Melatonin Helpful for Delayed Sleep Onset in Children With ADHD

Laurie Barclay, MD

October 21, 2003

Oct. 21, 2003 — Melatonin may be helpful for treating delayed sleep onset in children with attention deficit-hyperactivity disorder (ADHD), according to the results of a double-blind, crossover-design pilot study presented at the American Academy of Child and Adolescent Psychiatry annual meeting held in Miami, Florida.

"Dosing at 6 mg in this study may be perceived by many clinicians as high," coauthor Melissa Bomben, MSc, a project manager of the Mental Health Research Unit at the University of British Columbia in Vancouver, told Medscape. "However, clinical practice at British Columbia's Children's Hospital has yielded a 20-year history of adequate doses for children in the 2.5-mg to 10-mg range. Doses in excess of 10 mg are not uncommon."

In the nine children (seven boys and two girls) enrolled in this trial, mean age was 10 years (range, 7-13 years), mean baseline sleep onset latency was 99 minutes, and mean Clinical Global Impression (CGI) score at baseline was 5.5, reflecting marked to severe difficulty in functioning.

Based on sleep logs completed by parents, sleep onset delay was improved during melatonin treatment for each night of the week. Statistical tests for order and treatment-by-order (carryover) effects were not significant. Mean sleep onset latency was 51 minutes during melatonin treatment and 88 minutes during the placebo phase ( P = .04). There were no significant adverse events and no reported differences between groups in CGI-improvement ratings.

"The side effect profile of melatonin is relatively benign. Long-term side effects of melatonin have not been prospectively studied," Ms. Bomben said. "Confirmation of the continuity of response was found in observations from a three-month maintenance period."

Although parents were encouraged to establish consistent bed and waking times, it was not required to continue in the trial. Patients whose sleep hygiene was not consistent from day to day had less improvement with melatonin treatment. The greatest reductions in sleep onset latency occurred in patients with the largest placebo phase latencies, suggesting that the relative improvement with melatonin might have been attenuated by smaller sleep onset latencies.

Although this study did not screen patients based on stimulant medication use and type, the investigators are currently conducting a larger trial involving only children with ADHD who are taking stimulant medications and who have daily sleep onset latency problems. This trial has the added features of strict adherence to sleep hygiene, actigraphy as an objective measure of sleep, and ADHD rating scales to monitor potential changes in symptomatology. Results of this trial are anticipated in the summer of 2004.

"Since melatonin is in an unusual category, being an unpatentable hormone considered in the U.S. to be a 'nutritional supplement' that is unregulated by the [Food and Drug Administration], and since there is evidence that some brands contain other than 'pharmaceutically pure' melatonin, evidence of safety and efficacy is of great importance to clinicians," Ms. Bomben said.

The Centre for Complementary Medicine, a Vancouver-based nonprofit association that is no longer operating, supported this study. The authors report no financial disclosures relevant to the research presented in this poster, but they are now engaged in an industry-funded contract for new studies of melatonin.

AACAP 50th Annual Meeting: Abstract E16. Presented Oct. 14-19, 2003.

Reviewed by Gary D. Vogin, MD

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