The prevalence of epilepsy is 1% in the USA. About 30% of epilepsy patients eventually become
refractory to medical treatment. Co morbid conditions are becoming as important as seizure
control as these affect overall wellbeing. Sleep related complaints are frequent in them
including, frequent arousals, difficulty falling asleep and excessive daytime sleepiness.
Polysomnography shows increased arousal index, sleep onset latency, and stage shifts and
fragmented REM sleep. Poor sleep efficiency causes daytime fatigue, poor cognition and
behavior and can worsen seizure control. Stabilizing sleep may improve seizure control.
Melatonin is a naturally occurring hormone in the body involved in the regulation of
circadian rhythm and exogenously given, has been shown to decrease sleep onset latency,
arousals, and there-by increase sleep efficiency in healthy pediatric patients. Similar data
does not exist in the patients with epilepsy. As sleep has important impact on epilepsy and
overall functioning, it is important to study effect of melatonin in children with epilepsy.
We propose a randomized double blind placebo controlled trial with a cross-over design. Our
hypothesis is that, for patients with epilepsy, administration of melatonin 30 minutes before
bedtime for four weeks may:
- Improve the quality of sleep;
- Improve daytime functioning in terms of cognition, behavior and quality of life;
- Decrease epileptic potential. We will use polysomnography, electroencephalogram,
psychomotor vigilance task, seizure diary, and questionnaires to assess the effect of
melatonin on these domains. This study may help to improve the care of children with
epilepsy.