Modafinil improves symptoms of attention-deficit/hyperactivity disorder across subtypes in children and adolescents

J Pediatr. 2008 Mar;152(3):394-9. doi: 10.1016/j.jpeds.2007.07.052. Epub 2007 Oct 24.


Objective: This secondary analysis evaluated the efficacy of modafinil in children and adolescents by subtype of attention-deficit/hyperactivity disorder (ADHD) using pooled data from 3 double-blind, placebo-controlled studies.

Study design: The patients were boys and girls age 6 to 17 years. ADHD subtype diagnoses (ie, inattentive, hyperactive-impulsive, combined) were based on criteria published in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Patients received modafinil (170 to 425 mg) or placebo once daily for 7 to 9 weeks. Efficacy assessment used the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) School and Home Versions, Clinical Global Impression of Improvement scale (CGI-I), and Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S).

Results: A total of 638 patients received modafinil (n = 423) or placebo (n = 215). The inattentive, hyperactive-impulsive, and combined subtypes included 187 (30%), 27 (4%), and 403 (65%) patients, respectively. Modafinil (vs placebo) significantly improved mean total scores for the ADHD-RS-IV School and Home Versions for the inattentive (change from baseline: School, modafinil, -15.7, placebo, -7.1; Home, modafinil, -13.8, placebo, -5.9) and combined subtypes (School, -16.5 vs -8.8; Home, -15.7 vs -7.6). Modafinil was associated with greater improvements on the CGI-I and improved CPRS-R:S subscale scores in inattentive and combined subtypes.

Conclusions: Modafinil improved ADHD symptoms and behaviors in patients with the inattentive and combined subtypes as determined by teachers, investigators, and parents.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Age Factors
  • Attention Deficit Disorder with Hyperactivity / diagnosis*
  • Attention Deficit Disorder with Hyperactivity / drug therapy*
  • Benzhydryl Compounds / administration & dosage*
  • Central Nervous System Stimulants / administration & dosage*
  • Child
  • Confidence Intervals
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Modafinil
  • Neuropsychological Tests
  • Probability
  • Randomized Controlled Trials as Topic
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Sex Factors
  • Treatment Outcome


  • Benzhydryl Compounds
  • Central Nervous System Stimulants
  • Modafinil