Authors' objectives: BACKGROUND In Switzerland medicines containing valerian extract, either alone or with lemon balm, hops and/or other herbs are reimbursed by the Swiss mandatory health insurance to aid sleep and relief mild symptoms of mental stress and test anxiety. Valerian has gained popularity and the expenditure for valerian-based drugs in Switzerland have tripled since 2014. However, evidence on its clinical effectiveness is inconsistent in the literature. Therefore, there is a need to re-evaluate these medicines to support evidence-based decision making regarding the future reimbursement of these medicines by the Swiss mandatory health insurance. OBJECTIVE This HTA examines the clinical effectiveness, safety, cost-effectiveness, budget impact, ethical, legal, social and organisational aspects of medicines containing valerian extract, either alone or combined with lemon balm, hops and/or other herbal extracts to aid sleep and relief mild symptoms of mental stress and test anxiety. RESEARCH QUESTIONS Are medicines containing valerian (alone or in combination) efficacious, effective, safe and cost-effective compared to placebo, other herbal medicines, cognitive behavioural therapy, other medications, or no treatment (for symptoms of insomnia: also compared to lifestyle adaptation or improvement of sleep hygiene) in patients ≥ 6 years with symptoms of insomnia, mental stress or test anxiety? What is the budget impact of Dormiplant®, Hova®, Redormin®, Relaxane®, Sedonium® for the currently reimbursed populations? Are there ethical, legal, social or organisational issues related to the use of medicines containing valerian (alone or in combination) for treating symptoms of insomnia, mental stress or test anxiety?

Authors' results and conclusions: In total 36 studies were included (33 RCTs and 3 observational studies), 24 RCTs and 2 observational studies investigated valerian monotherapy in patients with insomnia, 7 RCTs evaluated valerian with lemon balm or hops in patients with insomnia, 3 RCTs and one observational study assessed valerian with lemon balm or hops in patients with mental stress and 2 RCTs examined valerian with lemon balm, passionflower and butterbur in patients with test anxiety/anxiety. For treatment with valerian monotherapy versus placebo in patients with insomnia, meta-analyses were conducted for sleep latency, sleep duration, sleep quality, night awakenings, sleep efficiency and Pittsburgh Sleep Quality Index (PSQI) total score. No statistically significant difference was observed between valerian and placebo for most outcomes. Two measures showed statistically significant improvements in favour of valerian: sleep quality at post-intervention assessment and PSQI total score. Of note, two of the three RCTs contributing to the post-intervention sleep quality analysis had a follow-up of only one day; when excluded, only one study with a 28-day follow-up remained, resulting in considerable uncertainty around this finding. Subgroup analyses excluding studies with follow-up durations shorter than 7 days and shorter than 14 days confirmed the main results for all other outcomes. When comparing valerian monotherapy versus benzodiazepine in patients with insomnia, meta-analyses could only be computed for sleep quality (for sleep latency, sleep duration and PSQI total score only one study was included) and no statistically significant difference was observed. Regarding treatment with valerian combined with hops or lemon balm versus placebo in patients with insomnia meta-analyses were conducted for sleep latency, sleep duration and sleep efficiency and no statistically significant differences were detected. For studies examining valerian combined with hops or lemon balm versus placebo in patients with mental stress, as well as those investigating valerian combined with lemon balm, passionflower and butterbur versus placebo in patients with test anxiety/anxiety, meta-analyses could not be computed as only one study per outcome was included. Regarding safety, a meta-analysis could only be computed for valerian combined with lemon balm, passionflower and butterbur versus placebo in patients with test anxiety/anxiety. No statistically significant difference was observed. For other comparisons, meta-analyses could not be computed due to fewer than two eligible studies being available. The certainty of evidence for the critical outcomes was judged as very low to moderate. No cost-effectiveness studies were identified in the literature. The budget impact analysis demonstrated substantial potential savings across 3 indication areas over a 5-year time horizon when removing valerian-containing medicines from reimbursement. The combined budget impact of all 5 valerian-containing medicines currently listed on the specialities list resulted in total savings of CHF 202.47 million, including medication costs, healthcare provider consultations and dependence-related healthcare costs associated with substitute treatments. For insomnia symptoms, the model projected savings of CHF 174.05 million. Mental stress symptoms showed estimated savings of CHF 6.14 million. Test anxiety symptoms yielded projected savings of CHF 22.28 million. Sensitivity analyses demonstrated parameter uncertainty of ± CHF 3.1 to 14.8 million across indications. Scenario analyses assuming continued prevalence growth projected higher savings of total CHF 244 million, comprising CHF 210 million for insomnia, CHF 7 million for mental stress and CHF 27 million for test anxiety. In a scenario where consumption volumes were aligned to real world claims data, total savings of CHF 222 million were projected, comprising CHF 173 million for insomnia, CHF 10 million for mental stress and CHF 39 million for test anxiety. The ethical, legal, social and organisational (ELSO) analysis identified key implications of delisting valerian preparations. Ethical considerations underscore that evidence-based resource allocation represents a fundamental principle in solidarity-based healthcare systems when making reimbursement decisions for collective resources. Legally, removal from reimbursement is justified when effectiveness criteria are unmet. Socially, vulnerable populations may face financial barriers requiring transition support. Organisationally, mental health services may experience increased demand and consultation times. Conclusion: This systematic review found no statistically significant differences between valerian preparations and placebo for most insomnia outcomes, except for sleep quality at postintervention assessment and PSQI scores, which favoured valerian. Evidence certainty ranged from very low to moderate. For mental stress and test anxiety/anxiety meta-analyses could not be computed. The budget impact analysis projected CHF 202 million savings over 5 years associated with delisting of valerian-containing medicines: CHF 174 million for insomnia symptoms, CHF 22 million for test anxiety symptoms and CHF 6 million for mental stress symptoms. ELSO analysis identified no insurmountable barriers to delisting given the insufficient evidence to demonstrate consistent effectiveness over placebo across outcomes, though transition planning for vulnerable populations is recommended to mitigate potential access issues.

Authors' methods: A systematic literature search in Cochrane Central Register of Controlled Trials (CENTRAL), Embase, Medline, PsycInfo and Web of Science databases was conducted. Eligible studies were randomised controlled trials (RCTs), non-randomised controlled trials and controlled observational studies that compared valerian (alone or in combination) with placebo, no treatment or any comparators approved for use in Switzerland. Where possible, meta-analyses were performed to estimate pooled effect estimates. Outcomes which could not be pooled with metaanalyses were summarised narratively by using the Synthesis Without Meta-analysis (SWiM) guideline. The methodological quality of included RCTs were critically appraised according to the Cochrane Risk of Bias tool 2 for randomised trials (RoB 2). The certainty of evidence was assessed for selected outcomes using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. A systematic literature search was conducted to identify published cost-effectiveness analyses. A de novo budget impact model was developed for the Swiss setting. The analysis adopted a healthcare payer perspective, focusing on costs covered by Swiss mandatory health insurance over a 5-year time horizon. Furthermore, a targeted search for evidence on the ethical, legal, social and organisational aspects of valerian was conducted and findings were qualitatively summarised and discussed.

Project Status: Completed

URL for project: https://www.bag.admin.ch/en/valerian-extracts-for-sleep-disorders-anxiety-or-restlessness

URL for protocol: https://www.bag.admin.ch/dam/en/sd-web/OnHegESeNE9l/h0080bsba_hta-protocol.pdf

Year Published: 2026

URL for published report: https://www.bag.admin.ch/dam/en/sd-web/ZTl39pfHxWgJ/h0080bsba_hta-report.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Switzerland

Organisation Name: Swiss Federal Office of Public Health (FOPH)

Contact Address: Federal Office of Public Health, Schwarzenburgstrasse 157, CH-3003 Berne, Switzerland

Contact Name: Stephanie Vollenweider

Contact Email: hta@bag.admin.ch

Copyright: Swiss Federal Office of Public Health