MS-N164 · Botanical sleep aid · Sleep support · Mixed cancers on treatment · Double-blind phase III trial · Appraised 28 October 2026

Does valerian improve sleep quality for people receiving chemotherapy, radiotherapy, endocrine therapy or other anticancer treatment?

Evidence at a glance

• Evidence label: Primary sleep endpoint negative
• Benefit: Valerian did not improve the prespecified Pittsburgh Sleep Quality Index outcome over eight weeks. Exploratory fatigue findings are hypothesis-generating only.
• Certainty: Moderate for no overall sleep benefit, tempered by substantial attrition: 227 were randomized but only 119 were evaluable for the primary endpoint.
• Risk: Short-term toxicities were similar to placebo, but valerian may add sedation, long-term safety is uncertain, and supplement–medicine interactions require review.

What was studied

Adults with cancer receiving active therapy were randomized to valerian 450 mg or matching placebo one hour before bedtime for eight weeks. The primary endpoint was the area under the curve of the Pittsburgh Sleep Quality Index. Functional sleep outcomes, fatigue, mood and toxicity were secondary. The trial was registered as NCT00075842.

What the evidence found

The eight-week PSQI AUC was 51.4 (SD 16) with valerian and 49.7 (SD 15) with placebo (P=0.6957). Exploratory fatigue measures and some patient-reported sleep items favored valerian, but these were secondary analyses after a negative primary result. Toxicity did not differ, except mild alkaline-phosphatase increases were slightly more common with placebo.

How to interpret it

A positive secondary outcome does not rescue a negative primary endpoint. The trial does not support valerian as a reliable sleep treatment during cancer therapy, and it measured symptoms—not cancer control.

Practical safety context

Avoid combining valerian with alcohol, sleep medicines, sedating antihistamines, opioids or other sedatives unless the prescribing team approves. Do not drive if drowsy. Persistent insomnia deserves assessment for pain, hot flashes, mood, sleep apnea, steroids and treatment timing.

Questions for the care team

• Could a medicine or treatment schedule be disrupting sleep?
• Would cognitive behavioral therapy for insomnia be more appropriate?
• Which sedating medicines or supplements am I already using?

Funding and conflicts

Conducted by the North Central Cancer Treatment Group and Mayo Clinic with U.S. Public Health Service/NCI grant support. Product-supply and detailed conflict information were not fully verified beyond the accessible report.

Sources

• Full text (PMCID PMC3052692)
• PubMed record (PMID 21399726)
• DOI 10.1016/j.suponc.2010.12.008
• ClinicalTrials.gov NCT00075842
• NCCIH valerian safety summary

Last literature search: 28 October 2026. Record appraisal: 28 October 2026. This page is educational and does not replace individualized medical advice. Symptom, biomarker or observational findings must not be interpreted as proof of tumor control, recurrence prevention or longer survival unless those outcomes were directly tested.