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Spotlight on Atomoxetine in Adults with Attention-Deficit Hyperactivity Disorder

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Abstract

Atomoxetine (Strattera™) is a selective noradrenaline (norepinephrine) reuptake inhibitor and nonstimulant that has shown greater efficacy than placebo in attention-deficit hyperactivity disorder (ADHD) in adults. In two large, well controlled, 10-week trials in adults with ADHD, improvements in ADHD symptoms, as assessed by investigator- and patient-rated scores, were greater with oral atomoxetine (60, 90 or 120 mg/day) than with placebo. Mean reductions in the total ADHD symptom score on the investigator-rated Conners’ Adult ADHD Rating Scale (CAARS) in atomoxetine versus placebo recipients were 28.3% versus 18.1% and 30.1% versus 19.6%, respectively. Mean reductions in the scores on the Clinician Global Impression of Severity Scale, patient-rated CAARS and Wender-Reimherr Adult Attention Deficit Disorder Scale were also significantly greater with atomoxetine than with placebo. Continued efficacy was demonstrated in a noncomparative, 34-week extension phase.

Atomoxetine was generally well tolerated in clinical trials; withdrawal rates due to adverse events in atomoxetineversus placebo-treated patients participating in the two major trials were 7.8% versus 4.3% and 9.3% versus 2.4% (p < 0.05 for the latter trial). Adverse events reported significantly more frequently with atomoxetine than placebo included dry mouth, insomnia, nausea, decreased appetite, constipation, dizziness, sweating, dysuria, sexual problems and palpitations. Modest increases in heart rate and blood pressure were well tolerated and gradually decreased on cessation of treatment. Atomoxetine was not associated with QT interval prolongation.

Atomoxetine can be administered once or twice daily. Its subjective-effects profile is different to that of methylphenidate and atomoxetine is not associated with abuse or diversion; it is therefore not a controlled substance in the US. This also means repeat prescriptions during long-term treatment can be more conveniently processed.

Conclusion: Atomoxetine is an effective and generally well tolerated treatment for adults with ADHD. It is a nonstimulant and is the first ADHD treatment to be approved specifically for adult use based on its efficacy in well controlled adult trials. It can be administered as a single daily dose or split into two evenly divided doses. It carries negligible risk of abuse or diversion and is not a controlled substance. Atomoxetine is a valuable new treatment option for adults with ADHD and is particularly useful in patients who are at risk for substance abuse or who do not wish to take a controlled substance.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

The full text article in Drugs 2003; 64 (2): 205-222 was reviewed by: P.J. Ambrosini, Eastern Pennsylvania Psychiatric Institute, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA; J. Elia, Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA; J.H. Newcorn, Department of Psychiatry, Mount Sinai Medical Center, New York, New York, USA; F. Reimherr, Department of Psychiatry, University of Utah Health Sciences Center, Salt Lake City, Utah, USA; M. Weiss, Children’s and Women’s Health Centre of British Columbia, Vancouver, British Columbia, Canada.

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  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland, 1311, New Zealand

    Dene Simpson & Greg L. Plosker

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  1. Dene Simpson
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  2. Greg L. Plosker
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Correspondence to Dene Simpson.

Additional information

This Spotlight is derived from abstract and summary text of an Adis Drug Evaluation originally published in full in Drugs 2003; 64 (2): 205–222. Reviewers of the original full text article are listed in the Acknowledgments section.

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Simpson, D., Plosker, G.L. Spotlight on Atomoxetine in Adults with Attention-Deficit Hyperactivity Disorder. CNS Drugs 18, 397–401 (2004). https://doi.org/10.2165/00023210-200418060-00011

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