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document
The efficacy of melatonin for sleep problems in children with autism , fragile X syndrome , or autism and fragile X syndrome . STUDY 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 ) . CONCLUSION The results of this study support the efficacy and tolerability of melatonin treatment for sleep problems in children with ASD and FXS .
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Intervention_Pharmacological
melatonin
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Intervention_Pharmacological
melatonin
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Intervention_Pharmacological
melatonin
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Intervention_Control
placebo
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Intervention_Pharmacological
melatonin
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Intervention_Pharmacological
melatonin
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Intervention_Control
placebo
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Intervention_Pharmacological
melatonin
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Outcome_Physical
Sleep variables
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Outcome_Other
sleep duration , sleep-onset time , sleep-onset latency time , and the number of night awakenings
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Outcome_Other
mean night sleep duration
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Outcome_Other
mean sleep-onset latency
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Outcome_Other
mean sleep-onset time
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Participant_Condition
sleep problems
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Participant_Age
children
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Participant_Sample-size
12
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Participant_Sample-size
18
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Participant_Sample-size
11
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Participant_Age
2 to 15.25 years
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Participant_Sample-size
Five
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Participant_Sample-size
Eight
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Participant_Sample-size
12