title: Long-term effectiveness outcome of melatonin therapy in children with treatment-resistant circadian rhythm sleep disorders.
abstract: To date, there have been no prospective long-term studies of melatonin therapy in children. We report here data from a prospective follow-up study of 44 children with neurodevelopmental disabilities and treatment-resistant circadian rhythm sleep disorders (CRSD) who had participated in a placebo controlled, double blind cross-over trial of sustained-release melatonin. The follow-up study involved a structured telephone interview of caregivers every 3 months for upto 3.8 yr. The caregivers provided ratings of satisfaction, adverse effects, benefits, persistence with treatment and additional medications. Changes in melatonin dose were recorded. Open ended questions were included to capture caregivers' impressions and comments concerning melatonin therapy. Adverse reaction to melatonin therapy and development of tolerance were not evident. Better sleep was associated with reported improvement in health, behavior and learning. At the end of the study, the parental comments regarding the effectiveness of long-term melatonin therapy were highly positive. Parents whose children had sleep maintenance difficulties expressed a wish to have a commercially available controlled-release melatonin product which would promote sleep for 8-10 hr. Hypnotics for children with CRSD should be considered a second line of treatment for those who fail to respond to sleep hygiene and/or melatonin.
authors.affiliation: Melatonin Research Group, Department of Psychiatry, BC Children's Hospital, Vancouver, BC, Canada.
authors.forename: Roxanne
authors.initials: R
authors.lastname: Carr
authors.forename: Michael B
authors.initials: MB
authors.lastname: Wasdell
authors.forename: Donald
authors.initials: D
authors.lastname: Hamilton
authors.forename: Margaret D
authors.initials: MD
authors.lastname: Weiss
authors.forename: Roger D
authors.initials: RD
authors.lastname: Freeman
authors.forename: Joseph
authors.initials: J
authors.lastname: Tai
authors.forename: Wop J
authors.initials: WJ
authors.lastname: Rietveld
authors.forename: James E
authors.initials: JE
authors.lastname: Jan
mesh_terms: D002492:Central Nervous System Depressants / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008550:Melatonin / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D020178:Sleep Disorders, Circadian Rhythm / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002492:Central Nervous System Depressants; D003692:Delayed-Action Preparations; D008550:Melatonin