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Cephalon Response to JAMA Article, “The Effects of Modafinil on Dopamine and Dopamine Transporters In The Male Human Brain”

The findings outlined in the JAMA article “The Effects of Modafinil on Dopamine and Dopamine Transporters in the Male Human Brain” are consistent with FDA approved labeling for PROVIGIL (modafinil) Tablets [C-IV].

The Drug Enforcement Administration determined that modafinil be classified as a Schedule IV drug because, relative to other drugs or substances listed on Schedule III, it has a low potential for abuse and because abuse of modafinil may lead to limited physical or psychological dependence.  For information about drug scheduling please click here.

PROVIGIL has been marketed for 10 years.  During this period, extensive post-marketing information from millions of patients treated with modafinil has been reviewed.  Similarly, current product labeling reflects the results of ongoing FDA review of PROVIGIL over the course of its marketing history.  It is important to note that the PROVIGIL Full Prescribing Information includes a statement that physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse and to observe patients for signs of misuse or abuse or drug-seeking behavior.   

The FDA-approved Full Prescribing Information also includes Patient Information, with the statement "PROVIGIL is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep PROVIGIL in a safe place to prevent misuse and abuse. Selling or giving away PROVIGIL may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs."     

ABOUT PROVIGIL

PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy.

PROVIGIL is not indicated for use by healthy individuals and physicians should use appropriate caution in prescribing this medication.  Patients with questions about the appropriate use of PROVIGIL should contact their healthcare provider.  

IMPORTANT SAFETY INFORMATION

Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil.

Modafinil is not approved for use in pediatric patients for any indication.   

Any drug affecting the central nervous system (CNS) may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until reasonably certain that PROVIGIL therapy will not adversely affect their ability to engage in such activities.

Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. In controlled trials in adults, psychiatric symptoms resulting in treatment discontinuation were anxiety, nervousness, insomnia, confusion, agitation, and depression. Caution should be exercised when PROVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing PROVIGIL if psychiatric symptoms develop.

In the placebo-controlled clinical studies in primary disorders of sleep and wakefulness, the most commonly observed adverse events (?5%) associated with the use of PROVIGIL compared with placebo-treated patients were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse event profile was similar across these studies.

For more information, please see the FDA -approved full prescribing information for PROVIGIL.