Strattera (Atomoxetine) Dosage and Treatment Guidelines for ADHD
For patients with ADHD, Strattera (atomoxetine) should be initiated at 0.5 mg/kg/day and titrated after a minimum of 3 days to a target dose of 1.2 mg/kg/day, with a maximum recommended dose of 1.4 mg/kg/day or 100 mg daily, whichever is less. 1
Age-Specific Recommendations
Preschool Children (4-5 years)
- Atomoxetine is not recommended as first-line treatment for preschool-aged children 2
- Evidence-based parent and/or teacher-administered behavior therapy should be prescribed as first-line treatment 2
- Atomoxetine has not received sufficient rigorous study in this population and is not recommended for children under 6 years 1
Elementary School-Aged Children (6-11 years)
- FDA-approved medications for ADHD, including atomoxetine, are recommended along with behavioral therapy 2
- Atomoxetine is considered sufficient but less strong than stimulants in efficacy (after stimulants, atomoxetine, extended-release guanfacine, and extended-release clonidine, in that order) 2
- Initial daily dose: 0.5 mg/kg/day 1, 3
- Target daily dose: 1.2 mg/kg/day 1, 3
- Maximum daily dose: 1.4 mg/kg/day or 100 mg daily, whichever is less 1, 3
Adolescents (12-18 years)
- FDA-approved medications for ADHD, including atomoxetine, are recommended with the adolescent's assent 2
- For adolescents weighing up to 70 kg, follow the same weight-based dosing as for children 3
- For adolescents over 70 kg, use adult dosing: initial 40 mg/day, target 80 mg/day, maximum 100 mg/day 3
- Consider atomoxetine particularly in adolescents at risk for substance abuse due to its negligible abuse potential 2, 4
Administration Guidelines
- Can be administered either as a single daily dose or split into two evenly divided doses 4, 5
- A single morning dose has been shown to be effective throughout the day and into the evening 6
- Titrate doses to achieve maximum benefit with minimum adverse effects 2
- For patients with hepatic impairment or those taking strong CYP2D6 inhibitors, dosage adjustments are necessary 3
Monitoring and Safety Considerations
Required Monitoring
- Monitor closely for suicidality, clinical worsening, and unusual behavior changes, especially during the first few months of treatment or with dose changes 1, 3
- Monitor for adverse effects including decreased appetite, somnolence, gastrointestinal symptoms, and fatigue 1
- Monitor growth as atomoxetine has been linked to growth delays in the first 1-2 years of treatment 1
- Monitor heart rate and blood pressure, as atomoxetine can cause statistically significant increases in both 4
Important Safety Warnings
- Atomoxetine carries an FDA black box warning for increased risk of suicidal ideation in children and adolescents 1, 3
- Severe liver injury may occur; discontinue and do not restart in patients with jaundice or laboratory evidence of liver injury 3
- Perform cardiac evaluation if risk factors are present before starting treatment 1
- Contraindicated in patients with narrow-angle glaucoma, pheochromocytoma, or severe cardiovascular disorders 3
Special Considerations
- Atomoxetine is particularly useful for patients at risk of substance abuse, as well as those with co-morbid anxiety or tics 4, 5
- Unlike stimulants, atomoxetine is not a controlled substance in the US 4, 5
- Atomoxetine may be less likely than methylphenidate to exacerbate disordered sleep 4
- Discontinuation of atomoxetine is not associated with symptom rebound 4, 6