When drugs are required for managing ADHD, the psychostimulants methylphenidate and dexamphetamine are first line, combined with non-drug interventions according to individual needs. The noradrenaline reuptake inhibitor atomoxetine is also effective and may be useful for people who cannot take psychostimulants because of contraindications or adverse reactions, or who do not respond to them. However, the PBS listing of atomoxetine does not include treatment for psychostimulant non-responders.
Assess and treat individual needs across multiple domains of functioning
Diagnosis by a paediatrician or psychiatrist is a requirement of the PBS authority for atomoxetine.
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Despite a lack of supporting evidence, consensus guidelines recommend that children receive multi-dimensional treatment for ADHD, involving the child, parents and teachers.4,5 Depending on the child’s individual situation, consider options including behavioural management, family education and support (e.g. respite), and developmental or educational interventions, concurrent with medication. Educational support is particularly important because there is little evidence that drug therapy has long-term benefits on academic performance.5
Atomoxetine is a noradrenaline reuptake inhibitor used for treating ADHD
Atomoxetine is a noradrenaline reuptake inhibitor that was first approved in 2002 in the USA for treating ADHD. Although it has a similar preclinical pharmacology to the antidepressant reboxetine (Edronax), there is little evidence it has efficacy as an antidepressant.
Atomoxetine reduced the symptoms of ADHD in several short-term, placebo-controlled trials in children and adolescents (age 6-18 years) and adults.6,7 These results suggest that a clinician can expect to treat 4-5 children or adolescents to see one additional response to that seen with placebo.8,9 Continuous atomoxetine also reduced the chance of relapse in trials of up to 9 months.10,11
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Safety and efficacy in children under 6 years have not been established.9
In trials of up to 2 years about 15% of 12-18-year-olds12 and about 25% of 6-7-year-olds13 withdrew because of a lack of effectiveness. Withdrawals due to adverse events were similar in both age groups, at about 5%.12,13
Methylphenidate and dexamphetamine remain first-line drug treatments for ADHD
Methylphenidate and dexamphetamine are first-line drug treatments for ADHD, as their efficacy and safety are well established, based on clinical trials and extensive use (see the NPS RADAR article on methylphenidate extended-release for more information on psychostimulant prescribing).14,15 Without more evidence it is not possible to confirm that atomoxetine is either as effective or well tolerated as psychostimulants.
The PBS listing for atomoxetine covers reimbursement for people with ADHD who cannot take psychostimulants because of a contraindication or adverse reaction. Atomoxetine is also a reasonable second-line choice for non-responders to psychostimulants, but the PBS listing does not cover this situation.
Psychostimulant non-responders may have problems in addition to ADHD, or their primary diagnosis of ADHD may need to be reconsidered before trying second-line drug therapy.5 Differential diagnoses include anxiety, depression, and learning difficulties.16
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Atomoxetine may be suitable for people with ADHD who have a history of misusing psychostimulants or other drugs (seeAtomoxetine appears to have a low potential for abuse and diversion), who have motor tics or Tourette’s syndrome, or who have an anxiety disorder.9
If psychostimulant therapy adversely affects weight, appetite or sleep, first consider reducing the dose or changing the time of dosing. Switching between dexamphetamine and methylphenidate may also be helpful.5 The PBS will only reimburse atomoxetine after both dexamphetamine and methylphenidate have been tried and permanently discontinued because of adverse effects on sleep, growth or appetite. Note that atomoxetine can also cause disturbed sleep or loss of appetite.9
Atomoxetine may be less effective than psychostimulants
Few head-to-head trials have been published comparing atomoxetine with methylphenidate or dexamphetamine, and the available data have not established that atomoxetine is similar in efficacy to psychostimulants for ADHD.17-20 One unpublished trial found that after 6 weeks of treatment 56% of participants responded to methylphenidate while 45% responded to atomoxetine, a response-rate difference of 12% (95% CI 2% to 21%).21 A smaller, open-label study found no significant difference in response rates between the two drugs.18
Evidence for effectiveness in non-responders to psychostimulants is limited
While atomoxetine may be useful for people who have not responded to psychostimulant therapy, there have been no controlled trials specifically in psychostimulant non-responders. One small series of cases found that of 7 methylphenidate non-responders, none subsequently responded to atomoxetine.22
Review the ongoing need for drug therapy
Review the management of ADHD at least annually.5 As part of this review try drug-free periods of 1-2 weeks to assess if medication is still needed, when and if individual circumstances allow it.5,23 While teachers’ reports of behaviour on and off medication are integral to assessing the ongoing need for medication, a trial off medication during school holidays may be easier as a first step.
There is no evidence from controlled trials to indicate how long atomoxetine treatment should be continued.9 In a randomised trial, children and adolescents who had been stable on atomoxetine for 1 year and who continued therapy had a relapse rate of 2% over 6 months, while those who stopped taking atomoxetine had a relapse rate of 12% (difference in relapse rates 10%, 95% CI 2% to 13%).11
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Category: WHO
