Melatonin for Sleep in Children with Autism: A Controlled Trial Examining Dose, Tolerability, and Outcomes
- 2.3k Downloads
Supplemental melatonin has shown promise in treating sleep onset insomnia in children with autism spectrum disorders (ASD). Twenty-four children, free of psychotropic medications, completed an open-label dose-escalation study to assess dose–response, tolerability, safety, feasibility of collecting actigraphy data, and ability of outcome measures to detect change during a 14-week intervention. Supplemental melatonin improved sleep latency, as measured by actigraphy, in most children at 1 or 3 mg dosages. It was effective in week 1 of treatment, maintained effects over several months, was well tolerated and safe, and showed improvement in sleep, behavior, and parenting stress. Our findings contribute to the growing literature on supplemental melatonin for insomnia in ASD and inform planning for a large randomized trial in this population.
KeywordsMelatonin Insomnia Actigraphy Clinical trial Children’s sleep habits questionnaire Child behavior checklist Autism diagnostic observation schedule
This work was supported by NICHD (RO1 HD59253), Autism Speaks, Vanderbilt General Clinical Research Center (M01 RR-00095 from the National Center for Research Resources, National Institutes of Health), and by the Vanderbilt University Kennedy Center (NICHD HD15052). Natrol®, (Chatsworth, CA) provided study drug but no other support. Dr. Shlomo Shinnar provided valuable input into the study design and Dr. Gregory Barnes served as the medical safety monitor. We acknowledge Ms. Kyla Surdyka and Ms. Meg Touvelle for their assistance with data entry, and are appreciative to the families who participated in this project.
- Abidin, R. R. (1995). Parenting stress index (3rd ed.). Odessa, FL: Psychological Assessment Resources.Google Scholar
- Achenbach, T. M., & Rescorla, L. A. (2001a). Manual for the ASEBA preschool forms and profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, and Families.Google Scholar
- Achenbach, T. M., & Rescorla, L. A. (2001b). Manual for the ASEBA school age forms and profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, and Families.Google Scholar
- Adkins, K. W., Goldman, S.E., Fawkes, D., Surdyka, K., Wang, L., & Song, Y. et al. (in press). A pilot study of shoulder placement for actigraphy in children. Behavioral Sleep Medicine.Google Scholar
- American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders, 4th edn, Text Revision. Washington DC: American Psychiatric Association.Google Scholar
- Carpay, J. A., Arts, W. F. M., Vermeulen, J., Stroink, H., Brouwer, O. F., Peters, A. C. B., et al. (1996). Parent-completed scales for measuring seizure severity and severity of side-effects on antiepileptic drugs in childhood epilepsy: Development and psychometric analysis. Epilepsy Research, 24, 173–181.PubMedCrossRefGoogle Scholar
- Couturier, J. L., Speechley, K. N., Steele, M., Norman, R., Stringer, B., Nicholson, R., et al. (2005). Parental perception of sleep problems in children of normal intelligence with pervasive developmental disorders: Prevalence, severity, and pattern. Journal of the American Academy of Child and Adolescent Psychiatry, 44, 815–822.PubMedCrossRefGoogle Scholar
- Dunn, L. M. (1997). Peabody picture vocabulary test (3rd ed.). Minneapolis, MN: American Guidance Service.Google Scholar
- Goldman S. E., Richdale A. L., Clemons T., & Malow B. A. (2011b). Sleep behaviors in autism spectrum disorders—variations in age from early childhood through adolescence. Journal of Autism and Developmental Disorders, May 3 (epub ahead of print).Google Scholar
- Harrington, J. W., Rosen, L., & Garnecho, A. (2006). Parental perceptions and use of complementary and alternative medicine practices for children with autism spectrum disorders in private practice. Journal of Developmental and Behavioral Pediatrics, 27(2 Suppl), S156–S161.PubMedCrossRefGoogle Scholar
- Hollingshead, A. B. (1975). Four factor index of social status. New Haven, CT: Yale University, Department of Sociology.Google Scholar
- Hollway, J. A., & Aman, M. G. (2011). Sleep correlates of pervasive developmental disorders: A review of the literature. Research in Developmental Disabilities. doi: 10.1016/j.ridd.2011.04.001.
- Kaufman, A. S., & Kaufman, N. L. (2004). Kaufman brief intelligence test (2nd ed.). Circle Press, MN: American Guidance Service, Inc.Google Scholar
- Lord, C., Risi, S., Lambrecht, L., Cook, E. H., Jr, Leventhal, B. L., DiLavore, P. C., et al. (2000). The autism diagnostic observation schedule-generic: A standard measure of social and communication deficits associated with the spectrum of autism. Journal of Autism Developmental Disorders, 30(3), 205–223.CrossRefGoogle Scholar
- Phillips Respironics. Actiware/Actiware-ct (2010). Actiwatch communication and sleep analysis software instruction manual. Software Version 5.9.Google Scholar
- Westfall, P., Tobias, R. D., Ron, D., Wolfinger, R. D., & Hochberg, Y. (1999). Multiple comparisons and multiple tests using SAS. Cary, NC: SAS Institute Inc.Google Scholar