Changes in Sleep Habits during Drug Treatment of ASD

Background: Children with Autism Spectrum Disorder(ASD) are at high risk for two major family stressors: sleep disorders and problem behaviors, including irritability. A NICHD funded biomarker study of aripiprazole versus risperidone with a primary focus of treating irritability in children with autism also evaluated sleep pre and post treatment for irritability.

Objectives: (1) Using the Children’s Sleep Habits Questionnaire(CSHQ), was there a difference between the number of African Americans(AA) versus the number of Caucasians(C) with no sleep problems? (2) Did children with an IQ<70 have similar sleep scores as children with an IQ≥70? (3) Was there a difference between AA and C in IQ? (4) Did children with sleep problems differ on Aberrant Behavior Checklist(ABC) subscales from children with no sleep problems? (5) Was there a medication effect on pre versus post treatment CSHQ total scores? (6) Was there a treatment effect on sleep latency and night time awakening?

Methods: Inclusion criteria for this double-blind, placebo controlled study were children aged 6-17 with an ASD diagnosis, an ABC irritability score ≥18, and not currently taking or previously treated with aripiprazole or risperidone. Screening included developmental and medical history, the Vineland Adaptive Behavior Scale, the Autism Diagnostic Observation Schedule, the Autism Diagnostic Interview-Revised and the Stanford-Binet-5 IQ Test. Parents of children screen positive for ASD completed the CSHQS and the ABC before children were randomized to drug treatment and at study completion.

Results: This preliminary study included 45 children, 60% C and 40%AA. There was no difference in the number of AA versus C with a sleep score <41. Mean pre-post study sleep scores of AA children did not differ from those of C children. Sleep scores for children with an IQ<70 versus those with IQ≥70 were not statistically different. There was no difference between the mean IQ of C and AA children. By ANOVA, the ABC Lethargy, Stereotypy, Hyperactivity and Inappropriate Speech subscale scores did not differ between children with sleep versus no sleep problems. A difference in the Irritability subscale score in sleep versus no sleep problems approached significance (F=3.34, p=0.07). For the total sample of children on aripiprazole or risperidone, the pre-drug sleep score was significantly worse than the post-drug score, t(44)=5.01, p<0.00l). CSHQ total mean scores of children on aripiprazole(n=23) versus risperidone(n=22) were compared. Risperidone performed significantly better than aripiprazole in addressing sleep disturbance, t(31.11)=2.11, p<0.04). The two drugs did not differ in treatment of CSHQ sleep latency or night time awakening scores. Pre-drug sleep latency scores were significantly worse than post-drug scores, t(44)=-3.07, p<0.0036. There was a trend towards significance for decreased night-time awakening post treatment, t(44)=179, p<0.08.

Conclusions: In children with high irritability, problems with sleep versus no sleep problems approached significance. Sleep scores for children with IQ<70 versus those with IQ≥70 were not statistically different. Both medications significantly reduced CSHQ problems with sleep. Risperidone performed significantly better than aripiprazole overall. However, there was no difference between the two in improved outcome for sleep latency and a trend for decreased night-time awakening.