Modafinil (Provigil) is a novel wakefulness-promoting agent that has been shown to have greater efficacy than placebo in the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adults. In particular, three large, drug-company sponsored trials of a film-coated formulation of modafinil (modafinil-ADHD; Sparlon) in children and adolescents with ADHD demonstrated consistent improvements in ADHD symptoms compared with placebo. Mean reductions in symptom ratings (measured using the ADHD-Rating Scale-IV school version questionnaire) ranged from 15.0 to 19.7 (7.3 to 10.1 for placebo). The most common adverse events were insomnia, headache and decreased appetite. Modafinil was generally well tolerated with most side effects considered mild to moderate in severity. Modafinil may have advantages over current therapies for ADHD in that it can be administered once daily and has fewer reinforcing properties than traditional stimulants. Modafinil could potentially be a valuable new treatment option for patients with ADHD. However, rigorous comparative studies with current first-line treatments for ADHD and longer-term independent studies are necessary before modafinil's role in the treatment of ADHD can be fully established.