Administration Of Modafinil And Armodafinil During Pregnancy

September 17, 2021

Modafinil and Armodafinil are two nootropic drugs prescribed to treat excessive daytime sleepiness or drowsiness disorder. The disorder may be a result of any of the following conditions:

  • Narcolepsy (uncontrollable drowsiness during daytime)
  • Obstructive sleep apnea (breathing is obstructed or stopped for short periods while sleeping)
  • Shift work sleep disorder (affects people who work in the usual sleeping hours)

Both Modafinil and Armodafinil are FDA-approved Schedule IV prescription drugs. Armodafinil is the R-(-)-Enantiomer of Modafinil which is a racemic compound. Both drugs have been found to be helpful in tackling the daytime sleepiness problem arising from all three conditions. Armodafinil is also known to reduce fatigue. To treat narcolepsy and obstructive sleep apnea, doctors recommend taking one Waklert 150 mg tablet (Armodafinil) every day at the same time in the morning. For shift work sleep disorder, the tablet is to be taken an hour before your work time. However, the dosage may vary according to your diagnosis.  

Modafinil And Armodafinil As Cognitive Enhancers

Although, both the drugs were originally meant to treat the problem of excessive daytime sleepiness, they have also been used off-label as “smart drugs”. Modalert 200 mg (Modafinil) is a popular choice among students and others in high-performance careers. It is known to enhance alertness, working memory, and helps maintain focus for sustained periods. This has led to reckless use of these drugs which has got the doctors and scientists worried about the potential side effects of these medicines. Common side effects of these medicines are dizziness, nausea, insomnia, addiction, and headache. But continued research has raised crucial questions on the safety of pregnant women (and their babies) using them. 

Are Modafinil And Armodafinil Safe To Administer During Pregnancy?

Several research studies conducted by different organizations have shown the possibility of congenital malformation in the babies of women consuming these drugs during pregnancy. A Danish study, published in JAMA Psychiatry in 2020 compared the pregnancy outcomes of women who were exposed to Modafinil in their first trimester with those who were not. It concluded that as many as 12% of modafinil-exposed pregnant women showed major congenital malformation, as opposed to only 3.9% of unexposed pregnant women. Although, this was a relatively smaller study and included only 49 women who were taking Modafinil during pregnancy, it still illustrates the fatal implications that the drug may have on fetuses. The newborns whose mothers were exposed to Modafinil were found to be at a high risk of contracting congenital torticollis, hypospadias, cardiac malformation, and other serious health issues. Armodafinil being an identical drug is suspected to have similar side effects. 

According to the FDA-approved labels for the drugs, Modafinil and Armodafinil are put under the pregnancy category C. It has cited fetal malformations in animal subjects and mentions the under-studied status of well-controlled human tests. There are some reports of spontaneous abortions and restricted intrauterine growth of the fetus in pregnant women using Modafinil. The document categorically states that the drug should be administered to pregnant women only if the potential benefit is greater than and justifies the potential risk posed to the fetus. 

There is a pregnancy registry in place to keep track of the treatment outcomes of pregnant women using either of these drugs. The health service provider can register their patients or the patient can register herself on this number 1-866-404-4106. The data gathered using this registry is reported to the FDA on an annual basis. The data pooled between Feb 2010-Feb 2019 showed that 13% of the live births had contracted major malformations. This study has its limitations because it is a voluntary registration but still, it is better to not take unnecessary risk by using Modafinil or Armodafinil during pregnancy. 

Safety Guidelines  

In 2019, Health Canada had issued safety guidelines relating to the use of modafinil and its risks. It mentions that Modafinil has been known to induce major fetal congenital malformations. It also advises all the health professionals to discuss the potential risks of this drug with the women in advance. According to it, it is mandatory to get a negative pregnancy test report before starting the use of Modafinil. Additionally, it mentions the possibility of steroidal contraceptives becoming less effective while using Modafinil, so extra contraceptive measures should be put in place. Women who wish to conceive in the future must consult their doctors at least 2 months in advance about stopping the use of Modafinil.  

Conclusion

Modafinil and Armodafinil are prescription drugs mainly used to treat the problem of excessive daytime drowsiness. However, recently they have been also used to improve focus and alertness by people engaged in jobs that need better concentration and memory. In the light of such increased usage of these drugs, ongoing studies have been trying to ascertain their safety level for pregnant women. Most of the recent studies have shown a potential risk of fetal congenital malformation, including congenital heart diseases in the fetuses exposed to these medicines. Therefore, it is advisable to consult a physician before starting treatment with either of these drugs, especially if you wish to get pregnant in the near future. 

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Andi Perullo de Ledesma

I am Andi Perullo de Ledesma, a Chinese Medicine Doctor and Travel Photojournalist in Charlotte, NC. I am also wife to Lucas and mother to Joaquín. Follow us as we explore life and the world one beautiful adventure at a time.

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