Supplements · Reference article
Ashwagandha for stress, sleep and anxiety: what trials show
Ashwagandha trials, meta-analyses, liver injury reports and European regulator warnings checked against a 'cope supplement' tier list, with a verdict.
Published · Updated · Rests on: 5 meta-analyses, 3 RCTs, 1 safety cohort, 2 liver case reports/series, 5 regulator documents (BfR, ANSES, RIVM, Danish FVST, UK FSA), NCCIH page
This is a reference article, not a price comparison. Peptilyze compares prices of research peptides; it sells nothing and gives no medical advice. Every claim is numbered and listed under Sources.
Key points
- Several meta-analyses of small randomized trials report lower stress and anxiety scores and better sleep scores than placebo, but the reviewers rated the certainty of the evidence as low for stress and anxiety [1][2].
- Most trials last 8-10 weeks and enrol 60 people or fewer. Many used one of a few branded root extracts, and the reviews report heterogeneity from moderate to extreme [1][2][5].
- How ashwagandha might work in humans is not established. A stress-hormone (cortisol) effect is reported in some trials, and regulators say the active compounds cannot be pinned down [8][13][15].
- Liver injury is documented in case reports and a case series, and several European regulators advise against supplements in certain groups. Denmark does not allow it to be sold as food [11][13][15][16].
- The “extremely cope” label on a social-media tier list is only partly supported: the benefit is modest and uncertain, not absent.
What ashwagandha is
Ashwagandha is the root, and sometimes the leaf, of Withania somnifera, used in Ayurvedic medicine and sold today as a capsule, powder or tea. The main constituents are steroid-like withanolides and alkaloids. Their content varies widely between plant parts and extraction methods, and some products have been found adulterated with leaf material [13][15]. That matters for evidence: results for one branded extract cannot be assumed to apply to another.
What the randomized trials and reviews found
The evidence is a set of small trials, most from India, pooled by reviews of uneven quality. All results below are human randomized trials against placebo unless noted.
| Review (year) | Trials / people | Main result | Reviewers’ quality notes |
|---|---|---|---|
| Akhgarjand, Phytother Res (2022) [1] | 12 / 1,002 adults, aged 25-48 | Anxiety SMD -1.55, stress SMD -1.75 | Heterogeneity I² 94% and 83%; certainty of evidence low for both |
| Cheah, PLoS One (2021), sleep [2] | 5 / 400 | Sleep SMD -0.59 | Review unfunded, no competing interests. Risk of bias low or unclear in most domains; one trial unclear on blinding. Certainty “moderate” overall, low for some outcomes; too few trials for a funnel plot |
| Arumugam, Explore (2024) [3] | 9 / 558 | Perceived Stress Scale -4.72 points, Hamilton Anxiety -2.19, cortisol -2.58 | Four trials reported mild to moderate adverse events; abstract gives no bias rating |
| Fatima, Hum Psychopharmacol (2024) [4] | 5 / 254 | Hamilton Anxiety -5.96 points; better sleep latency, total sleep time, sleep efficiency | I² 98%; Cochrane risk-of-bias tool used, domain results not seen by us |
| Marchi, BJPsych Open (2025) [5] | 14 / 360 treated, 353 controls, people with mental disorders (mostly anxiety) | Anxiety, stress, depression and sleep scores improved; effect shrank after outlier correction (anxiety -1.96 to -1.13) | Median follow-up 8 weeks; authors cite small number of studies, heterogeneity and outliers |
Three points stand out. First, effect sizes of 1.5 standard deviations with I² above 80% are unusually large for a supplement, and the authors themselves rated the certainty low [1]. Second, a 2026 review of 49 controlled reports on Ayurvedic herbs, with ashwagandha the best-studied for stress and sleep, cited “small-study effects” and reporting quality as limits [6]. Third, the sleep review found that four of five trials used the root extract KSM-66 (250 participants) and one used Shoden, a root-and-leaf extract (150 participants); one trial was partly sponsored by a manufacturer, and funding for the other four was not stated [2]. We could not open the full text of the other reviews, so their bias ratings and funder tables are not reported here.
Three individual trials show the typical design:
- Chandrasekhar 2012 (India): 64 adults with chronic stress, a full-spectrum root extract against placebo for 60 days. Stress scores and serum cortisol fell more with ashwagandha; adverse events were mild and similar in both groups. Authors declared no conflict of interest; the funder is not in the abstract [7].
- Lopresti 2019 (India): 60 stressed adults, 60 days, a root extract (Shoden). The Hamilton Anxiety score fell more than with placebo (P = 0.040), the DASS-21 change was not significant (P = 0.096), and morning cortisol and DHEA-S fell more. The first author disclosed past funding from an ashwagandha extract maker for unrelated studies [8].
- Langade 2019 (India): 60 people with insomnia and anxiety randomized, 58 analysed, 10 weeks. Sleep-onset latency was shorter than with placebo (P = 0.019) and sleep quality scored better (P = 0.002). Funding is not stated in the abstract [9].
Outcomes were mostly questionnaires, taken in short trials. We found no large, long, independently funded trial in the sources we opened. A prospective 12-month observational study of 191 adults reported no meaningful change in liver enzymes, but it had no control group [10].
What is known about mechanism
Not much, in people. The Lopresti trial proposed an effect on the hypothalamic-pituitary-adrenal (stress hormone) axis because cortisol fell [8], and the 2024 meta-analysis pooled a cortisol reduction [3]. A cortisol change shows an association in a trial, not how the extract acts. France’s agency ANSES notes that in-vitro work suggests GABA-related activity, and that studies rarely state the composition of the extracts tested, so compounds cannot be linked to effects [15]. Germany’s BfR says it is not possible to identify which substances or amounts produce the reported effects [13].
Liver injury
The 2020 Iceland and US case series described five patients who developed jaundice 2-12 weeks after starting ashwagandha supplements. The pattern was cholestatic or mixed, liver tests normalized in four patients within 1-5 months, one was lost to follow-up, and no patient had liver failure. Four were also taking other supplements, and in one case rhodiola was a possible co-cause [11]. A 2023 review of published cases added two new patients and noted that one reported case ended in liver transplantation [12]. The NIH LiverTox entry would be the standard reference for causality grading; we could not open it, because the site blocked our request, so we do not quote its rating.
ANSES had received 8 French adverse-effect reports through September 2023 and analysed 6; its table includes an acute hepatitis in a 68-year-old woman who was also taking other products and an occasional benzodiazepine [15]. Case reports cannot give a rate. No source we opened estimated how often liver injury occurs.
Regulatory status
- United States (NIH page, March 2023): ashwagandha is sold as a dietary supplement, which the FDA does not approve before sale. The NIH’s NCCIH page (March 2023) says rare liver injury cases are linked to it, advises avoiding it in pregnancy and while breastfeeding, and says people with autoimmune or thyroid disorders should not use it [21]. We did not find an FDA statement specific to ashwagandha.
- Denmark: the food agency states that selling products containing ashwagandha is illegal, citing a DTU risk assessment of effects on sex hormones, thyroid, immune system and central nervous system. The page has no date; trade press places the ban in 2023 [16][17].
- Germany: BfR communication 39/2024 (10 September 2024) says the claimed benefits are not scientifically proven, and that children, pregnant and breastfeeding women and people with acute or pre-existing liver disease should not take ashwagandha supplements. It cites interactions with antidiabetic, blood-pressure and immunosuppressant drugs, and says no health-based safe intake could be derived [13].
- Netherlands: RIVM report 2024-0029 (5 March 2024) advises, as a precaution, against herbal preparations containing it, especially in pregnancy, citing traditional abortifacient use that has not been studied [14].
- France: ANSES opinion 2021-SA-0077 (19 April 2024) advises people with thyroid, liver or heart conditions, hyperandrogenism, pregnant women and people on sedatives or CNS depressants to abstain. It adds breastfeeding women and under-18s as a precaution [15].
- Australia: a March 2024 TGA advisory, as summarized by Medicine Today (we could not open the TGA page), says that in very rare cases these products may cause liver injury [20].
- United Kingdom: the Food Standards Agency ran a call for evidence from 8 July to 1 September 2024 and published a summary of 19 responses on 25 June 2026. A risk assessment by its Committee on Toxicity is pending; the page gives no safe level [19].
- EU level: trade press reports European regulators are considering an Article 8 review, discussed at a European Parliament meeting on 14 July 2026, and that it has not been opened. We found no EFSA or Commission document and cannot confirm this [17][18]. We did not check the EMA or UK medicines registers; “research use only” does not apply to ashwagandha.
Risks and unknowns
- Documented effects: nausea, vomiting, diarrhoea, drowsiness, headache, dizziness and rashes are listed by BfR; liver injury is the effect regulators single out [13][15].
- Populations at risk: pregnancy (traditional abortifacient use, not studied), breastfeeding, children, thyroid disease, liver or heart disease, and hyperandrogenism, as named by BfR, ANSES, RIVM and NCCIH [13][14][15][21].
- Interactions: BfR names antidiabetic, antihypertensive and immunosuppressant drugs. ANSES advises against combining with sedatives and CNS depressants and says interaction data are heterogeneous. NCCIH says thyroid hormone medicines may interact [13][15][21].
- Not studied: long-term use in controlled trials, safety in pregnancy, dose-dependence of liver injury, whether root-only extracts carry lower risk than whole-plant products, and head-to-head comparisons with established treatments for anxiety or insomnia. Most trials did not systematically record adverse events, per BfR [13].
What the source post claims
On 15 October 2026, @Hoostethics posted “ranking the most cope supplements.” with a tier-list image [22]. In the image, a bottle labelled ashwagandha root extract sits in the top row, “EXTREMELY COPE”, next to cannabis, phenibut, finasteride, an SSRI and diazepam. The post gives no reasoning. Its other tiers are covered in our check of the full list.
Verdict: partly supported. “Cope” in the sense of a modest effect with low-certainty evidence fits what the reviews say. Placing ashwagandha in the extreme tier overstates the case: independent reviews point the same direction on stress, anxiety and sleep scores. But the trials are short, small, and often rely on a few branded extracts, and the same evidence cannot establish clinical importance. The tier list also leaves out the liver and pregnancy cautions, and it mixes products with very different evidence.
Frequently asked questions
Does ashwagandha reduce stress and anxiety? In pooled randomized trials it lowered stress and anxiety scores more than placebo. The reviewers rated certainty as low and the trials were small and short [1][3].
Does ashwagandha help sleep? A review of 5 trials (400 people) found a small improvement on sleep measures, with more benefit in people diagnosed with insomnia. Reviewers noted limited safety data [2].
Why is ashwagandha banned in Denmark? Denmark’s food agency cites a DTU risk assessment that found possible effects on sex hormones, thyroid, immune system and nervous system. The agency says that is why sale is illegal [16].
Who do regulators say should avoid it? Germany, France and the Netherlands name pregnant and breastfeeding women. Germany and France add children and people with liver disease; France also names thyroid, heart and hyperandrogenism conditions [13][14][15].
Sources
- Akhgarjand C et al., Phytotherapy Research, “Does Ashwagandha supplementation have a beneficial effect on the management of anxiety and stress? A systematic review and meta-analysis of randomized controlled trials” (2022). https://pubmed.ncbi.nlm.nih.gov/36017529/ (abstract read via NCBI E-utilities; used for trial counts, effect sizes, certainty)
- Cheah KL et al., PLoS One, “Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis” (2021). https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0257843 (full text; bias ratings, funding, extract types)
- Arumugam V et al., Explore, “Effects of Ashwagandha (Withania Somnifera) on stress and anxiety: A systematic review and meta-analysis” (2024). https://pubmed.ncbi.nlm.nih.gov/39348746/ (abstract)
- Fatima K et al., Human Psychopharmacology, “Safety and efficacy of Withania somnifera for anxiety and insomnia: Systematic review and meta-analysis” (2024). https://pubmed.ncbi.nlm.nih.gov/39083548/ (abstract)
- Marchi M et al., BJPsych Open, “The effect of Withania somnifera (Ashwagandha) on mental health symptoms in individuals with mental disorders” (2025-10-27). https://pubmed.ncbi.nlm.nih.gov/41140145/ (abstract)
- Baune BT et al., J Integr Complement Med, “Ayurvedic Dravya-Based Herbal Products for Cognition, Stress, Sleep, and Psychiatric Symptoms” (2026). https://pubmed.ncbi.nlm.nih.gov/42359794/ (abstract)
- Chandrasekhar K et al., Indian J Psychol Med, RCT of a full-spectrum ashwagandha root extract (2012). https://pubmed.ncbi.nlm.nih.gov/23439798/ (abstract)
- Lopresti AL et al., Medicine (Baltimore), “An investigation into the stress-relieving and pharmacological actions of an ashwagandha extract” (2019). https://pubmed.ncbi.nlm.nih.gov/31517876/ (abstract, conflict statement)
- Langade D et al., Cureus, “Efficacy and Safety of Ashwagandha Root Extract in Insomnia and Anxiety” (2019-09-28). https://pubmed.ncbi.nlm.nih.gov/31728244/ (abstract)
- Salve J et al., Phytotherapy Research, “Safety of 12-Months Administration of Ashwagandha Standardized Root Extract in Healthy Adults” (2026). https://pubmed.ncbi.nlm.nih.gov/41063394/ (abstract)
- Björnsson HK et al., Liver International, “Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network” (2020). https://pubmed.ncbi.nlm.nih.gov/31991029/ (abstract)
- Bokan G et al., Pharmaceuticals, “Herb-Induced Liver Injury by Ayurvedic Ashwagandha as Assessed for Causality by the Updated RUCAM” (2023-08-10). https://pubmed.ncbi.nlm.nih.gov/37631044/ (abstract)
- Bundesinstitut für Risikobewertung (BfR), “Ashwagandha: food supplements with potential health risks”, Communication 39/2024 (2024-09-10). https://www.bfr.bund.de/cm/349/ashwagandha-food-supplements-with-potential-health-risks.pdf
- RIVM, “Risk assessment of herbal preparations containing Withania somnifera (Ashwagandha)”, report 2024-0029 (2024-03-05). https://www.rivm.nl/publicaties/risk-assessment-of-herbal-preparations-containing-withania-somnifera-ashwagandha (publication page read, not the 76-page report)
- ANSES, “Avis relatif aux risques liés à la consommation de compléments alimentaires contenant Withania somnifera”, saisine 2021-SA-0077 (2024-04-19). https://www.anses.fr/fr/system/files/NUT2021SA0077.pdf (read in French, conclusions and nutrivigilance sections)
- Fødevarestyrelsen (Danish Veterinary and Food Administration), “Ashwagandha i kosttilskud og drikkevarer” (undated page, read 2026-11-09). https://www.foedevarestyrelsen.dk/kost-og-foedevarer/alt-om-mad/kemi-i-maden/mad-med-uoensket-kemi/ashwagandha
- NutraIngredients, “Timeline: will authorities de-throne the king of herbs?” (2026-07-06). https://www.nutraingredients.com/Article/2026/07/06/timeline-will-authorities-de-throne-the-king-of-herbs/ (trade press; used for the 2023 Denmark date and EU Article 8 status only)
- NutraIngredients, “Ashwagandha armed with critical safety data as industry prepares for Europe-wide assessment” (2026-07-16). https://www.nutraingredients.com/Article/2026/07/16/ashwagandha-armed-with-critical-safety-data-as-industry-prepares-for-europe-wide-assessment/ (trade press)
- UK Food Standards Agency, “Summary of responses to call for evidence on ashwagandha” (2026-06-25). https://www.gov.uk/government/consultations/summary-of-responses-to-call-for-evidence-on-ashwagandha
- Medicine Today, “TGA safety advisory on Withania” (March 2024). https://medicinetoday.com.au/mt/2024/march/in-brief/tga-safety-advisory-withania (secondary summary; the TGA pages timed out)
- NCCIH, “Ashwagandha” (March 2023). https://www.nccih.nih.gov/health/ashwagandha
- @Hoostethics, “ranking the most cope supplements.” (2026-10-15). https://x.com/Hoostethics/status/2110728908735979632 (text and image read through the fxtwitter mirror)
This article is information, not medical advice.