N H Farag1, P J Mills. 1. Department of Psychiatry, University of California at San Diego, 9500 Gilman Drive, Dept. 0804, La Jolla, CA 92093-0804, USA. nfarag@ucsd.edu
Abstract
OBJECTIVES: To study the effectiveness and safety of a traditional herbal supplement used for sleep onset insomnia. DESIGN: A double-blind, randomized, placebo-controlled, cross-over study. SETTING: A total of 25 healthy volunteers (20-65 years of age) suffering from sleeponset insomnia were recruited from the general population. INTERVENTION: A traditional Ayurvedic supplement formulated to reduce sleep onset insomnia. MAIN OUTCOME MEASURE: Sleep latency. RESULTS: The supplement led to a statistically significant decrease in reported sleep latency of 16.72 min (S.D.=44.8) as compared to placebo (P=0.003). There were no self-reported side effects. CONCLUSIONS: The findings suggest that traditional herbal supplements may be of significant benefit to patients suffering from sleep onset insomnia while avoiding the negative side effects of commonly prescribed hypnotics.
RCT Entities:
OBJECTIVES: To study the effectiveness and safety of a traditional herbal supplement used for sleep onset insomnia. DESIGN: A double-blind, randomized, placebo-controlled, cross-over study. SETTING: A total of 25 healthy volunteers (20-65 years of age) suffering from sleep onset insomnia were recruited from the general population. INTERVENTION: A traditional Ayurvedic supplement formulated to reduce sleep onset insomnia. MAIN OUTCOME MEASURE: Sleep latency. RESULTS: The supplement led to a statistically significant decrease in reported sleep latency of 16.72 min (S.D.=44.8) as compared to placebo (P=0.003). There were no self-reported side effects. CONCLUSIONS: The findings suggest that traditional herbal supplements may be of significant benefit to patients suffering from sleep onset insomnia while avoiding the negative side effects of commonly prescribed hypnotics.