If you've searched "ashwagandha" recently, you've seen the headlines about liver injury. We sell a product with 600mg of ashwagandha in it — which gives us two options: hope you don't read those stories, or hand you the complete file ourselves. We built this brand on option two.
What the case reports actually say
The authoritative source is LiverTox, the NIH's reference database on drug- and supplement-induced liver injury. Its ashwagandha entry, together with a 2025 scoping review of published cases, describes roughly 20–35 published case reports worldwide of clinically apparent liver injury linked to ashwagandha. The typical pattern: a cholestatic or mixed injury appearing two to twelve weeks after starting, resolving on its own within one to five months after stopping. A small number of severe cases — including rare reports involving liver failure — exist in the literature and deserve to be named, not buried in a footnote.
Now the denominator: ashwagandha is one of the best-selling herbs in the world, taken daily by millions of people, and has been used for a very long time in Ayurvedic practice. Dozens of published cases against that usage base is the signature of a rare, idiosyncratic reaction — one that hits an unpredictable few rather than tracking dose or duration in any obvious way. That's meaningfully different from a compound that's toxic to everyone at high doses. It also means "rare" is not the same as "impossible," and no honest brand will tell you otherwise.
The regulatory map, unhidden
Europe has moved cautiously: Denmark banned ashwagandha in supplements in 2023 after a national risk assessment that flagged liver and hormonal concerns; an EU food-safety working group recommended prioritizing it for formal review in 2024; France's health agency advises against use by pregnant or breastfeeding women, minors, and people with thyroid or liver conditions. In the US, the FDA has taken no action, and ashwagandha remains a lawful dietary ingredient. We sell only in the US — but you deserve to know what other regulators think, not just the friendly ones.
What muddies the data — and what we do about it
Many published cases involve multi-herb blends, unlabeled doses, or products of unknown quality — which makes it genuinely hard to know what caused what. That's not an excuse; it's the reason our choices look the way they do:
- One standardized extract, not a blend. Night Reset uses KSM-66®, a single root-only extract standardized to 5% withanolides — so what's in the bottle is knowable and consistent.
- The studied dose, printed. 600mg per serving — the amount used in the clinical trials, not a mystery sprinkle and not a mega-dose.
- Third-party testing. Every batch goes to an independent lab, and we publish the certificate.
- No stacking by design. If you already take a separate ashwagandha product, don't take both — that's in our FAQ, and it applies here too.
Do these steps reduce an idiosyncratic risk to zero? No — nothing does, and we won't pretend otherwise. They remove the failure modes that are actually removable.
The stop-signs (please read this part)
Idiosyncratic liver reactions announce themselves. If, in your first weeks on any ashwagandha product — ours included — you notice dark urine, yellowing of the skin or eyes, pain in the upper right abdomen, persistent nausea, or unusual fatigue: stop taking it and see a doctor. Liver injury of this type usually resolves after stopping, and catching it early is what keeps it a footnote rather than a story. And if you have an existing liver condition, take medication that affects the liver, or have thyroid disease — talk to your doctor before starting, not after.
Why it's still in our formula
Because the benefit side of the file is real too: ashwagandha at 600mg is the best-evidenced botanical we know of for stress-related sleep trouble — a 2021 meta-analysis found its effects on sleep were strongest at exactly this dose over eight-plus weeks.† We weighed a rare, watchable, mostly reversible risk against the most consistent evidence base in the category, chose to keep it, and chose to arm you with the entire file. Adults making informed decisions is the whole premise of this brand — the studies, doses, and sources live in our Evidence Library, right next to this article.
†These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
KSM-66® is a registered trademark of Ixoreal Biomed. This article is educational and is not medical advice. If you experience possible symptoms of liver injury, stop use and seek medical care promptly.