March 17, 2009
Cephalon's Provigil could carry risk of addiction, according to study data
by Mark Todoruk
Study data measuring the effects of Cephalon's sleep disorder drug Provigil (modafinil) on dopamine levels showed a potential risk for addiction in patients who took the product, according to a study published in JAMA. Lead author Nora Volkow commented that the treatment "may have more abuse potential than originally believed."
In the study, which was conducted over an eight-month period, 10 healthy adult men were given one of two dosages of Provigil, or placebo. Findings showed an increase of dopamine in patients who received the compound, and Volkow explained that this increase is "the signature for drugs that have the potential for producing addiction." The FDA-approved label for Provigil warns of potential for misuse or abuse, and the researcher noted that she is not suggesting stronger label warnings at this time. Volkow said, however, that physicians should "be alert to the possibility that [Provigil] could produce addiction."
In response to the news, Cephalon's chief scientific officer Jeffrey Vaught stated that Provigil's influence on dopamine is "weak" and "very different from amphetamines," with a low potential for abuse. Provigil is "for pathological sleep disruption, not for people who've stayed awake for 24 hours," Vaught said, adding that "to date, we've just not seen any signals that there's a problem" with addiction or abuse.
Provigil is indicated by the FDA to treat patients suffering from narcolepsy, obstructive sleep apnoea and shift-work sleep disorder. 
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