Date approved: December 24, 1998
Status: Prescription only
Approved uses: Provigil is used to improve wakefulness in people who have excessive daytime sleepiness associated with narcolepsy, have stopped breathing while sleeping or have difficulty breathing while sleeping (obstructive sleep apnea/hypopnea syndrome), or have shift work sleep disorder.
Off-Label uses: Suppresses need for sleep, cognitive enhancing “smart drug”, allays symptoms of neurological fatigue associated with Multiple Sclerosis, also used as a treatment of ADD/ADHD
Common side effects include headache and nausea. More uncommon side effects can include nervousness, insomnia, anxiety
anorexia and dry mouth. Occasional severe dermatologic reactions requiring hospitalization can also occur.
Provigil, generic name of Modafinil, is a is a next generation stimulant, generally prescribed to treat narcolepsy, manufactured by the pharmaceutical company Cephalon Inc. It is not a typical stimulant, in that it is of a new class of drugs called eugeroics. These stimulants tend to increase alertness and may not have the peripheral (body) effects or addiction/tolerance/abuse potential of the traditional stimulants. They are alleged to have a minimal effect on sleep structure and do not cause rebound hypersomnolence or “come down” effects.
Provigil itself is often described as a “wakefulness promoting agent.” The drug is sometimes prescribed off-label for ADD/ADHD. In mass-media advertisements and websites, Cephalon markets the drug for improving “alertness” and reducing “excessive daytime sleepiness.” According to the Food and Drug Administration, provigil should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of either narcolepsy, Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS), and/or Shift-Work Sleep Disorder (SWSD) has been made. Unfortuately, there is a growing trend of cases where individuals, especially teenage students or those attempting to recover from some narcotic addictions, are taking Provigil for non-approved uses. These can include as a study aid, to counter some symptoms of drug addiction, or to aid with some symptoms of depression.
Recently, a class action suit was filed, claiming that Cephalon and other drug companies illegally conspired to keep generic versions of Provigil off the market, depriving class members the opportunity to purchase a lower priced generic. The case is pending in U.S. District Court for the District of Pennsylvania. Eligible class members for the Provigil lawsuit include all persons and third-party payors who paid some or all of the purchase price for Provigil from December 23, 2003 to present.
Provigil Side Effects: The Potential Danger
Provigil (Modafinil) is a prescription medication usually given to people who suffer from narcolepsy, sleep apnea, or other sleep disorders that cause the sufferer to be unable to stay awake. Provigil is generally marketed as a �wakefulness promoting agent� as its purpose is to keep the user awake, among other things. Provigil is generically known as Modafinil, which is manufactured by the pharmaceutical company Cephalon.
Who Can Take Provigil?
Provigil could potentially be prescribed to any adult with sleep disorders that make them unable to stay awake. However, at no point should this medication be given to children. It is prescribed in the category of central nervous system (CNS) stimulant. Some people are hypersensitive to medications that fall in this category and if you have had previous problems with a CNS stimulant such as Ritalin, it is essential that you notify your health care professional before being prescribed Provigil. Also, this medicine should be avoided for people who suffer from or have a history of depression as side effects of Provigil could make the depression return.
What are Some Side Effects of Provigil?
There are many side effects of Provigil, ranging from mild to severe. The majority of patients who take Provigil or Modafinil have only mild to moderate negative side effects.
Some of these side effects are:
• A fever, sore throat, and nausea
• You may find that you bruise more easily or bleed more freely
• Abnormal heartbeats or chest pain
• Depression or depressive thoughts
• Peeling, blistering, and red skin rash
Provigil also has the possibility of causing a potentially fatal skin disease known as Stevens-Johnson Syndrome. This disease is also known as Toxic Epidermal Necrolysis and it usually comes from adverse reactions to medication. People who suffer from this disease could be in extreme pain and experience anxiety. Stevens-Johnson can have an affect on a person of any age, but it seems to appear more in older men and women, but this is possibly because this is the generation that tends to take medication linked with the disease.
What are Symptoms of Stevens-Johnson Syndrome?
If you are currently taking Provigil or Modafinil and are experiencing any of these symptoms, contact your doctor immediately in the event that they are symptoms of Stevens-Johnson:
• Feverishness, coughing, headaches
• A red rash across the face and upper body, which can form into painful blisters
• The skin can become fragile and peel off of the body easily, often in large sheets
• In some cases, the hair and nails also fall away
The rash and blisters can also leave the skin looking as though its been burned, and these can easily become infected, which is the highest cause of death. If any of these symptoms are experienced, it is essential to see a health care professional, as early treatment gives the best chance of curing the disease.
Action Taken to Promote Awareness of Provigil Side Effects
According to MedWatch posted by the FDA, the pharmaceutical company Cephalon updated the labels on Provigil to include warnings about the possible contraction of diseases such as Stevens-Johnson and patients who are experiencing symptoms of this disease should discontinue use of Provigil immediately.
If you or anyone you know has encountered any negative side-effects as a result of using Provigil, consider consulting with a Provigial law firm today to learn what, if any, compensation you may be entitled to.