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.