Provigil is a prescription medicine that was brought to market by the pharmaceutical company, Cephalon. The medicinal component of Provigil is modafinil, which was approved by the U.S. Food and Drug Administration, or FDA, in 1998 to promote wakefulness and combat the profound sleepiness caused by conditions such as narcolepsy and sleep apnea, according to Drugs.com. Rxlist.com adds that modafinil is assumed to work by exciting natural brain substances, referred to generally, as neurotransmitters. Provigil is manufactured as 100 and 200mg tablets.
Serious Dermatological Problems with Provigil
In 2007, the U.S. Federal Drug Administration declared a safety alert in regards to modafinil use and its connection with potentially fatal skin conditions, such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug rash with eosinophilia and systemic symptoms. What prompted the safety alert was post-marketing reports of adults and children experiencing severe allergic reactions of the skin, which included inflammation, necrosis and infection. With Stevens-Johnson syndrome, skin-cell death causes the epidermis to separate from the dermis and mucous membranes, which can result in severe pain, infection and death.
Psychiatric Problems Associated with Provigil
Druglib.com cites that the exact way in which modafinil causes wakefulness in the brain is unknown, although it does have wake-promoting mechanisms similar to amphetamines, which excite the central nervous system. Modafinil's main affect appears to be the neurotransmitters of the brain, which also causes unwanted side effects. Drugs.com warns that modafinil produces euphoric effects, and alterations in mood, perception and thinking which are also noted with other central nervous system stimulants.
Reports of psychiatric problems being caused by Provigil are much more common in post-marketing reports, when compared to the symptoms reported from the controlled clinical trials, according to Rxlist. At best, psychiatric problems caused by Provigil use occur "rarely;" at worst, they are an "uncommon" occurrence. Post-marketing reports have noted the following serious psychiatric-type symptoms associated with Provigil: mania with episodes of depression, delusions, hallucinations and suicidal tendencies. These symptoms appeared more frequently in people who had a history of psychiatric problems, so modafinil products should not be prescribed to patients with a history of psychosis, mania, depression or suicidal thoughts or behaviors.
More Common Problems with Provigil
More common problems, albeit less serious, have been noted with Provigil use. According to the "Compendium of Pharmaceuticals and Specialties," the most common symptoms reported from multiple controlled clinical trials of Provigil included headaches, in up to 34 percent of patients depending on dosage, nausea, in up to 11 percent of patients, post-nasal drip, as high as 7 percent of the time, back pain, as high as 6 percent, diarrhea, also in about 6 percent of patients and dizziness, in up to 5 percent of patients. From post-marketing reporting, other problems were noted, mainly, agitation, insomnia, anxiety, irritability, aggressiveness, confusion and nervousness.
References
- Drugs.com: Modafinil - Provigil
- Rxlist.com: Provigil - Modafinil
- FDA Safety Alert (2007): Provigil - Modafinil
- Druglib.com: Provigil - Modafinil
- "Compendium of Pharmaceuticals and Specialties"; Canadian Pharmacists Association; 2010
