Cephalon Response To JAMA Article "The Effects Of Modafinil On Dopamine And Dopamine Transporters In The Male Human Brain"

Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Neurology / Neuroscience;  Psychology / Psychiatry
Article Date: 19 Mar 2009 - 6:00 PDT

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The findings outlined in the JAMA article "The Effects of Modafinil on Dopamine and Dopamine Transporters in the Male Human Brain" are consistent with what we already know about PROVIGIL (modafinil) Tablets [C-IV]. PROVIGIL is classified as a schedule IV medication by the DEA, which means it has some potential for abuse and dependence. It is important to note that the product label for PROVIGIL advises physicians to 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. Information about drug scheduling can be found at http://www.cephalon.com.

After 10 years on the market, millions of patients treated, as well as ongoing monitoring of abuse and diversion by Cephalon, the DEA, the FDA and other international regulatory agencies, we believe that the potential risk of abuse and dependence is accurately reflected in the product labeling. We believe that there is a low relative potential for abuse with modafinil, which is consistent with the DEA scheduling for PROVIGIL.

PROVIGIL should not be taken by healthy individuals and physicians should use appropriate caution in prescribing this medication.

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

Patients with questions about the appropriate use of PROVIGIL should contact their healthcare provider.

Serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), has been reported in adults and children taking modafinil. PROVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

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

Patients should be advised that their level of wakefulness may not return to normal. Patients should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

In clinical trials, the most frequently reported adverse events (≥5%) were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.

The U.S. Food and Drug Administration-approved prescribing information for PROVIGIL is available at http://www.PROVIGIL.com.

Source
Cephalon

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