Risperidone Indications: FDA-Approved and Off-Label Uses
Risperidone is one of the oldest (and least expensive) second-generation antipsychotics. In 1993 the FDA approved it for the treatment of schizophrenia. Like most antipsychotics, risperidone is also effective for the treatment of manic and mixed episodes of bipolar I disorder. It is also one of the few antipsychotics approved for use in children .
This table summarizes current approved uses and dosing, according to the product’s prescribing information .
|Indication||Initial Dose||Titration||Target Dose||Effective Dose Range|
|Adults||2 mg/day||1-2 mg/day||4-8 mg/day||4-16 mg/day|
|Adolescents||0.5 mg/day||0.5-1 mg/day||3 mg/day||1-6 mg/day|
|Treatment of manic or mixed episodes|
|2-3 mg/day||1 mg/day||1-6 mg/day||1-6 mg/day|
Children / Adolescents
|0.5 mg/day||0.5-1 mg/day||2.5 mg/day||0.5-6 mg/day|
|Autism Spectrum Disorders|
|Irritability associated with autistic disorder.|
|0.25 mg/day (<20 kg), 0.5 mg/day ( ≥ 20kg)||0.25-0.5 mg at ≥ 2 weeks||0.5 mg/day (<20 kg), 1 mg/day ( ≥ 20kg)||0.5-3 mg/day|
There is evidence supporting the efficacy of risperidone as adjunctive treatment for major depressive disorder and for the management of behavioral disturbances and psychosis in patients suffering from dementia . However, the risk of side effects such as metabolic disturbances, weight gain, extrapyramidal symptoms and hyperprolactinemia should be kept in mind when prescribing antipsychotics as augmentation strategy.
In addition, there is a small but well-established increase in the risk of death and stroke when using second-generation antipsychotics in older adults with dementia . This led the FDA to issue a black box warning for risperidone and other antipsychotics.
The list below is based on the comparative effectiveness review by the Agency for Healthcare Research and Quality .
|Generalized anxiety disorder||Low or very low evidence of inefficacy|
|Social Phobia||No trials|
|Attention-deficit hyperactivity disorder|
|No co-occuring disorders||Low or very low evidence of efficacy|
|Bipolar Children||No trials|
|Mentally retarded children||Low or very low evidence of efficacy|
|Overall||Moderate or high evidence of efficacy|
|Psychosis||Moderate or high evidence of efficacy|
|Agitation||Moderate or high evidence of efficacy|
|Adjunctive treatment||Moderate or high evidence of efficacy|
|Eating disorders||No trials|
|Augmentation with SSRI||Moderate or high evidence of efficacy|
|Augmentation of citalopram||Low or very low evidence of efficacy|
|Borderline personality disorder||No trials|
|Schizotypal personality disorder||Mixed results|
|Post-traumatic stress disorder||Moderate or high evidence of efficacy|
|Cocaine||Low or very low evidence of inefficacy|
|Methadone users||Low or very low evidence of inefficacy|
|Tourette's syndrome||Low or very low evidence of efficacy|
- Stahl, S M. The Prescriber’s Guide. 4th ed. New York: Cambrigde University Press; 2011
- Janssen Pharmaceuticals, Inc. Risperdal prescribing information. Retrieved from http://www.janssenpharmaceuticalsinc.com/assets/risperdal.pdf. [retrieval date: April 12, 2013]
- Maglione M, Ruelaz Maher A, Hu J, Wang Z, Shanman R, Shekelle PG, Roth B, Hilton L, Suttorp MJ, Ewing BA, Motala A, Perry T. Off-Label Use of Atypical Antipsychotics: An Update. Comparative Effectiveness Review No. 43. Rockville, MD: Agency for Healthcare Research and Quality. September 2011. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm
- Meeks TW, Jeste DV. Beyond the Black Box: What is The Role for Antipsychotics in Dementia? Current psychiatry. 2008;7(6):50-65.
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