Melatonin Helps Epileptic Children Sleep
Sejal V Jain, MD, Paul S Horn, PhD; Narong Simakajornboon, MD; Dean W Beebe,PhD; Katherine Holland, MD, PhD; Anna W Byars, PhD; Tracy A Glauser, MD; Melatonin improves sleep in children with epilepsy: randomized, double-blind cross-over study.
In Sleep Medicine: http://www.sciencedirect.com/science/article/pii/S1389945715000477
Insomnia, especially maintenance insomnia is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. In this study, a randomized, double-blind, placebo-controlled, cross-over study was performed to identify the effects of melatonin on sleep and seizure control in children with epilepsy.
Eleven pre-pubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by software algorithm to receive placebo or 9 mg sustained release melatonin for 4 weeks, followed by a 1-week washout and 4-week crossover condition. The pharmacy performed blinding; patients, parents and study staff other than a statistician were blinded. Primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. Secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on EEG and reaction time measures on psychomotor vigilance task. Statistical tests appropriate for cross-over designs were used for analysis.
Data were analyzed from ten subjects who completed the study. Melatonin decreased sleep latency (Mean difference (MD): 11.4 min, p= 0.02) and WASO (MD 22 min, p=0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, Slow-wave sleep duration and 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.
Sustained-release 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.
The data presented in this study support the efficacy of melatonin in treating objective insomnia associated with epilepsy in children. Data regarding the effects of melatonin on seizures were inconclusive due to the small number of subjects in the study.