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 [1].
FDA-Approved Indications
This table summarizes current approved uses and dosing, according to the product’s prescribing information [2].
| Indication | Initial Dose | Titration | Target Dose | Effective Dose Range |
|---|---|---|---|---|
| Schizophrenia | ||||
| 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 |
| Bipolar Disorder | ||||
| Treatment of manic or mixed episodes | ||||
| Bipolar Mania Adults |
2-3 mg/day | 1 mg/day | 1-6 mg/day | 1-6 mg/day |
| Bipolar Mania 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. Pediatric patients |
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 |
Off-Label Uses
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 [3]. 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 [4]. 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 [3].
| Off-label Use | Evidence |
|---|---|
| Anxiety | |
| 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 |
| Dementia | |
| Overall | Moderate or high evidence of efficacy |
| Psychosis | Moderate or high evidence of efficacy |
| Agitation | Moderate or high evidence of efficacy |
| Depression | |
| Adjunctive treatment | Moderate or high evidence of efficacy |
| Eating disorders | No trials |
| Insomnia | No trials |
| Obsessive-compulsive disorder | |
| Augmentation with SSRI | Moderate or high evidence of efficacy |
| Augmentation of citalopram | Low or very low evidence of efficacy |
| Personality disorder | |
| Borderline personality disorder | No trials |
| Schizotypal personality disorder | Mixed results |
| Post-traumatic stress disorder | Moderate or high evidence of efficacy |
| Substance abuse | |
| Alcohol | No trials |
| Cocaine | Low or very low evidence of inefficacy |
| Methamphetamine | No trials |
| Methadone users | Low or very low evidence of inefficacy |
| Tourette’s syndrome | Low or very low evidence of efficacy |
Related information
References
- 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. December 2011. Available at: https://europepmc.org/article/nbk/nbk66081
- Meeks TW, Jeste DV. Beyond the Black Box: What is The Role for Antipsychotics in Dementia? Current psychiatry. 2008;7(6):50-65.
