Melatonin Versus Placebo in Children with Autism Spectrum Conditions and Severe Sleep Problems Not Amenable to Behaviour Management Strategies: A Randomised Controlled Crossover Trial

Abstract

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.

The use of MElatonin in children with Neurodevelopmental Disorders and impaired Sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS).

“…In the study by Wirojanan et al, 18 entry depended exclusively on parents reporting a sleep disorder. In the study by Wright et al, 68 children were included who manifested any type of sleep problem that persisted after a behavioural intervention. In the study by Garstang et al, 69 children were required to have a sleep latency of > 1 hour for inclusion.…”

“…68 The children received either melatonin (0.05 mg/kg, 0.1 mg/kg and 0.15 mg/kg) or placebo for 1 week (to allow some comparison of dose ranges, an average 9-year-old boy in MENDS on this regime weighing 30 kg would receive 1.5 mg, 3 mg or 4.5 mg, and no child would have received the 6-mg or 12-mg MENDS dose). The authors did not include sleep duration in their results having previously shown that this does not change in this group of children.…”

Complementary Medicine Products Used in Autism - Evidence for Efficacy and Safety

“…In the randomised controlled trial in 17 children with autism by Wright et al (2011) adverse effects were low and similar between the two arms. The side effects that occurred more frequently in the melatonin arm were as follows: daytime drowsiness, reduced appetite, reduced alertness and diarrhoea however, differences in the frequency of these adverse effects were not statistically significant.…”

“…One survey found 25%of medical practitioners reported they recommend melatonin as a treatment in autism (Golnik&Ireland 2009) As summarised in Table 2, two randomised controlled trials (n=7 & 17) have been performed in autism that suggest melatonin is effective at reducing sleep latency, or time taken for initiation of sleep, and total sleep time in children with sleep problems and autism (Garstang&Wallis 2006;Wright et al 2011). Further, one of the trials also showed melatonin improved the number of wakings per night (Garstang&Wallis 2006) and the other showed it improved daytime behaviour (Wright et al 2011). Therefore on the basis of the findings in the two randomised controlled trials, melatonin is assigned to category B of the Natural Standard Research Collaboration grading rationale as shown in Table 1.…”

Complementary Medicine Products Used in Autism - Evidence for Rationale

“…Sleep problems in children with ASD are common with a prevalence of 44-83% in comparison to 10-20% of typically developing young children (Wright et al 2011). Sleep difficulties contribute to significant morbidity in children and to family stress.…”