Melatonin for Sleep in Children With Autism

Inclusion Criteria

• •Children with autism ages 4-10 years.
• •Diagnosis of autism based on Autism Diagnostic Observation Schedule (ADOS).
• •Time to fall asleep of 30 minutes or longer by parent report at least 3 nights/week in the last 3 months.
• •Children may take seasonal allergy medications.
• •Children may take the following medications for the same dose at least 3 months: Citalopram (Celexa), Escitalopram (Lexapro), Amphetamine-dextroamphetamine (Adderall), Atomoxetine (Strattera), Methylphenidate(Ritalin), Dextroamphetamine(Dexedrine), Risperidone (Risperdal.
• •Children with primary sleep disorder other than insomnia (such as sleep-disordered breathing).
• •Children with non-febrile unprovoked epileptic seizure within the last two years.
• •Children with liver disease or high fat diets, as melatonin metabolism may be affected in these children.
• •Children who are visually impaired (partially or completely blind) as light suppresses melatonin synthesis and these children may have altered diurnal melatonin rhythms.
• •Children with known genetic syndromes co-morbid with autism including fragile X, Down syndrome, neurofibromatosis, or tuberous sclerosis.
• •Children who have outside normal limits on blood work for complete blood count, liver and renal function and hormone levels of ACTH, cortisol, LH, FSH, prolactin, testosterone and estradiol.
• •Tanner staging beyond level 1 at any time point in the study.
• •Children whose assessment score does not place them on the autism spectrum.