Modafinil/Armodafinil - Birth Control and Pregnancy
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Did you know that Modafinil & Armodafinil can reduce the effectiveness of hormonal contraceptives?
Modafinil (sometimes referred to by it's brand names Modavigil or Provigil ) and its derivative Armodafinil (also known as Nuvigil) are medications that promote wakefulness. They are prescribed to assist with excessive sleepiness associated with sleep disorders such as Narcolepsy, Idiopathic Hypersomnia and Sleep Apnea. They are also sometimes prescribed to combat fatigue in people who work shift work and also in other conditions such as multiple sclerosis. It is not known how modafinil/armodafinil promotes wakefulness. It appears to influence brain chemistry that increases wakefulness however the precise mechanism(s) is unknown. There are numerous side effects to these medications. Some more serious than others and some more likely than others. You can read about them in the TGA's product information: Modafinil or Armodafinil and also the consumer information leaflet Modafinil or Armodafinil. In this post we look specifically at modafinil/armodafinil and birth control and pregnancy. We hear from a number of women who are unaware of the potential failure of combined hormonal contraception, such as birth control pills, patches and implants when taken together with modafinil or armodafinil. Even more alarming are the number of doctors who also seem to be unaware of this information. Here are the facts: Contraception
A specific enzyme in the liver breaks down modafinil/armodafinil, which is then eliminated in the urine. The same enzyme that is responsible for clearing the body of modafinil/armodafinil also breaks down contraceptives. Studies have shown that, when taken together (contraceptives and either modafinil or armodafinil), the overall blood levels of contraceptives decrease by 18 percent, resulting in potentially significantly lower effectiveness of contraceptives . It is recommended that you should use an additional method of contraception while you are taking modafinil/armodafinil and for one month after discontinuing these medications. Pregnancy
Embryotoxic effects have been observed in some, but not all animal studies. There have never been adequate clinical trials in pregnant women to establish safety . This is from The Society for Women’s Health Research; "Like a lot of medications, modafinil (and armodafinil) is pregnancy category C, meaning animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled pregnancy outcome studies in humans. The potential benefits, though, may warrant use of the drug in pregnant women despite the potential harms . Therefore, it is important for both health care providers and women taking modafinil (or armodafinil) to avoid unplanned pregnancies while on the drug and to make an informed choice of continuing treatment only if the benefits outweigh the risks." While there have been no adequate clinical trials in humans, since writing this post TEVA Pharmaceuticals has recently reported on the results of the 2018 annual report of the ongoing Nuvigil/Provigil (modafinil) Pregnancy Registry in the United States. Please refer to the update below* Update 25/12/2018: A case study on the lack of significant transfer of modafinil from mum to baby via breastmilk was published in the Journal of Clinical Sleep Medicine in Dec 2018. “The relative infant dose was calculated to be 5.3%, below the threshold of concern for drug passage via breast milk.” Click here to read more. *Update 24/7/2019 URGENT ALERT REGARDING MODAFINIL AND