Provigil and Nuvigil

Provigil and Nuvigil are both prescription stimulants used to help adults with sleeping disorders be more awake and alert. Both medications are Schedule IV controlled substances, meaning they have a relatively low, but clinically significant, potential for abuse.

Both drugs have side effects that can cause serious harm to patients, including skin problems, like rashes, and psychiatric issues, such as mania, psychosis and depression.

Many patients who took these medications and experienced adverse side effects are taking legal action against the drugmakers. Some cases claim that Provigil and Nuvigil manufacturers failed to warn consumers about skin and mental health impacts. In addition, an antitrust lawsuit claimed that Provigil’s manufacturer delayed generic and more affordable options.

Doctors prescribe Provigil and Nuvigil to treat three sleep disorders: narcolepsy, obstructive sleep apnea and shift work disorder.

Provigil is the brand name for a drug called modafinil, a stimulant that the U.S. Food and Drug Administration (FDA) approved in 1998. In 2007, the FDA approved another variant of the medicine, called Nuvigil, with the active ingredient armodafinil. The medications are similar, but armodafinil typically has longer-lasting effects.

The FDA approved the medications to treat these sleep disorders:

The American Academy of Sleep Medicine warns that the medications are only approved for the treatment of these three conditions. The organization stresses that people shouldn’t use these drugs for cognitive or performance enhancements, nor should doctors prescribe them off-label for these reasons.

Despite this, some doctors do prescribe Provigil and Nuvigil off-label for conditions such as ADHD and depression.

There is a significant overlap in common Nuvigil and Provigil side effects. Clinical trials show that both drugs caused anxiety, gastrointestinal issues and headache in 5% or more of study participants.

Headache is the most common side effect of Nuvigil, occurring in 17% of clinical study subjects taking it compared to only 9% taking a placebo. There was a similar increase among Provigil study patients (34% vs. 23%).

Nuvigil and Provigil have many side effects in common. However, those who take Provigil may experience several side effects not typically associated with Nuvigil, including back pain, rhinitis and throat inflammation.

Most common side effects are minor and gradually diminish as you adjust to the new medication. If they worsen or do not go away after several days, talk to your doctor about strategies for managing them.

Managing Common Provigil and Nuvigil Side Effects

Some lifestyle changes can alleviate many of the most common Nuvigil and Provigil side effects. Staying hydrated and reducing stress may reduce headaches associated with Provigil and Nuvigil. To limit dizziness, try to move slowly when changing positions.

Gastrointestinal disorders are also fairly common with these drugs. Taking them with food may lessen nausea. Avoiding spicy and greasy foods can also help aid digestion in general. Take note of any mental health changes and report them to your doctor.

Serious Side Effects

Serious Nuvigil and Provigil side effects are rare, but instances of severe skin reactions, hypersensitivity reactions and cardiovascular events can occur. Additionally, Nuvigil packaging indicates that approximately 2% of clinical study subjects discontinued treatment due to psychiatric symptoms such as anxiety, depression or agitation. Among the placebo group, only about 0.5% of patients discontinued treatment for these reasons.

You can experience impairment of some motor skills and judgment while taking Provigil and Nuvigil, and both medications can interfere with your ability to safely operate a car or heavy machinery. You should limit these activities until you know how you react to the medicine.

Skin Reactions and Stevens-Johnson Syndrome

Although rare, serious skin reactions can occur in patients taking Nuvigil and Provigil. Postmarketing reports show rare cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis. These can be life-threatening if untreated. Even with treatment, they can be disfiguring.

SJS is a serious rash that starts with flu-like symptoms. Blisters form within several days and then burst. The condition can affect the skin and mucous membranes.

Treatment for medicine-induced SJS typically involves discontinuing the medication. However, you should not stop taking Nuvigil or Provigil without speaking to your doctor first. Many patients also need continued care in a hospital setting.

In February 2017, the FDA approved new warnings for Nuvigil about possible serious skin reactions and multi-organ hypersensitivity. The new label also included several other changes to bring product packaging up to date.

Severe Allergic Reactions and Anaphylaxis

Nuvigil and Provigil packaging include warnings about the possibility of severe allergic reactions. Both advise patients to seek medical attention if they develop symptoms consistent with a drug allergy.

Allergic reactions can become severe. They may affect your liver and blood cells. Anaphylaxis is possible in some cases.

Birth Defects and Pregnancy Complications

There appears to be an increased risk of congenital birth defects when pregnant women take Nuvigil or Provigil. The packaging of both medications discusses this risk.

Multiple patients filed lawsuits seeking compensation after taking Provigil or Nuvigil while pregnant. Additionally, the U.K. guidelines suggest that women limit or stop the use of these drugs during pregnancy.

The active ingredients in Provigil and Nuvigil can be addictive, which has resulted in the U.S. Drug Enforcement Administration (DEA) classifying them as Schedule IV controlled substances. The DEA classifies controlled substances by severity. For example, Schedule I substances, such as heroin, are the most addictive, and Schedule V substances, such as certain cough medicines, have the lowest abuse potential.

Regarding Provigil and Nuvigil, their psychoactive and euphoric effects are the primary force behind their addictive potential. The way they alter mood, perception and thinking, and their impact on the brain’s pleasure centers, can contribute to the drugs becoming habit-forming.

Because your body can become reliant on these medications, you may experience withdrawal symptoms if you abruptly stop taking them. If you experience any of the symptoms below after stopping Provigil or Nuvigil, it may be due to withdrawal.

Seizures and suicidal thoughts can also occur as a result of withdrawal, but these side effects are less common.

Some students take these medications off-label as study enhancement drugs and can become dependent on them.

Both Provigil and Nuvigil labels contain warnings about the risks of serious rashes, including Stevens-Johnson Syndrome. Manufacturers added these warnings after the FDA requested a label update in 2007.

The FDA sent a letter to Cephalon, the drug manufacturer at the time, stating, “Based on the rate of serious skin and other hypersensitivity reactions with modafinil in clinical trials and the post-marketing setting, we are requesting that you adopt a bolded statement in the Warnings section describing this risk.”

In addition to the bolded warning, the FDA also requested a statement describing two hypersensitivity reactions observed in patients during clinical trials and urged additional follow-ups and future clinical trials to better understand the risks.

Provigil and Nuvigil manufacturers have experienced regulatory scrutiny in the past concerning their medications.

Teva Pharmaceuticals, which acquired Cephalon, Inc. in 2011, settled a lawsuit with the Federal Trade Commission (FTC) for $1.2 billion in 2015. The FTC had filed an antitrust lawsuit, alleging that Cephalon had paid off generic drug manufacturers to delay the release of a generic version of Provigil.

The FTC argued that delaying the release of a generic version of Provigil was an anticompetitive move called “pay for delay.” This tactic allegedly allowed Cephalon, as the sole manufacturer of Provigil at the time, to overcharge consumers for Provigil.

More recently, patients who experienced adverse reactions from the drugs are filing Provigil and Nuvigil lawsuits. Many pending cases involve allegations that drugmakers failed to warn of dermatological or psychological risks. If you believe these drugs have harmed you, you may want to consult with an attorney to explore your legal options.

If you or someone you love uses Provigil or Nuvigil, you should be aware of potentially serious side effects. These include:

If you experience any complications, seek medical treatment as soon as possible and document the issue in case you wish to pursue future legal action.

You can also report a problem to the FDA’s MedWatch program. The FDA uses these reports to identify problems with drugs and medical devices and take appropriate action, including publishing safety alerts when necessary.