Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study
Eight-week parallel-group RCT (n=80; 40 healthy and 40 insomnia) found ashwagandha root extract improved polysomnography and questionnaire sleep metrics versus placebo, with larger signals in the insomnia stratum (including sleep onset latency, sleep efficiency, PSQI, and anxiety scale changes).
Design
Double-blind, parallel-group RCT; 80 participants stratified into Arm A healthy (n = 40) and Arm B insomnia (n = 40); 8 weeks; outcomes included SOL, TST, WASO, TIB, sleep efficiency, PSQI, HAM-A, mental alertness, and sleep-quality questionnaire; safety monitoring for AEs and concomitant meds.
Results (abstract highlights)
- Within insomnia arm: repeated-measures ANOVA reported SOL (p = 0.013), HAM-A (p < 0.05), mental alertness (p = 0.01), and sleep quality (p < 0.05) improvements favouring ashwagandha
- Two-way ANOVA: SOL and sleep efficiency most improved (p < 0.0001), followed by TST (p < 0.002) and WASO (p = 0.040) in insomnia participants
- Tolerability: authors report well tolerated across health strata
Evidence hygiene
Single multi-centre RCT—complement with Akhgarjand 2022 anxiety meta and other sleep-objective trials on sleep-optimization before overgeneralising to severe insomnia or OSA.
Publication
Langade D, Kanchi S, Salve J, et al. J Ethnopharmacol. 2021 Jan 10;264:113360. PMID 32818573.
Outcomes
- 8-week RCT (n=80): ashwagandha vs placebo improved sleep onset latency and sleep efficiency most strongly in insomnia stratum (two-way ANOVA p < 0.0001 for SOL and efficiency).
- Insomnia arm also showed significant PSQI, sleep-quality questionnaire, and HAM-A improvements vs placebo (p-values in abstract); product well tolerated across groups.