Provigil (modafinil) and Nuvigil (armodafinil) are prescription medications that are used to treat excessive sleepiness in adults. These medications have been shown to be effective in treating narcolepsy, sleep apnea and sleep disorders related to shift work. While these medications seem to be effective in treating sleep disorders, research shows they can be dangerous if taken during pregnancy. Provigil especially has been linked to serious complications and birth defects. Read on to learn more about the risk of Provigil birth defects.
How Provigil and Nuvigil Work
Provigil and Nuvigil are oral prescription medications used to treat excessive sleepiness in adults suffering from sleep apnea, narcolepsy and shift work disorder (SWD). The medications work by altering neurotransmitters in the brain, including stimulating production of histamine and dopamine. Scientists are not sure exactly how these drugs work, only that they enhance attention and wakefulness.
Provigil and Nuvigil do not cure sleep disorders, but rather treat the symptoms. These medications are not a replacement for a healthy sleep schedule.
The effect of wakefulness and attention that these medications cause has been compared to amphetamines. Many people have been prescribed Provigil and Nuvigil for “off-label” use, meaning a diagnosis other than what the drugs are approved for. Students report taking Provigil or Nuvigil to stay awake and alert while studying. The military has used the drugs for pilots and soldiers who need to stay alert while deployed.
Provigil was approved for use by the U.S. Food and Drug Administration (FDA) in 1998. Nuvigil was approved in 2007. They are manufactured by Teva Pharmaceutical Industries Ltd., which operates in several countries. There are long-standing warnings about using these medications, largely because they are controlled substances (C-IV). These drugs may be abused and patients taking them may become dependent.
Recently, more warnings have been issued about Provigil birth defects and risks. The FDA warns that taking Provigil while pregnant may cause birth defects. In the United States, Provigil is considered a pregnancy category C drug meaning that in studies the drug was found to have an adverse effect on the fetus. However, there are no controlled and adequate studies in humans to verify the exact risks.
The U.S. is not the only place where health officials are concerned about Provigil and Nuvigil. In the United Kingdom (UK) and Australia, the drugs are not recommended for use during pregnancy. In June 2019, Teva Pharmaceuticals Ireland released a separate warning about possible birth defects associated with Provigil. Later that month, Health Canada released a similar warning urging healthcare providers not to prescribe Provigil to women who are pregnant or plan to become pregnant.
Provigil Birth Defects
Women who become pregnant while taking Provigil or Nuvigil should talk to their doctor about the risks. In laboratory studies, Provigil was given to pregnant rats and rabbits in various doses throughout pregnancy. Results in both animals showed increased incidences of visceral and skeletal variations, growth restriction and reduced embryofetal development.
Provigil is linked in animal studies to complications and birth defects including:
- Growth restriction
- Spontaneous abortion
- Congenital malformations
- Heart defects
- Congenital anomalies
- Fetal toxicity
Teva Pharmaceuticals warns that taking Provigil increases the risk of congenital malformations by as much as 15 percent. This is much higher than the general rate of three percent in the general population. Though there are no adequate studies in humans, there are known cases of intrauterine growth restriction and spontaneous abortion linked to Provigil and Nuvigil.
More Information Needed about Provigil Birth Defects
The FDA currently does not know the extent of the risk of Provigil birth defects. Also, it is not known whether Provigil or Nuvigil can be passed through breast milk. More research is needed before definite conclusions can be made. What is known, however, is that women who are pregnant should talk to their doctor before taking either of these medications
There is a registry set up for women who become pregnant while taking Provigil. This registry collects information about the safety of Provigil during pregnancy. Women who take Provigil are encouraged to sign up for the registry and record their experience. This information can help assess safety and effectiveness and identify risks.
To find out more about other medications that are known to cause birth defects, take a look at our medication birth defects page.