What is the prescribing age for Abilify (aripiprazole)?

Prescribing Age for Abilify (Aripiprazole)

Aripiprazole (Abilify) is FDA-approved for use in children aged 13 years and older for bipolar I disorder and in children aged 6 years and older for other indications such as irritability associated with autism.

Age-Specific Approvals

Aripiprazole has different approved age thresholds depending on the indication:

• Bipolar I Disorder:

  • Approved for adolescents aged 13 years and older 1
  • Specifically for moderate to severe manic episodes at a dose of 10 mg once daily for 12 weeks 1

• Other Indications:

  • Approved for children as young as 6 years for certain conditions (such as irritability associated with autism)
  • Schizophrenia: Typically approved for adolescents (13+ years)
  • Tourette's syndrome: Approved for younger children (6+ years) 2

Dosing Considerations

Adolescents (13+ years)

• Starting dose: 10 mg once daily for bipolar disorder 1
• No dosage titration is typically necessary 3
• Efficacy is usually seen within the first few weeks of treatment 3

Children (6-12 years)

• Weight-based dosing is recommended 4
• Lower doses are generally used compared to adolescents
• Tolerability is less favorable in younger children (10-12 years) compared to older adolescents 1

Weight Considerations

• Children weighing more than 40 kg may be dosed as adults 5
• For children under 40 kg, weight-based dosing should be implemented

Safety and Monitoring

Aripiprazole requires careful monitoring, particularly in younger patients:

• Common side effects in pediatric populations:

  • Sedation
  • Weight gain (though less than other atypical antipsychotics)
  • Extrapyramidal symptoms (EPS) 1

• Monitoring parameters:

  • Weight and BMI
  • Extrapyramidal symptoms
  • Metabolic parameters (glucose, lipids)
  • Efficacy and behavioral changes

Important Considerations

• Higher doses (30 mg/day) show less favorable tolerability compared to lower doses (10 mg/day) in adolescents 1
• Off-label prescriptions should be limited as they account for a significant proportion of aripiprazole use worldwide 2
• Aripiprazole has a unique pharmacologic profile as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, which may explain differences in tolerability profiles compared to other atypical antipsychotics 1

Cautions

• Adverse effects are more pronounced in children and adolescents than in adults 2
• Severe adverse effects often occur in multiple-prescription settings 2
• Post-prescription monitoring is often inadequate but essential 2
• The benefit/risk ratio should be carefully evaluated, especially for off-label use 2

When prescribing aripiprazole, always consider the FDA-approved age thresholds for specific indications, use appropriate weight-based dosing for children under 40 kg, and implement thorough monitoring protocols to ensure safety and efficacy.