Journal
SLEEP MEDICINE
Volume 16, Issue 5, Pages 637-644Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.sleep.2015.01.005
Keywords
Seizure frequency; Sleep latency; WASO; Sleep architecture; Natural supplement; EEG spikes
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Funding
- National Center for Research Resources
- National Center for Advancing Translational Sciences, National Institutes of Health [8 UL1 TR000077]
- Clinical Research Feasibility Funds (CReFF) by the Center for Clinical and Translational Science, and Training, Cincinnati Children's Hospital Medical Center
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Objective: Insomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Methods: Eleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis. Results: Data were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. Conclusion: SR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard. (C) 2015 Elsevier B.V. All rights reserved.
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