• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
Pediatric Labeling Date:  08/17/2007
Trade Name:  Provigil
Generic Name or Proper Name (*):  modafinil
Indications Studied:  Narcolepsy
Label Changes Summary:  * Modafinil is not approved for use in pediatric patients for any indication * Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy * 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 * In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation * Information on safety, AEs and clinical study
Product Labeling:  Labeling  Opens a new window
Sponsor:  Cephalon, Inc
Pediatric Exclusivity Granted Date:  03/21/2006
Therapeutic Category:  CNS Stimulant