Is modafinil used in the treatment of attention deficit hyperactivity disorder (ADHD)?

Updated: Nov 20, 2018
  • Author: Maggie A Wilkes, MD; Chief Editor: Caroly Pataki, MD  more...
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Answer

In August 2006, Cephalon, the manufacturer of modafinil (Sparlon), received a nonapprovable letter from the FDA for the treatment of ADHD (ADD). Cephalon has decided that it will not pursue further development of Sparlon for ADHD (ADD). Modafinil is still available as Provigil, which does have FDA approval to improve wakefulness for adults with narcolepsy, sleep apnea, or shift-work sleep disorders. Many ADHD (ADD) specialists continue to use modafinil in selected patients without problems. To view information from a media briefing describing the FDA decision, see Cephalon Media Briefing.

Transcripts of the FDA Psychopharmacologic Drugs Advisory Committee minutes that describe the rashes observed in clinical trials with modafinil are available. For more information see FDA Psychopharmacologic Drugs Advisory Committee minutes from March 23, 2006 that discuss modafinil for ADHD.


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