Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders

Inclusion Criteria:

- Both male and female children

- Ages 4 to 17 1/2 years

- Diagnosis with Autism Spectrum Disorder on the basis of the clinical judgment of an
autism specialist, preferably using the Autism Diagnostic Observation Schedule or the
Autism Diagnostic Interview-Revised.

Exclusion Criteria:

- Abnormal electroencephalogram in the past month

- Cardiovascular problems

- Asthma

- Respiratory disease

- Peptic ulcer disease

- Renal or hepatic dysfunction (abnormal blood urea nitrogen/creatinine or 2 times
elevated liver transaminases)

- Urinary tract obstruction

- Underweight (body mass index < 5th percentile compared to age and sex matched
population)

- Other serious illness

- Use of any of the following drugs that might interact with study medications
(anticholinergics, systemic corticosteroids, phenobarbital, peginterferon,
beta-blockers or any drug that may cause arrhythmias). Drugs that induce or inhibit
cytochrome P450 2D6 and cytochrome P450 3A4 (enzymes important for drug metabolism)
will be allowed because any effects of such medications are likely to be lost in
individual variability due to genetic polymorphisms.

- Use of medications affecting sleep (including melatonin or donepezil). Children on
these will have to discontinue them for 4 weeks before enrollment in the trial in
order to establish an appropriate behavioral baseline, and agree to discontinue use
for the duration of the trial.

- Pregnancy and lactation