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.
KeywordsMelatonin Sleep Autism spectrum disorders Dysomnia
This research was supported by grants from the York Innovations Fund and the London Law Trust. It was given ethical approval by York Research Ethics Committee and sponsored by Selby and York (North Yorkshire and York) PCT.Thanks to Than Lwin, Anne Worrall-Davies, Clare Dover, Helen Pearce and Greg Richardson for their support on the trial steering groups. Thanks also to Clive Nicholson, the trial monitor and to Chris Davey for her support with data entry.
- Buscemi, N., Vandermeer, B., Hooton, N., Pandya, R., Tjosvold, L., Hartling, L., et al. (2006). Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis. British Medical Journal, 332, 385–388.CrossRefPubMedGoogle Scholar
- Coppola, G., Iervolino, G., Mastrosimone, M., La Torre, G., Ruiu, F., & Pascotto, A. (2004). Melatonin in wake sleep disorders in children, adolescents and young adults with mental retardation with and without epilepsy: A double blind, cross over placebo controlled trial. Brain Development, 26(6), 373–376.CrossRefPubMedGoogle Scholar
- Council Directive (EC) 2001/20/EC of the European parliament and of the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.Google Scholar
- Einfield, S. L., & Tonge, B. J. (1989). The Developmental Behaviour Checklist. Melbourne Australia: Monash University Centre For Developmental Psyhciatry.Google Scholar
- Galli-Carminati, G., Deriaz, N., & Bertschy, G. (2009). Melatonin in the treatment of chronic sleep disorders in adults with autism: A retrospective study. Swiss med weekly, 139(19–20), 293–296.Google Scholar
- Goldberg, D. (1992). General health questionnaire (GHQ-12). Windsor, UK: Nfer-Nelson.Google Scholar
- Lord, C., Risi, S., Lambrecht, L., Cook, E. H., Leventhal, B. L., DiLavore, P. C., et al. (2001). The autism diagnostic observation schedule—generic: A standard measure of social and communication deficits associated with the spectrum of autism. Journal of Autism and Developmental Disorders, 30, 205–223.CrossRefGoogle Scholar
- National Autistic Society (2009, December 15th). Sleep and autism: Helping your child. Retrieved from http://www.nas.org.uk/nas/jsp/polopoly.jsp?d=528&a=3376.
- O’Connell A, Chapparo C (2002) The trouble with sleeping can a waterbed help? Inaugural World Autism Conference.Google Scholar
- Smits, M. G., Van Stel, H. F., Van Der Heijden, R., et al. (2003). Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: A randomised placebo-controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry, 42, 1286–1293.CrossRefPubMedGoogle Scholar
- WHO (1993). The ICD—10 Classification of mental and behavioural disorders:- Diagnostic Criteria for Research: General World Health Organisation.Google Scholar
- Wasdell, M. B., Jan, J. E., Bomben, M. M., Freeman, R. D., Rietveld, W. J., Tai, J., et al. (2008). A randomised, placebo-controlled trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities. Journal of Pineal Research, 44, 57–64.PubMedGoogle Scholar
- World Health Organisation (1993). The ICD – 10 Classification of Mental and Behavioural Disorders:- Diagnostic Criteria for Research: General World Health Organisation.Google Scholar