Is Risperidone (atypical antipsychotic) used in the USA?

Risperidone Use in the USA

Yes, risperidone is widely used in the USA as an FDA-approved atypical antipsychotic medication for multiple psychiatric conditions. 1

FDA-Approved Indications in the USA

Risperidone is FDA-approved for the following conditions:

• Schizophrenia:

  • Adults (all formulations)
  • Adolescents aged 13-17 years (1-6 mg/day) 1

• Bipolar I Disorder:

  • Acute manic or mixed episodes in adults (monotherapy)
  • Acute manic or mixed episodes in children and adolescents aged 10-17 years (monotherapy)
  • Adjunctive therapy with lithium or valproate in adults 1

• Irritability Associated with Autism Spectrum Disorder:

  • Children and adolescents aged 5-16 years
  • Specifically for symptoms of aggression, self-injury, tantrums, and quickly changing moods 1, 2

Dosing Guidelines

Dosing varies by indication and age:

• Schizophrenia:

  • Adults: 1-6 mg/day (mean modal dose: 4-5.3 mg/day)
  • Adolescents: 1-6 mg/day 2

• Bipolar Mania:

  • Adults: 1-6 mg/day (mean modal dose: 4.1-5.6 mg/day as monotherapy)
  • Children (10-17 years): 0.5-2.5 mg/day (recommended target dose) 1

• Autism-Related Irritability:

  • Weight-based dosing:
    • <20 kg: Start at 0.25 mg/day, target 0.5 mg/day
    • ≥20 kg: Start at 0.5 mg/day, target 1 mg/day
  • Effective dose range: 0.5-3 mg/day 1

Additional Off-Label Uses in the USA

Risperidone is also commonly used off-label for:

• PTSD-related nightmares (1-3 mg/day) 3, 2
• Irritability, aggression, and problem behaviors in youth with intellectual disability 3, 2
• Treatment-resistant obsessive-compulsive disorder (as augmentation) 4

Side Effects and Monitoring

Key side effects requiring monitoring include:

• Weight gain: Most common significant problem, especially in children and adolescents 3, 2
• Extrapyramidal symptoms: Less common than with traditional antipsychotics, but risperidone appears to have the highest risk among atypical agents 3, 2
• Metabolic effects: Requires monitoring of fasting glucose, lipids, BMI, and blood pressure 2
• Prolactin elevation: Can lead to galactorrhea, gynecomastia, and sexual dysfunction 2
• Sedation: Common side effect, especially at initiation 3, 2
• Orthostatic hypotension: Requires monitoring, especially at treatment initiation 3, 2

Clinical Considerations

When prescribing risperidone in the USA, clinicians should:

1. Start with low doses and titrate slowly based on response and tolerability
2. Monitor weight, metabolic parameters, and extrapyramidal symptoms regularly
3. Consider the risk-benefit profile, particularly in children and adolescents
4. For maintenance therapy, periodically reassess the need for continued treatment 1

Risperidone's availability in the USA as both brand name (Risperdal) and generic formulations has made it one of the most widely prescribed atypical antipsychotics, included on the World Health Organization's List of Essential Medicines for its balance of efficacy, safety, tolerability, and cost-effectiveness 5.