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.
Füssel
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Zeller AG, Seeblickstr. 4, CH-8590 Romanshorn, Switzerland. axel. brattstroem@zellerag.ch
Wolf
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Brattström
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D000284:Administration, Oral; D006801:Humans; D027582:Humulus; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000627:therapeutic use; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage* / Q000494:pharmacology* / Q000627:therapeutic use; D010946:Plants, Medicinal; D017286:Polysomnography; D012890:Sleep / Q000187:drug effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D014632:Valerian
C039603:Hova; D006993:Hypnotics and Sedatives; D010936:Plant Extracts