Strattera (Atomoxetine) Age Indication for ADHD Treatment
Strattera is FDA-approved for the treatment of ADHD in children aged 6 years and older, adolescents, and adults. 1
FDA-Approved Age Range
- The FDA label explicitly states that atomoxetine is indicated for ADHD treatment in pediatric patients ages 6 to 18 years and adults. 1
- Clinical trials establishing atomoxetine's efficacy included four 6-9 week trials in pediatric patients ages 6 to 18, two 10-week trials in adults, and one maintenance trial in pediatrics ages 6 to 15. 1
Use in Children Under 6 Years (Off-Label)
- Atomoxetine use in children younger than 6 years is off-label and lacks adequate safety and efficacy data from controlled trials. 2
- For preschool-aged children (4-5 years) with ADHD, the American Academy of Pediatrics recommends behavioral therapy as first-line treatment, with methylphenidate (not atomoxetine) as the only medication with adequate evidence if pharmacotherapy becomes necessary after behavioral interventions fail. 3
- One retrospective study examined atomoxetine in 133 children aged 3-6 years with ADHD comorbid with autism spectrum disorder, finding it appeared well tolerated when titrated to 1.2-1.8 mg/kg/day, though 17.3% discontinued due to adverse events. 4 However, this represents off-label use in a specialized population and does not constitute FDA approval for this age group.
Guideline Recommendations by Age
For children ages 6-12 years (elementary and middle school-aged):
- The American Academy of Pediatrics recommends FDA-approved medications for ADHD, with atomoxetine listed as a second-line option after stimulants, with sufficient but not as strong evidence as stimulant medications. 3, 5
- Atomoxetine has established efficacy in children ages 6-18 with effect sizes of approximately 0.7 compared to stimulants with effect sizes of 1.0. 5, 6
For adolescents ages 12-18 years:
- The American Academy of Pediatrics recommends FDA-approved medications including atomoxetine as treatment options, with atomoxetine particularly useful when stimulants are contraindicated, not tolerated, or when comorbid anxiety or tic disorders are present. 3, 5
Dosing Considerations by Age
- For children and adolescents up to 70 kg body weight, atomoxetine should be initiated at approximately 0.5 mg/kg/day and increased after a minimum of 3 days to a target dose of approximately 1.2 mg/kg/day. 1
- The medication can be administered as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. 1
- Atomoxetine requires 6-12 weeks to achieve full therapeutic effect, with a median time to response of 3.7 weeks. 6, 7
Critical Safety Considerations
- The FDA black box warning states that atomoxetine increases the risk of suicidal ideation in children and adolescents with ADHD, requiring close monitoring for suicidality, clinical worsening, or unusual behavioral changes. 1
- Pooled analyses showed a 0.4% risk of suicidal ideation in atomoxetine-treated patients versus 0% in placebo-treated patients in short-term trials. 1
- Common adverse effects in pediatric patients include initial somnolence, gastrointestinal symptoms (particularly with rapid dose escalation), decreased appetite, and rare hepatitis risk. 3, 5