A randomized-controlled trial of the effects of a traditional herbal supplement on sleep onset insomnia

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.