Carl W Bazil1, Julianne Battista, Robert C Basner. 1. Department of Neurology, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA. cwb11@columbia.edu
Abstract
BACKGROUND:Epilepsy patients commonly suffer from sleep disturbances, and these can exacerbate memory dysfunction and seizures. Sleep can be affected by seizures, independent sleep disorders, or anticonvulsant drugs. Levetiracetam is a novel anticonvulsant effective for the treatment of partial seizures. We studied the effects of levetiracetam (LEV) on sleep using polysomnography in normal subjects. METHODS: Subjects (aged 18-40) were screened for freedom from sleep disorders, excessive daytime sleepiness, and depression. Screening overnight polysomnography was performed, followed by baseline polysomnography. Subjects were randomized to placebo or LEV, titrated to 1000 mg twice daily over 9 days. Polysomnography was repeated on Treatment Day 28. Differences between baseline and treatment in the drug and placebo groups were compared using single-factor ANOVA. RESULTS:Seventeen subjects were enrolled; 14 completed the study (8 placebo, 6 LEV). All subjects who remained on LEV were able to tolerate the target dose. There were no significant differences between the placebo and drug groups with respect to baseline sleep characteristics. When baseline polysomnography was compared with treatment polysomnography, there were no differences in the change in sleep efficiency, sleep latency, total sleep time, REM latency, or percentages of REM, stage 1, stage 2, or slow wave sleep. There was an increase in the number of awakenings in the drug group that was significant compared with placebo. CONCLUSION: These results suggest that LEV does not have major effects on sleep structure.
RCT Entities:
BACKGROUND:Epilepsypatients commonly suffer from sleep disturbances, and these can exacerbate memory dysfunction and seizures. Sleep can be affected by seizures, independent sleep disorders, or anticonvulsant drugs. Levetiracetam is a novel anticonvulsant effective for the treatment of partial seizures. We studied the effects of levetiracetam (LEV) on sleep using polysomnography in normal subjects. METHODS: Subjects (aged 18-40) were screened for freedom from sleep disorders, excessive daytime sleepiness, and depression. Screening overnight polysomnography was performed, followed by baseline polysomnography. Subjects were randomized to placebo or LEV, titrated to 1000 mg twice daily over 9 days. Polysomnography was repeated on Treatment Day 28. Differences between baseline and treatment in the drug and placebo groups were compared using single-factor ANOVA. RESULTS: Seventeen subjects were enrolled; 14 completed the study (8 placebo, 6 LEV). All subjects who remained on LEV were able to tolerate the target dose. There were no significant differences between the placebo and drug groups with respect to baseline sleep characteristics. When baseline polysomnography was compared with treatment polysomnography, there were no differences in the change in sleep efficiency, sleep latency, total sleep time, REM latency, or percentages of REM, stage 1, stage 2, or slow wave sleep. There was an increase in the number of awakenings in the drug group that was significant compared with placebo. CONCLUSION: These results suggest that LEV does not have major effects on sleep structure.