Comparative Evaluation of Ashwagandha (Withania somnifera) Root Extract and Melatonin for Improving Sleep Quality in Adults: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Ashwagandha, a revered herb in Ayurvedic medicine for over 3000 years, is recognized for its potential benefits in regulating sleep and supporting overall vitality. This study evaluated the comparative effects of Ashwagandha root extract (ARE) and melatonin (MLT) on sleep quality in adults. In this prospective, randomized, double-blind, placebo-controlled trial, 200 men and women aged 18–50 years were randomized to receive ARE (300 mg twice daily; n = 50), MLT (3 mg/day; n = 50), a combination of ARE (600 mg/day) and MLT (3 mg/day; n = 50), or placebo (n = 50) for eight weeks. The primary outcome was the change in sleep onset latency (SOL) from baseline to week eight, measured by actigraphy. Secondary outcomes included actigraphy-based changes in total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE), as well as subjective measures such as the Pittsburgh Sleep Quality Index (PSQI) and the Hamilton Anxiety Scale (HAM-A). At week eight, SOL was significantly reduced across treatment groups, with the ARE–MLT (p < 0.0001) combination showing the greatest improvement. The combination group also demonstrated significant improvements in TST (p < 0.0001), WASO (p < 0.0001), and SE (p < 0.0001), whereas ARE and MLT monotherapy produced moderate but comparable benefits. Inferential analyses confirmed statistically significant improvements in objective and subjective sleep measures (p < 0.0001). Safety analyses indicated that mild adverse events occurred across all groups, with no clinically significant between-group differences. Overall, both Ashwagandha and melatonin improved sleep disturbances in adults, with combination therapy producing the most consistent and pronounced benefits.