Melatonin versus placebo in children with autism spectrum conditions and severe sleep problems not amenable to behaviour management strategies: a randomised controlled crossover trial.
Twenty-two children with autism spectrum disorders who had not responded to supported behaviour management strategies for severe dysomnias entered a double blind, randomised, controlled crossover trial involving 3 months of placebo versus 3 months of melatonin to a maximum dose of 10 mg. 17 children completed the study. There were no significant differences between sleep variables at baseline. Melatonin significantly improved sleep latency (by an average of 47 min) and total sleep (by an average of 52 min) compared to placebo, but not number of night wakenings. The side effect profile was low and not significantly different between the two arms.
Lime Trees Child, Adolescent and Family Unit, 31 Shipton Road, York, North Yorkshire, YO30 5RE, England, UK. barry.wright@nyypct.nhs.uk
Barry
B
Wright
David
D
Sims
Siobhan
S
Smart
Ahmed
A
Alwazeer
Ben
B
Alderson-Day
Victoria
V
Allgar
Clare
C
Whitton
Heather
H
Tomlinson
Sophie
S
Bennett
Jenni
J
Jardine
Nicola
N
McCaffrey
Charlotte
C
Leyland
Christine
C
Jakeman
Jeremy
J
Miles
D000293:Adolescent; D002492:Central Nervous System Depressants / Q000627:therapeutic use*; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000150:complications*; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D012893:Sleep Wake Disorders / Q000150:complications / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D002492:Central Nervous System Depressants; D008550:Melatonin