The efficacy of melatonin for sleep problems in children with autism, fragile X syndrome, or autism and fragile X syndrome.
OBJECTIVE
To determine the efficacy of melatonin on sleep problems in children with autistic spectrum disorder (ASD) and fragile X syndrome (FXS).


METHODS
A 4-week, randomized, double blind, placebo-controlled, crossover design was conducted following a 1-week baseline period. Either melatonin, 3 mg, or placebo was given to participants for 2 weeks and then alternated for another 2 weeks. Sleep variables, including sleep duration, sleep-onset time, sleep-onset latency time, and the number of night awakenings, were recorded using an Actiwatch and from sleep diaries completed by parents. All participants had been thoroughly assessed for ASD and also had DNA testing for the diagnosis of FXS.


RESULTS
Data were successfully obtained from the 12 of 18 subjects who completed the study (11 males, age range 2 to 15.25 years, mean 5.47, SD 3.6). Five participants met diagnostic criteria for ASD, 3 for FXS alone, 3 for FXS and ASD, and 1 for fragile X premutation. Eight out of 12 had melatonin first. The conclusions from a nonparametric repeated-measures technique indicate that mean night sleep duration was longer on melatonin than placebo by 21 minutes (p = .02), mean sleep-onset latency was shorter by 28 minutes (p = .0001), and mean sleep-onset time was earlier by 42 minutes (p = .02).


CONCLUSIONS
The results of this study support the efficacy and tolerability of melatonin treatment for sleep problems in children with ASD and FXS.
Wirojanan
Juthamas
J
Medical Investigation of Neurodevelopmental Disorders (M.I.N.D.) Institute, University of California Davis Health System, Sacramento, CA 95817, USA.
Jacquemont
Sebastien
S
Diaz
Rafael
R
Bacalman
Susan
S
Anders
Thomas F
TF
Hagerman
Randi J
RJ
Goodlin-Jones
Beth L
BL
D000293:Adolescent; D001321:Autistic Disorder / Q000150:complications*; D002492:Central Nervous System Depressants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005600:Fragile X Syndrome / Q000150:complications*; D006801:Humans; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D012893:Sleep Wake Disorders / Q000150:complications / Q000188:drug therapy*
D002492:Central Nervous System Depressants; D008550:Melatonin