Is Risperidone approved in the USA?

Risperidone Approval Status in the USA

Risperidone is FDA-approved in the USA for multiple indications, but Okedi (the long-acting injectable formulation of risperidone) is not currently approved in the United States.

FDA-Approved Indications for Risperidone in the USA

Risperidone is approved by the FDA for several specific indications:

Adult Indications:

• Schizophrenia 1
• Acute manic or mixed episodes associated with Bipolar I Disorder (as monotherapy or as adjunctive therapy with lithium or valproate) 1

Pediatric Indications:

• Schizophrenia in adolescents aged 13-17 years 1
• Bipolar I Disorder (acute manic or mixed episodes) in children and adolescents aged 10-17 years 1
• Irritability associated with autism spectrum disorder in children and adolescents aged 5-16 years, including symptoms of aggression, self-injury, tantrums, and mood lability 1, 2

Available Formulations in the USA

Risperidone is available in the following formulations:

• Oral tablets
• Oral disintegrating tablets
• Oral solution
• Long-acting injectable (Risperdal Consta)

Important Monitoring Parameters

When prescribing risperidone, clinicians should monitor:

• Metabolic parameters: Fasting blood glucose, lipid panel, weight, BMI, and waist circumference 3

  • Weight and BMI should be measured monthly for the first 3 months, then quarterly
  • Fasting blood glucose and lipid panel should be monitored after 3 months and then annually

• Other laboratory values:

  • Complete blood count and liver function tests every 3-6 months 3
  • Prolactin levels periodically, especially if symptoms of hyperprolactinemia develop 3

• Neurological side effects:

  • Extrapyramidal symptoms, including tardive dyskinesia 1
  • Risk of tardive dyskinesia increases with duration of treatment and cumulative dose

• Common side effects requiring monitoring:

  • Weight gain (a common and potentially significant side effect) 3, 2
  • Somnolence (occurs in up to 51% of patients) 3
  • Orthostatic hypotension 2

Dosing Considerations

• Starting doses:

  • Initial dose of 0.5 mg/day is recommended for most patients 3
  • For children with autism spectrum disorder: 0.01-0.08 mg/kg/day 3

• Target doses:

  • For irritability in autism: 0.5-3.5 mg/day 3
  • For schizophrenia: 1-6 mg/day (mean modal dose: 4-5.3 mg/day) 3
  • For bipolar mania: 1-6 mg/day (mean modal dose: 3.8-5.6 mg/day) 3

Clinical Pearls

• Conservative dosing is recommended for children with autism or intellectual disability due to increased sensitivity to side effects 2, 3
• Combining risperidone with parent training is moderately more efficacious than medication alone for decreasing serious behavioral disturbance 2
• Effects on irritability in autism typically appear within 2 weeks 3
• For patients experiencing somnolence, administering the dose at bedtime or dividing the total daily dose may be helpful 3

Caution

While risperidone is effective for multiple indications, clinicians should be vigilant about monitoring for metabolic effects, weight gain, and neurological side effects to optimize the risk-benefit profile for individual patients.