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Add-on melatonin improves sleep behavior in children with epilepsy: randomized, double-blind, placebo-controlled
Madhur Gupta1, Satinder Aneja, Kamlesh Kohli
1Department of Pharmacology, Lady Hardinge Medical College and Associated Hospitals, New Delhi, India. madhurgupta@hotmail.com
Insights
Add-on melatonin significantly improved sleep behavior and reduced parasomnias in epileptic children on sodium valproate. This study suggests melatonin as a promising treatment for sleep issues in pediatric epilepsy.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Pharmacology
Background:
- Sleep disturbances are common in children with epilepsy.
- Sodium valproate monotherapy can be associated with sleep problems.
- Effective management of sleep issues is crucial for overall well-being in epileptic children.
Purpose of the Study:
- To evaluate the efficacy of add-on melatonin in improving sleep behavior in epileptic children aged 3-12 years on sodium valproate monotherapy.
- To assess the impact of melatonin on total sleep, parasomnias, daytime drowsiness, and sleep fragmentation.
Main Methods:
- Double-blind, randomized, placebo-controlled study involving 31 epileptic children.
- Participants received either add-on melatonin or placebo alongside sodium valproate.
- Parental questionnaires were used to assess sleep behavior and related parameters.
Main Results:
- A statistically significant greater percentage decrease in median total sleep scores was observed in the melatonin group (24.4%) compared to the placebo group (14.0%).
- The melatonin group showed a significantly greater median percentage decrease in parasomnias scores (60%) versus the placebo group (36.4%).
- No significant differences were found in daytime drowsiness or sleep fragmentation scores between the groups.
Conclusions:
- Add-on melatonin demonstrates significant efficacy in improving overall sleep and reducing parasomnias in epileptic children treated with sodium valproate.
- Melatonin presents a promising and safe therapeutic option for managing sleep disturbances in pediatric epilepsy.
- Further research may explore long-term effects and optimal dosing of melatonin in this population.
Abstract:
This double-blind, randomized, placebo-controlled study in epileptic children, aged 3 to 12 years, evaluated the effect of add-on melatonin on the sleep behavior of these children on sodium valproate monotherapy using a parental questionnaire. Of the 31 patients, 16 randomly received add-on melatonin, whereas 15 received add-on placebo. The questionnaire showed good internal consistency in our patient population (Cronbach's alpha = .83). The percentage decrease in the median total sleep score was 24.4 (range 0.0-34.9) in the valproate + melatonin group compared with 14.0 (range -2.2-18.8) in the valproate + placebo group, the difference being statistically significant (P < .05). The median percentage decrease in the parasomnias score was 60 (range 0.0-70.8) in the valproate + melatonin group compared with 36.4 (range 0.0-63.2) in the valproate + placebo group, the difference being statistically significant (P < .05). There was no significant difference between the percentage decrease in the daytime drowsiness scores and sleep fragmentation scores. Parent-child interaction subscale scores were not significantly different between age groups. The age at onset of seizures and the type of seizures did not correlate significantly to the total sleep scores. Given that sleep problems are known to complicate epilepsy, add-on melatonin, which has a wide safety window, can be of promise in the pharmacotherapy of pediatric epilepsy.
