Committee Votes Against Accepting Modafinil for ADHD
The FDA’s Psychopharmacologic Drugs Advisory Committee has voted not to recommend approval of modafinil tablets (Sparlon, Cephalon), an investi-gational medication for children and adolescents with ADHD. Cephalon had received an approvable letter from the FDA in October 2005. Modafinil was deemed effective for its intended use, but more safety data were needed.
Sparlon is a new formulation and dosage strength of modafinil, the active ingredient in Provigil, which is indicated for adults with excessive sleepiness associated with narcolepsy, sleep apnea, and shiftwork sleep disorder. Sparlon is chemically distinct from currently approved therapies.
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Provigil is not approved to treat ADHD; it is available only in 100- and 200-mg strengths. Sparlon should not be used in combination with Provigil or any other medications that contain modafinil.
