Provigil narcolepsy medication - Benefits and side effects, safety, risk, danger
July 1 2017 by
Ray Sahelian, M.D.

Provigil is a prescription medication to treat narcolepsy. This drug is made by the pharmaceutical company Cephalon Inc.

Provigil is a psychostimulant. It improves wakefulness and vigilance, but its pharmacological profile is different from the amphetamines, methylphenidate (Ritalin) or cocaine. Provigil is less likely to cause jitteriness or anxiety than traditional stimulants. Subjectively, it feels smoother and cleaner than the amphetamines. Modafinil, the drug's generic name, is sometimes used as a study aid by college students.
   Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. Available by prescription since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion in 2010. The company has developed a spin-off called Nuvigil.

Habit forming
A small government study completed in 2009 and led by Dr. Nora Volkow, director of the National Institute on Drug Abuse, found that brain scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction.

Provigil and sleep deprivation
The non-amphetamine, wake-promoting drug, Provigil counters the adverse effects of sleep deprivation on working memory. In a randomized, double-blind study, Dr. Robert Joseph Thomas, of Beth Israel Deaconess Medical Center, Boston, and Dr. Kenneth K. Kwong of Massachusetts General Hospital, Charlestown examined the effect of Provigil on working memory and brain activation in the executive network following overnight sleep deprivation. Functional magnetic resonance imaging was used to assess the functional neurobiology of executive function in eight sleep-deprived medication-free men (ages 21 to 35 years) treated with 200 mg of Provigil or placebo. They underwent a verbal working-memory task with 3 levels of difficulty. Subjects in the sleep-deprived condition, had approximately 28 hours of continuous wakefulness, and in the rested condition, had 8 hours of scheduled sleep opportunity. The team assessed brain activation patterns and regional signal intensity based on the blood-oxygen level-dependent signal. Provigil countered the ill effects of sleep deprivation on working memory, but only when the task difficulty was moderate.
   Dr. Sahelian says: There are a number of natural supplements that could be helpful in sleep deprivation and as a good natural alternative to Provigil. These include Mind Power Rx mind booster, Eyesight Rx, acetylcarnitine, DMAE, and other nutritional supplements.

Provigil and depression - mood elevation
A Randomized, Double-Blind, Crossover Trial of Provigil on Mood.
J Clinical Psychopharmacology. 2007. Departments of *Pharmacology, daggerPsychiatry, double daggerMedicine and section signNeurology, Autonomic Dysfunction Center, Division of Clinical Pharmacology, Vanderbilt University, Nashville, TN.
Provigil, a medication for the excessive sleepiness associated with narcolepsy, has been hypothesized to improve not just alertness but mood as well. The purpose of this study was to determine how treatment with Provigil affects mood in healthy volunteers. Normal healthy volunteers (n = 12, 10 men and 2 women; 30-44 years) underwent a 3-day, counterbalanced, randomized, crossover, inpatient trial of Provigil (400 mg daily) versus placebo with 4-day washout period between 2 treatments. Mood was assessed daily using both the Positive and Negative Affect Schedule and a general mood scale, which consisted of 10 bipolar adjective ratings based on a severity scale ranging from 1 to 10. Provigil increased general mood and Negative Affect scales relative to placebo and had a significant effect on Positive Affect scales. These results suggest that Provigil may have general mood-elevating effects accompanied by increased negative affect (anxiety).
   Dr Sahelian says: it is possible that a medication (such as an amphetamine) may help depression or improve mood in the short term, but then later cause a crash with severe depression or other side effects.

Provigil side effects, safety, danger, risk
The most common Provigil side effects are headache, nausea, nervousness, and rhinitis. Additional Provigil side effects include diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. Additional Provigil side effects may be discovered as more people use this drug for prolonged periods. Could heart problems occur?

Indian J Pharmacol. 2015. Fixed drug eruptions with modafinil. Provigil is a psychostimulant drug, which has been approved by the US Food and Drug Administration for the treatment of narcolepsy associated excessive daytime sleepiness, sleep disorder related to shift work, and obstructive sleep apnea syndrome. However, presently it is being used as a lifestyle medicine; in India, it has been misused as an "over the counter" drug. Provigil is known to have several skin side effects. Fixed drug eruption is a distinctive drug induced reaction pattern characterized by recurrence of eruption at the same site of the skin or mucous membrane with repeated systemic administration.

J Clin Pharmacol. 2013. Tako-tsubo cardiomyopathy following modafinil use.

European health regulators recommend restricting the use of Cephalon's sleep disorder drug Provigil for treating narcolepsy only, over concerns that risks may outweigh the benefits of the medicine in other uses. The European Medicines Agency said doctors and patients should no longer use medicines that contain modafinil - the active ingredient in Provigil - for sleep apnea, chronic shift work sleep disorder or other previously approved uses. The benefits of the drug only outweighs the risks in the treatment of narcolepsy. There are cardiovascular risks with modafinil and it should not be prescribed to patients with uncontrolled high blood pressure or irregular heart rhythms. July 2010.

Questions
Q. I am taking Provigil. I have narcolepsy and am searching everyday for something that keeps me awake. My mind is awake all the time with modafinil, but does tyrosine make you have more energy as a whole or just wired.
   A. Tyrosine usually makes one more wired. Many people tell us Eyesight Rx and or Mind Power Rx help the mind stay alert and focused and provide good energy. Perhaps they can be a substitute for Provigil in some people.