Age Range for Strattera (Atomoxetine) in ADHD
Strattera (atomoxetine) is FDA-approved for the treatment of ADHD in children aged 6 years and older, adolescents, and adults, with no upper age limit specified. 1
FDA-Approved Age Range
- Minimum age: 6 years – Atomoxetine is approved for children starting at age 6 years 1
- Maximum age: No upper limit – The medication is approved for adolescents and adults without age restriction 1, 2
- Pediatric dosing applies to children and adolescents up to 70 kg body weight, starting at approximately 0.5 mg/kg/day and increasing after a minimum of 3 days to a target dose of approximately 1.2 mg/kg/day 1
Age-Specific Guideline Recommendations
Children Ages 6–11 Years (Elementary School)
- The American Academy of Pediatrics recommends FDA-approved medications for ADHD in this age group, with atomoxetine having sufficient but less strong evidence compared to stimulants 3
- Atomoxetine should be prescribed together with evidence-based parent training and/or behavioral classroom interventions 3
Adolescents Ages 12–17 Years
- Atomoxetine is FDA-approved through age 17 years and should be prescribed with the adolescent's assent 3
- The medication remains an appropriate option when stimulants are contraindicated or not tolerated 4, 5
Adults (18 Years and Older)
- Atomoxetine is the only FDA-approved non-stimulant specifically studied and approved for adult ADHD based on well-controlled adult trials 2
- Target dose for adults is 60–100 mg daily, with a maximum of 1.4 mg/kg/day or 100 mg/day, whichever is lower 1, 2
Use Outside Approved Age Range
Preschool Children (Ages 3–5 Years)
- Atomoxetine is NOT FDA-approved for children younger than 6 years 1
- Limited retrospective data exist for children aged 3–6 years with ADHD and comorbid autism spectrum disorder, showing that atomoxetine appeared well tolerated when titrated to 1.2–1.8 mg/kg/day, though 17.3% discontinued due to adverse events 6
- For preschool-aged children (ages 4–5 years), behavioral therapy should be first-line treatment; dexamphetamine is the sole FDA-approved medication for children younger than 6 years—guanfacine and atomoxetine are not approved for this age group 7
Clinical Positioning by Age
- Ages 6–17 years: Atomoxetine is positioned as a second-line option after stimulant failure or when stimulants are contraindicated, particularly useful for patients with comorbid anxiety, tics, or substance abuse risk 4, 5
- Adults: Atomoxetine represents a valuable first-line alternative to stimulants, especially for those at risk of substance abuse or who prefer a non-controlled substance 2
Important Safety Considerations Across All Ages
- Black-box warning for suicidal ideation in children and adolescents – Close monitoring is required, particularly during the first few months of treatment 1
- Atomoxetine requires 6–12 weeks to achieve full therapeutic effect, significantly longer than stimulants which work within days 5, 2
- Effect sizes are approximately 0.7 compared to stimulants (1.0), indicating moderate efficacy 4, 5