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Armodafinil In Pregnancy- Warnings and Precautions

Last updated on 26 Jan, 2024

Armodafinil is a medication that is not recommended during pregnancy and breastfeeding, as it is considered a category C drug by the FDA. Studies indicate that it can cross the blood barrier to reach the infant and affect their growth and development. Whereas in nursing mothers, Armodafinil can pass into the breast milk of the mother, thus increasing the risk of side effects for the baby. 

Pregnancy is a delicate phase in a woman’s life. During this phase, she must be careful and take the necessary precautionary measures. 

If you are taking Armodafinil ( a medication to treat excessive daytime sleepiness), you should always consult with your doctor before continuing the medication during pregnancy. 

The blog represents all the adverse effects of Armodafinil during pregnancy and breastfeeding to ensure the safety of your baby.  

Armodafinil And Pregnancy: An Overview 

Armodafinil is an isomer of Modafinil and is the prescription medication for treating excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. 

Armodafinil is a Schedule IV prescription medication whose clinical use was approved by the FDA in the US in 2007. It is available under different brands, such as Waklert, Artvigil, and Nuvigil which represent similar effectiveness and potency as generic Armodafinil

Cephalon Inc. (a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.) is the manufacturer of Armodafinil. 

Pregnancy-

It is the stage where a woman carries a baby in her womb for 9 months. The stage is divided into three trimesters. 

  • The first trimester (conception to 12 weeks) includes conception, where the sperm fertilizes the egg. During the first trimester, the chances of miscarriage are at the highest. 

  • During the second trimester(13 weeks -27 weeks), the movement of the fetus is felt.  In this stage, you may gain some weight as the baby slowly grows. 

  • The third trimester (28-40) weeks is when your baby is fully developed, and your body prepares for the birth. 

However, the length of the pregnancy varies from woman to woman. The babies are considered full-term, if they are born between 37-42 weeks [1].

Is It Safe To Take Armodafinil While Being Pregnant?

The FDA classified Armodafinil as a category C drug (animal studies have shown risk to the fetus, but no controlled studies are available). It is thus recommended for people to avoid the intake of Armodafinil tablets during pregnancy without consulting a doctor. 

Armodafinil Consumption And Birth Defects 

There are many studies that show that Armodafinil is associated with intrauterine growth restriction, as well as spontaneous abortion. Other studies show developmental toxicity (increased embryofetal and offspring mortality and decreased fetal growth) at certain exposure levels. 

A recent study (2021) by Sigal Kaplan et al. evaluating the outcome of exposing a fetus to Modafinil and Armodafinil during pregnancy suggests that there is an increase in congenital malformations (MCMs) in the fetus. 

The interim data from the pregnancy registry shows the rate of major congenital malformations with Armodafinil is found to be 17.3% [3].

Contraceptives During Pregnancy

contraceptives-during-pregnancy

 

 It is always suggested to avoid contraceptives during pregnancy. 

The reason behind this is that-

The liver enzymes are responsible for the breakdown of Armodafinil and any other medication, such as contraceptives. When administered together, these enzymes fail to metabolize them properly, thus lowering their effectiveness. 

Armodafinil  Breastfeeding Warnings

One of the precautionary measures is to avoid Armodafinil at the stage of breastfeeding, as it might harm your baby. Even though the amount of drug excreted into breast milk is estimated to be very low (5.5% of the maternal dosage), it is still advisable to take Armodafinil tablets by nursing women under medical supervision. 

A study by Catherine Leggett et al. shows that a relatively small amount of Armodafinil passes into human milk, resulting in limited infant exposure, as shown in the graph below[4]. 

graph-armodafinil

Alternatives Of Armodafinil During Pregnancy

The risks of using a medication like Armodafinil are high during the first trimester of the pregnancy. During this stage, the majority of the baby’s development is under process, and the vital organs are formed. 

There are certain other medications that are considered a safer option to treat excessive daytime sleepiness during pregnancy. 

Four of them are listed below-

  • Omega 3-fatty acids

  • Co-enzyme-10

  • L-tyrosine

  • B-vitamins. 

Along with the above medications, you can also try certain lifestyle changes for better results. For instance- A change in your sleep routine, along with meditation, helps you a lot during pregnancy. 

Our Final Thoughts On Taking Armodafinil During Pregnancy And Breastfeeding  

We can conclude that it is not safe to take Armodafinil during pregnancy or lactation. If someone wishes to take the medication during this stage, it is advisable to consult with your doctor. Some of the key points from this blog are-

  • It is a category C medication. 

  • Do not use contraceptives while taking Armodafinil.


FAQ's

The FDA classifies Armodafinil as a category C drug, which denotes Armodafinil to be an unsafe drug during pregnancy.

Hormonal birth control pills, implants, patches, and IUDs may not work if you are taking Armodafinil during pregnancy.

The Armodafinil efficacy was found to be comparable with 200 mg of Modafinil. Armodafinil was found to be 1.33% more potent than modafinil, but the safety profile of both substances was found to be similar.

Yes, Armodafinil is considered safe and is recommended to be taken once a day for 2 weeks.

The effects of Armodafinil lasts for about 12-15 hours. However, Armodafinil takes 60-75 hours to be completely removed from the system.


References-

  1. Pregnancy, Wikipedia.

  2. Taking Armodafinil While Pregnant, The Recovery Village.

  3. Armodafinil use during pregnancy, drugs.com.

  4. Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil, SageJournals.

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Disclaimer: We do not provide any medical advice.

The contents of Healthma are for informational purpose only and is taken by a thorough evaluation of research papers and Journals. We do not provide professional medical advice, treatment, or diagnosis. We advise all readers to consult a physician before consuming any medication mentioned on the website.