STEPS

New Drug Reviews

Risperidone (Risperdal) for Management of Autistic Disorder

Am Fam Physician. 2009 Jun 15;79(12):1104-1107.

Risperidone (Risperdal) is a mixed serotonin-dopamine antagonist labeled to treat schizophrenia and mania associated with bipolar I disorder in adults. It was recently approved for the treatment of irritability associated with autistic disorder in children five to 17 years of age. Off-label uses include treatment of other symptoms of autistic disorder, including aggression, self-injurious behavior, hyperactivity, and inattention.1-3

Name Starting dosage Dose form Approximate monthly cost*

Risperidone (Risperdal)

0.25 mg per day in children weighing less than 44 lb (20 kg); 0.5 mg per day in persons weighing 44 lb or more Effective dose range of 0.5 to 3 mg per day

0.25-, 0.5-, 1-, 2-, 3-, and 4-mg tablets 0.5-, 1-, 2-, 3-, and 4-mg rapidly disintegrating tablets 1 mg per mL oral solution

$125 (0.25-mg tablets) $137 (0.5-mg tablets)


*— Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2008.

Name Starting dosage Dose form Approximate monthly cost*

Risperidone (Risperdal)

0.25 mg per day in children weighing less than 44 lb (20 kg); 0.5 mg per day in persons weighing 44 lb or more Effective dose range of 0.5 to 3 mg per day

0.25-, 0.5-, 1-, 2-, 3-, and 4-mg tablets 0.5-, 1-, 2-, 3-, and 4-mg rapidly disintegrating tablets 1 mg per mL oral solution

$125 (0.25-mg tablets) $137 (0.5-mg tablets)


*— Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2008.

SAFETY

Extrapyramidal symptoms (e.g., dyskinesia, tremor, rigidity, difficulty swallowing, akathisia), some of which require treatment, occur in up to 27.5 percent of patients and are variably reported in short-term studies of children.1,2,4 To date, studies in children have been small and of short duration; the actual likelihood of extrapyramidal symptoms is not well defined. In one study of adults receiving risperidone, only one of 31 patients developed a movement-related symptom in the form of an abnormal gait.5 Overall, risperidone was well tolerated.

Prolactin levels are increased with risperidone; however, the clinical significance of this increase is unknown because symptoms typically do not occur.4,6 Unlike haloperidol (formerly Haldol), risperidone has not been shown to increase the QT interval.7 Risperidone is U.S. Food and Drug Administration pregnancy category C.8

TOLERABILITY

Most patients (50 to 75 percent) will experience fatigue or drowsiness with risperidone.1,2 Excess salivation occurs in 10 to 27 percent of patients. Ten to 25 percent of patients exhibit weight gain, with mean increases of 5 lb, 15 oz to 6 lb, 8 oz (2.70 to 2.96 kg) in patients receiving risperidone in short-term studies (eight weeks).1,2,6 In longer-term studies (six months), average weight gain was 11 lb to 13 lb, 4 oz (5 to 6 kg).9,10

EFFECTIVENESS

As shown in short-term studies (six months or less), risperidone improves disruptive behavior symptoms associated with autistic disorder in children five to 17 years of age.13 Risperidone also improves inappropriate speech, lethargy/social withdrawal, and stereotypic behavior that often occur in children with autistic disorder.1 In adults with autistic disorder, risperidone decreases the incidence of T repetitive behavior, aggression, anxiety, and irritability, but high doses may be necessary.5

PRICE

Typical dosing of risperidone will cost approximately $125 (for the 0.25-mg tablets) or $137 (for the 0.5-mg tablets) per month. Haloperidol, which is also used to control behavior, will cost approximately $44 to $51 per month for the maximal dosage of 6 mg per day in children.

SIMPLICITY

The starting dosage of risperidone is 0.25 mg per day in children weighing less than 44 lb (20 kg), and 0.5 mg per day in persons weighing at least 44 lb.8 Depending on weight, doses may be titrated by 0.25 to 0.5 mg per day at two-week intervals, with targets of 0.5 and 1.0 mg per day. A suggested maximal dosage is approximately 1 to 3 mg per day, based on the weight of the patient.8 Patients should not mix risperidone oral solution with tea or cola because this combination can result in formation of a precipitate.11 Risperidone is also available as a rapidly disintegrating tablet that may be taken without water.

Bottom Line

Risperidone does not alter the course of autistic disorder, but is effective for controlling irritability and other associated symptoms. Patients taking risperidone should be appropriately monitored for adverse effects, especially abnormal movements. If extrapyramidal symptoms appear, therapy should be discontinued.8

Address correspondence to Kimberly A. Pesaturo, PharmD, at kimberly. pesaturo@mcphs.edu. Reprints are not available from the author.

Author disclosure: Nothing to disclose.

REFERENCES

1. Shea S, Turgay A, Carroll A, et al. Risperidone in the treatment of disruptive behavioral symptoms in children with autistic or other pervasive developmental disorders. Pediatrics. 2004;114(5):e634–e641.

2. McCracken JT, McGough J, Shah B, et al., for the Research Units on Pediatric Psychopharmacology Autism Network. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002;347(5):314–321.

3. McDougle CJ, Scahill L, Aman MG, et al. Risperidone for the core symptom domains of autism: results from the study by the autism network of the research units on pediatric psychopharmacology. Am J Psychiatry. 2005;162(6):1142–1148.

4. Luby J, Mrakotsky C, Stalets MM, et al. Risperidone in preschool children with autistic spectrum disorders: an investigation of safety and efficacy. J Child Adolesc Psychopharmacol. 2006;16(5):575–587.

5. McDougle CJ, Holmes JP, Carlson DC, Pelton GH, Cohen DJ, Price LH. A double-blind, placebo-controlled study of risperidone in adults with autistic disorder and other pervasive developmental disorders. Arch Gen Psychiatry. 1998;55(7):633–641.

6. Anderson GM, Scahill L, McCracken JT, et al. Effects of short- and long-term risperidone treatment on prolactin levels in children with autism. Biol Psychiatry. 2007;61(4):545–550.

7. Sikich L, Hamer RM, Bashford RA, Sheitman BB, Lieberman JA. A pilot study of risperidone, olanzapine, and haloperidol in psychotic youth: a double-blind, randomized, 8-week trial. Neuropsychopharmacology. 2004;29(1):133–145.

8. Risperdal (risperidone) [Product information]. Titusville, N.J: Janssen 2007http://www.risperdal.com/risperdal/shared/pi/risperdal.pdf. Accessed May 26, 2009.

9. Troost PW, Lahuis BE, Steenhuis MP, et al. Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study. J Am Acad Child Adolesc Psychiatry. 2005;44(11):1137–1144.

10. Research Units on Pediatric Psychopharmacology Autism Network. Risperidone treatment of autistic disorder: longer-term benefits and blinded discontinuation after 6 months. Am J Psychiatry. 2005;162(7):1361–1369.

11. Aki H, Okamoto Y, Kimura T. Compatibility and stability tests of risperidone with soft-drinks by isothermal titration microcalorimetry. J Therm Anal Calorim. 2006;85(3):681–684.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.


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