Atomoxetine hydrochloride for the treatment of attention-deficit/hyperactivity disorder

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) occurs in approximately 3% to 10% of the pediatric population. Most of the drugs typically used to treat ADHD are stimulants, which, because of their addictive properties and potential for abuse, are controlled substances. Although these drugs are the mainstay of treatment for ADHD, nearly one third of patients may not respond to or be able to tolerate them. Atomoxetine hydrochloride, a nonstimulant approved by the US Food and Drug Administration for the treatment of ADHD, may provide an alternative to the use of stimulants. OBJECTIVE: The goal of this review was to describe the chemistry, mechanism of action, pharmacokinetics, drug interactions, and efficacy and safety profiles of atomoxetine in pediatric and adult patients with ADHD, as well as relevant pharmacoeconomic considerations. METHODS: Relevant publications were identified through a search of the English-language literature indexed on PreMEDLINE and MEDLINE (1966-May 2003) using the search terms atomoxetine, tomoxetine, and LY139603. These terms were also applied to the Google search engine. All articles were reviewed for suitability for inclusion. The manufacturer of atomoxetine provided both published and unpublished data. RESULTS: In the data reviewed, atomoxetine was more efficacious than placebo in patients with ADHD (P<0.05 to P<0.01). Therapeutic doses ranged from 45 mg or placebo (P<0.05). These results add support to the hypothesis that atomoxetine may not cause the increase in dopamine concentrations in the nucleus accumbens that is associated with pleasurable effects and abuse potential.