tell your doctor if you are taking any other medications, especially those that might interact with hormones.

What are the risks of taking modafinil during pregnancy?

Modafinil is considered a "Class C" medication by the FDA, meaning that no clear data are showing that it causes harm to a fetus. However, it is important to discuss any risks and benefits of taking the medication during pregnancy with your obstetrician.

A recent study of women who took modafinil during the first trimester of their pregnancy found that there was no increased risk of birth defects compared to women who did not take the drug.

The researchers used data from nationwide medical birth registries in Sweden and Norway to identify all pregnancies involving a singleton baby and a mother who reported using modafinil during the first trimester.

Of 133 infants born to mothers who used modafinil in the first trimester, 2.6% had a major malformation. This was similar to the 2.1% rate for infants born to mothers who did not use the drug in utero. The authors noted that the results were inconclusive and that other factors could be influencing the outcomes.

Nonetheless, the marketing authorization holder of modafinil (under the brand name Nuvigil) has issued a direct healthcare professional communication alerting that there is evidence that the drug increases the risk of congenital malformations in the fetus.

As a result, Health Canada recommends that women who are pregnant or planning to become pregnant should not take the drug. The agency also advises healthcare professionals to ensure that all female patients of reproductive potential use effective contraception during treatment and for two months after the end of treatment.