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Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study
Sejal V Jain1, Paul S Horn2, Narong Simakajornboon3
1Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Insights
This study found that sustained release melatonin significantly improved sleep onset and reduced wakefulness in children with epilepsy. However, the study was too small to determine melatonin
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Epileptology
Background:
- Insomnia is a common issue in children with epilepsy, impacting quality of life.
- Melatonin is frequently used for sleep disturbances, but its efficacy in pediatric epilepsy is not well-established.
- Maintenance insomnia presents a significant challenge in managing epilepsy in pediatric populations.
Purpose of the Study:
- To evaluate the efficacy of sustained release melatonin in improving sleep parameters in children with epilepsy.
- To assess the impact of melatonin on seizure control and epileptiform activity in pediatric epilepsy.
- To investigate the effects of melatonin on cognitive function, specifically reaction time, in this population.
Main Methods:
- A randomized, double-blind, placebo-controlled, crossover study involving 11 children (aged 6-11 years) with epilepsy.
- Participants received either 9-mg sustained release melatonin or placebo for four weeks, followed by a crossover period.
- Primary outcomes included polysomnography-measured sleep onset latency and wakefulness after sleep onset (WASO); secondary outcomes included seizure frequency and EEG spike density.
Main Results:
- Melatonin significantly decreased sleep onset latency (11.4 min reduction) and WASO (22 min reduction) compared to placebo.
- No significant worsening in seizure frequency or epileptiform spike density was observed with melatonin use.
- Statistically significant changes in sleep architecture were noted, including increased slow-wave sleep duration and REM latency, and decreased REM sleep duration.
Conclusions:
- Sustained release melatonin effectively improves sleep latency and wakefulness in children with epilepsy.
- The study suggests melatonin does not exacerbate seizures, but larger trials are needed to confirm this.
- Further research is warranted to explore the full spectrum of melatonin's effects on sleep and epilepsy in children.
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.
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