Aripiprazole (Abilify) Use in Children
Aripiprazole is FDA-approved for use in children and adolescents for specific conditions, with established safety and efficacy data supporting its use in pediatric populations. Children as young as 6 years old can be treated with aripiprazole for certain approved indications, though dosing and monitoring requirements vary by age and condition.
FDA-Approved Pediatric Indications
- Schizophrenia in adolescents aged 13-17 years 1
- Irritability associated with autism spectrum disorder in children aged 6-17 years 2
- The FDA label specifically states: "The pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting for the differences in body weight" 1
Dosing Considerations
Schizophrenia (13-17 years)
- Starting dose: 2 mg/day, titrated to target dose
- Target dose: 10 mg/day (shown to be effective in clinical trials)
- Maximum dose: 30 mg/day (not shown to be more effective than 10 mg/day) 1
Weight-Based Considerations
- For children weighing <40 kg, dose adjustments may be necessary 1
- Children weighing ≥40 kg can generally be dosed similar to adults 1
Safety Profile in Children
Common Adverse Effects
- Weight gain (1.3-1.5 kg over 8 weeks compared to 0.3 kg with placebo) 2
- Sedation (may lead to discontinuation) 2
- Extrapyramidal symptoms (EPS) 1
- Akathisia 1
- Drowsiness 3
Serious Adverse Effects
- QTc prolongation (requires monitoring) 3
- Metabolic effects (less pronounced than with other atypical antipsychotics) 3
- Potential for prolonged toxicity even with small overdoses (case report of 10 mg ingestion in a 2-year-old causing marked lethargy, tremor, and tachycardia persisting over 72 hours) 4
Monitoring Recommendations
- Regular weight and BMI monitoring 3
- Metabolic parameter assessment (glucose, lipids) 3
- Extrapyramidal symptom evaluation using standardized scales 1
- In pediatric trials, objectively collected data showed differences between aripiprazole and placebo on the Simpson Angus Rating Scale for EPS 1
Important Considerations
- Adverse effects appear to be more pronounced in younger children (ages 6-12) compared to adolescents 3
- Lower doses (10 mg/day) have better tolerability than higher doses (30 mg/day) 5
- Long-term studies in children have shown aripiprazole to be generally well-tolerated 6
- Juvenile animal studies showed mortality, CNS effects, impaired memory/learning, and delayed sexual maturation at doses equivalent to the maximum recommended pediatric dose 1
Clinical Practice Recommendations
- Start with the lowest effective dose and titrate slowly based on response and tolerability 3
- Monitor closely for weight gain, sedation, and extrapyramidal symptoms 2
- Perform baseline and follow-up metabolic assessments 3
- Consider the risk-benefit ratio carefully, particularly for off-label uses 3
- Be aware that aripiprazole has a long half-life, which may lead to prolonged adverse effects 4
Aripiprazole represents a valuable treatment option for specific pediatric psychiatric conditions when prescribed appropriately with careful monitoring for adverse effects.