This was a double-blind, placebo-controlled, crossover study of subjects with insomnia and epilepsy. Each subject was treated with pregabalin 150 mg BID or placebo for two weeks, followed by a two-week washout period, then the other treatment for two weeks. Polysomnography and neuropsychological testing were performed at baseline and at the end of each treatment arm.
There was a significant increase in percentage of slow-wave sleep and a decrease in stage 1 sleep when subjects were taking pregabalin. Sleep efficiency increased during pregabalin treatment, although this was not statistically significant (84.5 +/鈭?#xA0;4.6%for placebo versus 90.4 +/鈭?#xA0;2.6%for pregabalin). There were a significant improvement in attention in the pregabalin group based on trial one of the Rey-Auditory Verbal Learning Test and a trend toward improvement in the psychomotor vigilance task; other neuropsychological measures were not significantly changed.
Concurrent treatment with pregabalin improves sleep depth in patients with insomnia and epilepsy and improves daytime attention.