Effect of a fixed valerian-Hop extract combination (Ze 91019) on sleep polygraphy in patients with non-organic insomnia: a pilot study.

A pilot study with a fixed extract combination Ze 91019 of valerian and hop was conducted in 30 patients suffering from mild-moderate, non-organic insomnia. The diagnosis was confirmed by polysomnographic standard examinations. The patients were treated with 2 tablets in the evening. Each tablet contains 250 mg valerian extract and 60 mg hop extract. A polysomnographic re-examination after 2 weeks of treatment revealed declines in the sleep latency and the wake time. As a consequence the sleep efficiency increased. Sleep stage 1 (S1) was reduced and the slow wave sleep increased. In addition, the patients judged their being refreshed in the morning by assigning a rating of 1 to 6. They reported an improvement after 2 weeks of treatment. No adverse events were observed. Based on these findings a pivotal study can be designed.