Effects of pregabalin in patients with hypnotic-dependent insomnia

Long-term use of hypnotics runs the risk of dependency, and subjects usually experience difficulties in withdrawal. The objective of this study was to investigate the success of withdrawal using pregabalin and its efficacy on sleep in patients with hypnotic-dependent insomnia.

We enrolled patients with hypnotic-dependent insomnia who were 18 years or older. The starting dosage of pregabalin was 75 mg/day and was increased up to as much as 300 mg/day, depending on the individual patient's condition, while tapering off hypnotics. After 4 weeks of titration, the final dosage amount was maintained for at least another 4 weeks. Sleep and clinical variables were evaluated at baseline and after treatment, using the Korean versions of various sleep questionnaires as well as polysomnography.

Forty subjects were enrolled, with a mean age of 52.0 ± 8.5 years, of whom 28 (70.0%) were women. Twenty-one (52.5%) subjects successfully withdrew from hypnotics. The duration of withdrawal was 42.1 ± 16.0 days (range: 27.0∼84.0). The mean pregabalin dose was 121.4 ± 69.0 mg/day (range: 75.0∼300.0). After pregabalin treatment, there was a significant improvement in the total score of the Pittsburgh Sleep Quality Index (15.0 ± 2.1, 8.9 ± 3.0, p < 0.001), and insomnia severity index (20.9 ± 4.3, 9.6 ± 4.4, p < 0.001); however, most of the sleep variables of the PSG showed no differences. The main adverse effects of pregabalin were nausea and dizziness.

Our results showed pregabalin may be a promising candidate for withdrawal from hypnotics and improved sleep in patients with hypnotic-dependent insomnia.