Provigil and Nuvigil are prescription medications that promote wakefulness in people suffering from certain sleep disorders. However, recent findings suggest these drugs are associated with an increased risk for birth defects when taken during pregnancy.
Provigil (modafinil) and Nuvigil (armodafinil) are indicated to reduce excessive sleepiness associated with sleep apnea, narcolepsy, and shift work sleep disorder. However, neither drug cures sleep disorders, nor should they take the place of adequate rest.
Nuvigil and Provigil are Schedule 4 Controlled Substances, which indicates abuse of either medication could lead to limited physical dependence or psychological dependence.
The U.S. Food & Drug Administration (FDA) cleared Provigil for narcolepsy in 1998. Five years later, the drug’s approved indications were expanded to include sleep apnea and shift work sleep disorder. The agency went on to approve Nuvigil for all three indications in 2007.
Cephalon initially marketed Provigil and Nuvigil in the United States. However, the franchises became part of Teva Pharmaceutical’s portfolio when it acquired Cephalon in October 2011.
Provigil and Nuvigil are not stimulants, but they do have a stimulant-like effect on the central nervous system. Nuvigil is the R-enantiomer of racemic modafinil, which means it has a slightly different chemical structure than Provigil.
While it’s not actually clear how these medications work, it’s thought they increase the body’s sensitivity to dopamine, a neurotransmitter associated with wakefulness. While Nuvigil appears to be just as effective as Provigil, they’ve never been compared in a head-to-head clinical trial.
Patients with sleep apnea or narcolepsy take a single 200 mg dose of Provigil each morning. The same dose is taken one hour before the start of a shift by people experiencing shift work sleep disorder.
For narcolepsy and sleep apnea, Nuvigil is taken once each morning in dosages ranging from 150 mg to 250 mg. Patients with shift work sleep disorder take a single 150 mg dose an hour before the start of their shift.
It’s recommended that doctors reduce the dosage for both drugs when treating individuals with impaired liver functions. They should also consider a smaller dose for geriatric patients, and closely monitor those individuals.
The most common side effects associated with Provigil and Nuvigil include headache, nausea, dizziness, trouble sleeping, and anxiety. Provigil may also cause back pain and stuffy nose.
Both drugs can also cause more serious side effects, including:
Nuvigil and Provigil should be used cautiously in people with a history of arrhythmias or heart disease.
Because both drugs might reduce the effectiveness of hormonal contraceptives (birth control pills, NuvaRing, contraceptive patch, Nexplanon implant, Depo Provera injections, and hormonal IUDs), women taking Provigil or Nuvigil should use an additional barrier method or an alternative non-hormonal method of birth control during treatment, and for one month after treatment ends.
The FDA has placed Provigil and Nuvigil in Pregnancy Category C:
“Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”
In June 2009, the agency established a Nuvigil/Provigil Pregnancy Registry to study their effect on fetal development and pregnancy. The registry tracks pregnant women exposed to at least one dose of armodafinil or modafinil at least 6 weeks prior to conception and/or during pregnancy. A report detailing the registry’s findings is issued annually.
According to a Health Canada Safety Alert issued on June 20, 2019, results from the Nuvigil/Provigil Pregnancy Registry’s 2018 annual report suggested a higher rate of major birth defects and other adverse reactions among children exposed to the drugs in utero. Teva Innovation Canada apparently notified the regulator of the findings several months earlier.
The alert warned clinicians not to prescribe modafinil (armodafinil is not approved for sale in Canada) to pregnant women, or those who plan on becoming pregnant. Healthcare providers were also directed to ensure women of child-bearing age have a negative pregnancy test at least one week before initiating treatment with modafinil. These patients should also be told that they MUST use an effective method of non-hormonal contraception during treatment, and for two months after discontinuation of treatment.
Healthcare providers in Ireland and France apparently received similar notifications. But as of July 17, 2019, a Nuvigil/Provigil birth defects warning had not been issued to clinicians in the United States.
Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.