Efficacy and safety of naltrexone use in pediatric patients with autistic disorder.

OBJECTIVE: To review the efficacy and safety of naltrexone in pediatric patients with autistic disorder (AD).

DATA SOURCES: Using the terms pediatric, child, naltrexone, autism, and autistic disorder, a literature search was performed using MEDLINE (1966-May 18, 2006) and the International Pharmaceutical Abstracts (1971-May 18, 2006) database. The references of these articles were scanned for additional relevant literature.

STUDY SELECTION AND DATA EXTRACTION: All articles describing or evaluating the efficacy and/or safety of naltrexone in pediatric patients with AD were included in this review. Three case reports, 8 case series, and 14 clinical studies were identified as pertinent.

DATA SYNTHESIS: Naltrexone has been used most commonly at doses ranging from 0.5 to 2 mg/kg/day and found to be predominantly effective in decreasing self-injurious behavior. Naltrexone may also attenuate hyperactivity, agitation, irritability, temper tantrums, social withdrawal, and stereotyped behaviors. Patients may also exhibit improved attention and eye contact. Transient sedation was the most commonly reported adverse event. Small sample size, short duration, and inconsistent evaluative methods characterize the available research.

CONCLUSIONS: A child affected by AD may benefit from a trial of naltrexone therapy, particularly if the child exhibits self-injurious behavior and other attempted therapies have failed. Serious adverse effects have not been reported in short-term studies.