What is the recommended dosing and treatment plan for Strattera (atomoxetine) in patients with Attention Deficit Hyperactivity Disorder (ADHD)?

Recommended Dosing and Treatment Plan for Strattera (Atomoxetine) in ADHD

The recommended dosing for Strattera (atomoxetine) in ADHD is to start at 0.5 mg/kg/day and titrate to a target dose of 1.2 mg/kg/day (maximum 1.4 mg/kg/day or 100 mg daily, whichever is less) for optimal efficacy and tolerability. 1

Initial Dosing Strategy

For children and adolescents:

• Weight ≤70 kg:

  • Initial dose: 0.5 mg/kg/day
  • Target dose: 1.2 mg/kg/day
  • Maximum dose: 1.4 mg/kg/day 1

• Weight >70 kg and adults:

  • Initial dose: 40 mg/day
  • Target dose: 80 mg/day
  • Maximum dose: 100 mg/day 1

Titration Schedule

• Dose should be adjusted every 7-14 days based on clinical response and tolerability 2
• Titration sequence: Start at initial dose → increase to 60 mg → then 80 mg as needed 2
• The 1.8 mg/kg/day dose does not provide additional benefit over the 1.2 mg/kg/day dose, while the 0.5 mg/kg/day dose is not superior to placebo for initial treatment 1, 3

Administration Options

• Can be administered as a single daily dose in the morning or divided into two evenly divided doses (morning and late afternoon) 1
• Once-daily morning dosing has been shown to be effective with effects lasting into the evening 4
• Administration can be with or without food

Monitoring and Follow-up

• Regular assessment of blood pressure and heart rate is necessary as atomoxetine can cause modest increases in these parameters 4, 5
• Monitor weight and height in pediatric patients as atomoxetine may cause initial weight loss and growth slowing 4
• Liver function should be monitored due to rare but serious risk of liver injury 1
• Screen for suicidal ideation, particularly in children and adolescents (black box warning) 1
• Follow-up appointments should be scheduled at least monthly until symptoms are stabilized 2

Maintenance Treatment

• For patients with robust response to initial treatment, a lower maintenance dose of 0.5 mg/kg/day may be effective for long-term management 6
• Long-term efficacy has been demonstrated in maintenance studies 4

Special Considerations

Hepatic Impairment

• Dose adjustment is required for patients with hepatic impairment 1

CYP2D6 Status

• Dose adjustment is necessary for poor CYP2D6 metabolizers or patients taking strong CYP2D6 inhibitors 1
• Poor metabolizers have greater exposure to and slower elimination of atomoxetine 4

Comorbidities

• Atomoxetine may be particularly beneficial for patients with:
  • Anxiety disorders 7
  • Tic disorders/Tourette's syndrome 7
  • History or risk of substance abuse (atomoxetine has negligible abuse potential) 4, 5

Advantages of Atomoxetine

• Not classified as a controlled substance, making prescription management easier 4, 5
• Can be administered once daily 1
• Negligible risk of abuse or misuse 4, 5
• May have fewer sleep disturbances compared to stimulants 4

Common Side Effects

• Most common: headache, abdominal pain, decreased appetite, vomiting, somnolence, and nausea 4
• Most side effects are mild to moderate in severity 4
• Discontinuation rates due to adverse events are generally low (<5% in clinical trials) 3

Important Precautions

• Black box warning for increased risk of suicidal ideation in children and adolescents 1
• Risk of serious liver injury (rare) 1
• Cardiovascular effects: increases in heart rate and blood pressure 1, 4
• Screen for bipolar disorder before initiating treatment 1
• Monitor for emergence of aggressive behavior or hostility 1

Atomoxetine has demonstrated efficacy in both short-term and long-term treatment of ADHD, with improvements in core ADHD symptoms and quality of life measures 1, 4. While it may be less effective than some extended-release stimulants, it offers an important non-stimulant option for ADHD treatment, particularly for patients with specific comorbidities or concerns about stimulant use 4.