A randomized clinical trial of valerian fails to improve self-reported, polysomnographic, and actigraphic sleep in older women with insomnia.

OBJECTIVE: To test the effects of nightly valerian (Valeriana officinalis) extract to improve sleep of older women with insomnia. METHODS: Participants in this phase 2 randomized, double-blind, crossover controlled trial were 16 older women (mean age=69.4+/-8.1 years) with insomnia. Participants took 300 mg of concentrated valerian extract or placebo 30 min before bedtime for 2 weeks. Sleep was assessed in the laboratory by self-report and polysomnography (PSG) at baseline and again at the beginning and end of each treatment phase (total of nine nights in the laboratory) and at home by daily sleep logs and actigraphy. RESULTS: There were no statistically significant differences between valerian and placebo after a single dose or after 2 weeks of nightly dosing on any measure of sleep latency, wake after sleep onset (WASO), sleep efficiency, and self-rated sleep quality. In comparing each treatment to baseline in separate comparisons, WASO significantly increased (+17.7+/-25.6 min, p=.02) after 2 weeks of nightly valerian, but not after placebo (+6.8+/-26.4 min, NS). Side effects were minor and did not differ significantly between valerian and placebo. CONCLUSION: Valerian did not improve sleep in this sample of older women with insomnia. Findings from this study add to the scientific evidence that does not support use of valerian in the clinical management of insomnia.