Herbal formula
Valerian and Hops
Also known as Ze 91019, Redormin 500, ReDormin Forte, Alluna Schlaf, Zeller Schlaf forte, valerian-hops combination, Baldrian-Hopfen
A fixed valerian root and hop cone extract tablet for sleep, approved in the EU, with small and mixed trial results.
Main use: Insomnia and sleep problems
Early or mixed evidence
2 ingredients
Updated October 10, 2026
Key points
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01
A fixed two-extract sleep tablet
Ze 91019 combines dry extracts of valerian root and hop cones. It is sold as Redormin 500 in Switzerland and under other names elsewhere.
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02
Small trials, mixed results
Small trials found shorter time to fall asleep or longer sleep, but the two largest placebo-controlled trials found modest or no clear benefit.
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03
EU-approved, on evidence EMA calls weak
EMA accepts specified valerian-hops extracts as well-established medicines for sleep disorders, while judging the supporting studies weak against its current guideline.
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04
Takes weeks, not one night
EMA recommends one or two doses half an hour to an hour before bed for four weeks. See a doctor if sleep is no better.
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05
Drowsiness, pregnancy, and age cautions
It may impair driving and adds to alcohol and sedatives. EMA does not recommend it in pregnancy, breastfeeding, or under 12. Chronic insomnia calls for CBT-I first.
Valerian and hops is one of Europe’s most familiar herbal sleep pairings: a tablet that combines a dry extract of valerian root (Valeriana officinalis) with a dry extract of hop cones (Humulus lupulus), the papery strobiles better known from beer. The best-studied version is a fixed extract combination with the research code Ze 91019, developed by the Swiss herbal medicine company Max Zeller Söhne AG and sold in Switzerland as Redormin 500. In Germany, Alluna Schlaf uses extracts with the same specifications, and a product with those specifications was tested in the United States in 2005. Many other valerian-hops tablets, tinctures, and teas exist, made with different solvents and strengths. The Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency (EMA) has a dedicated monograph for the combination, which accepts specified extract pairs as well-established medicines for the relief of sleep disorders, a stronger status than most herbal sleep aids hold.
Each herb has a long history as a sleep aid on its own, and the pairing is old too. Germany’s Commission E, the expert panel that reviewed herbal medicines for the German health authorities, published a monograph on valerian-hop combinations in 1991 for sleep problems caused by nervousness and restlessness, according to EMA’s assessment report. EMA’s first EU monograph on the combination was adopted in May 2010 and revised on 25 September 2019, based on products marketed in Germany, Austria, Hungary, Poland, Spain, the Czech Republic, Slovenia, and Sweden. In March 2025 the HMPC opened a periodic review of that monograph and invited new data until 30 June 2025. In the United States, valerian-hops products are sold as dietary supplements, which the Food and Drug Administration does not approve before they reach the market.
How the pair might work is not settled. In laboratory studies, valerian extracts in Ze 91019 acted as partial agonists at adenosine A1 receptors, part of the system that builds sleep pressure the longer we stay awake, and in healthy volunteers the combination blunted the brain-wave arousal caused by 200 mg of caffeine (Schellenberg and colleagues, Planta Medica 2004). Hop constituents interact with melatonin and serotonin receptors in laboratory work. EMA notes that many of these experiments used very high doses, states in its monograph that the mechanism of action is not known, and says it is not yet known whether hops act as a mild sedative on their own or strengthen valerian. This page covers what is in the main products, what trials of the combination itself found, how it is taken, and who should avoid it. Nothing here is medical advice.
See also
Herbs for Sleep02 The blend
What’s in it
Ingredients in label order. Results from trials of this formula belong to the combination, not to any single herb in it.
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Valerian · Root, dry extract
375 mg native dry extract per Redormin 500 tablet (older labels: 500 mg)
Valeriana officinalis
The main sedative ingredient, a methanol extract (drug-to-extract ratio 5–8:1). In Koetter’s small trial the same amount of valerian extract alone did not beat placebo, and EMA says the effect builds over weeks.
Read the valerian monograph →
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Hops · Strobile (cone), dry extract
84 mg native dry extract per Redormin 500 tablet (older labels: 120 mg)
Humulus lupulus
A methanol extract of hop cones (ratio 7–10:1). Hops alone have no sleep trials, and EMA says it is not known whether hops sedate on their own or strengthen valerian. Any 8-PN content is likely very small.
Read the hops monograph →
03 Evidence
What the research shows
Our rating for insomnia and sleep problems, based on trials of this combination.
The early studies of Ze 91019 were small and mostly sponsored by its maker. Füssel and colleagues (European Journal of Medical Research 2000), writing from Zeller, gave 30 patients with mild to moderate non-organic insomnia two tablets each evening, each containing 250 mg of valerian extract and 60 mg of hop extract. After two weeks, sleep laboratory recordings showed shorter time to fall asleep, less time awake, higher sleep efficiency, and more slow-wave sleep, and patients felt more refreshed, but there was no control group. EMA’s assessment report describes a placebo-controlled study by Rodenbeck and Hajek (1998) in only 15 patients that found the opposite change in deep sleep: less slow-wave sleep and more stage 2 sleep than placebo after four weeks. An open post-marketing study of 3,447 patients and an uncontrolled study of 144 patients reported high satisfaction and few side effects, but without placebo groups they cannot separate the tablet’s effect from expectation or natural improvement.
The trial most often cited for the combination is Koetter and colleagues (Phytotherapy Research 2007), led by a Zeller employee. Patients with non-organic insomnia and a sleep latency, the time taken to fall asleep, of at least 30 minutes were randomized to placebo, valerian extract alone (500 mg), or Ze 91019 (the same 500 mg of valerian plus 120 mg of hop extract) for four weeks, with sleep recorded at home by a portable device. The combination shortened sleep latency significantly more than placebo, and valerian alone did not, which the authors took as support for adding hops. EMA’s assessment report adds two important details: the trial had only 30 patients, 10 per group, and because of the small numbers it counted p = 0.10 as statistically significant, a looser threshold than the usual 0.05. No adverse events were reported. The result is suggestive, not proof that hops add to valerian.
The largest published trial is Morin and colleagues (Sleep 2005), run at nine US sleep disorder centers. It randomized 184 adults with mild insomnia to two nightly tablets of a valerian-hops combination (each 187 mg of valerian and 41.9 mg of hop extract, the same extract specifications as Ze 91019 products) for 28 days, placebo, or the antihistamine diphenhydramine for 14 days followed by placebo. Improvements in sleep diaries were modest, and few comparisons with placebo were statistically significant: by week 4, sleep latency had fallen by 9.5 minutes with valerian-hops versus 3.9 minutes with placebo (p = 0.0795), and total sleep time gains did not differ significantly. Overnight sleep recordings showed no differences between groups. The physical component of quality of life improved more with the combination, and there were no serious adverse events, next-day effects, or rebound insomnia. The study was sponsored by SmithKline Beecham, which analyzed the data, and co-author Koetter was a Zeller employee.
Two later trials point in different directions. Zeller sponsored a four-arm German replication (QUISI II, run 2008 to 2012) comparing two nightly tablets of the combination with valerian alone, hops alone, and placebo for four weeks. Its results synopsis, posted on the EU Clinical Trials Register in June 2022 and never published in a journal, reports 169 patients in the safety analysis but only 118 in the main analysis, because of numerous recording artifacts and missing values. The combination produced the largest mean drop in sleep latency, but it was not statistically better than placebo or either single extract. In 2025, Schicktanz and colleagues (Brain and Behavior) ran a Zeller-funded feasibility trial in 40 adults with occasional sleep problems, excluding people with diagnosed insomnia. Over 21 days, one Redormin 500 tablet nightly increased sleep duration measured by a Fitbit tracker by 21.7 minutes per night compared with placebo (p = 0.019), with no effect on reaction time, working memory, or mood. Those were exploratory outcomes, and three co-authors were Zeller employees.
Regulators and guideline writers read this record differently. EMA accepts two types of valerian-hops extract pairs, including the methanol extracts used in Ze 91019, as well-established medicines for sleep disorders, but its 2019 assessment calls the quality and outcomes of the supporting studies weak against its current guideline and kept the status because no new data changed the benefit-risk balance. Other combinations, including liquid extracts, are accepted only as traditional medicines. Other products have their own small studies: a 46-patient, two-week trial (Schmitz and Jäckel 1998) found similar improvement with a different valerian-hops tablet and with the benzodiazepine bromazepam. Salter and Brownie (Australian Family Physician 2010) reviewed 16 studies of valerian alone or with hops; 12 reported improvements in some sleep measures, but designs varied too much for confident recommendations. The American Academy of Sleep Medicine’s 2017 guideline suggests clinicians not use valerian for chronic insomnia, a weak recommendation framed around valerian in general rather than any specific product.
Much remains unknown. No published trial of the combination has lasted longer than four weeks, most were sponsored by the manufacturer, and participants mostly had mild or occasional sleep problems rather than chronic insomnia. EMA notes that no clinical studies have tested hops alone for sleep, and the only head-to-head comparisons with the single extracts are Koetter’s 30-patient trial and the unpublished QUISI II, which found no difference. Results also belong to the specific extract tested. A valerian-hops gummy, tea, or tincture made with water or ethanol at different ratios is not the same medicine as Ze 91019, and the broader valerian literature, with its own mixed findings, cannot be borrowed to fill the gaps. The fairest summary is that some people may fall asleep a little faster or sleep a little longer, that the effect is small and builds slowly, and that rigorous independent trials are still missing.
04 In practice
How it is taken
In Switzerland, Redormin 500 (Zeller Medical AG; leaflet last reviewed by Swissmedic in May 2025) declares 375 mg of valerian root dry extract and 84 mg of hop strobile dry extract per film-coated tablet, both made with methanol. Older Swiss leaflets and the trial papers described the same product as 500 mg and 120 mg, figures based on a non-native drug-to-extract ratio that counts added excipients; the current leaflet declares the native extract alone. In Germany, Alluna Schlaf (Repha GmbH; leaflet revised January 2024) contains 187.5 mg of valerian and 42.0 mg of hop extract per tablet, roughly half a Redormin 500 tablet, and its inactive ingredients include soy flour. EMA’s assessment report lists Austrian tablets with 374 mg and 84 mg. ReDormin Forte is sold in Australia, and US shelves carry many valerian-hops supplements with widely varying extracts. Only products that match EMA’s specified extracts can claim the trial evidence described here.
Trials used the equivalent of one Redormin 500 tablet a night: 500 mg of valerian and 120 mg of hop extract in Koetter’s trial, two 187 mg and 41.9 mg tablets in Morin’s, and one Redormin 500 tablet about an hour before bed in the 2025 trial. EMA’s monograph allows one or two doses half an hour to an hour before bedtime, not exceeding 500 mg of valerian extract, for adolescents, adults, and older people. The Swiss leaflet says one tablet an hour before bed for adults and adolescents from 12, and the German leaflet one to two tablets. Because the effect builds gradually, EMA says these combinations are not suitable for acute, same-night use and recommends four weeks of continuous use; if symptoms persist or worsen after four weeks, see a doctor. The Swiss leaflet advises medical help if complaints last more than a month.
When choosing a product, look for one that names both extracts, their drug-to-extract ratios and solvents, and the amount per tablet. A label that says only valerian 500 mg and hops 100 mg does not say whether those are raw herb or concentrated extract. Three-herb blends that add lemon balm or passionflower fall outside EMA’s valerian-hops monograph and have not been tested in the trials above. Stop and get checked if sleep has not improved after four weeks, if it is getting worse, or if new symptoms appear. A sleep tablet is best used alongside good sleep habits, and for insomnia lasting months it should not replace cognitive behavioral therapy for insomnia (CBT-I), which the American College of Physicians recommends as the first treatment for all adults with chronic insomnia. Ask a pharmacist to check the product against your other medicines.
05 Caution
Before you use Valerian and Hops
Side effects in the trials were few and mild. EMA lists gastrointestinal symptoms such as nausea and abdominal cramps, frequency unknown, and the Swiss leaflet adds vomiting, diarrhea, and abdominal pain, plus very rare skin reactions from inactive ingredients. In the 2025 trial, 9 adverse events occurred during treatment with the combination and 5 with placebo, not a significant difference, and the unpublished QUISI II recorded 4 adverse events among 169 patients. EMA found no reported withdrawal or rebound with the combination, and Morin found no rebound insomnia, but NCCIH notes that stopping valerian abruptly after long use may cause withdrawal symptoms, so taper after months of nightly use. Valerian has been linked to liver injury in very rare cases, most often in multi-herb products (NCCIH). The combination may impair driving (EMA): affected people should not drive or operate machinery, and a volunteer study found slightly slower arithmetic four hours after two tablets.
EMA does not recommend valerian-hops combinations during pregnancy or breastfeeding because safety has not been established, and no fertility data exist; the German leaflet says not to take it then, while the Swiss leaflet advises avoiding medicines or asking first. EMA does not recommend use under 12 years because of a lack of data. Switzerland is an exception: its Redormin 500 leaflet allows half a tablet from age 6. Persistent sleep problems in children deserve a pediatric assessment rather than a sedative. Anyone allergic to valerian or hops should avoid these products, and Alluna Schlaf is contraindicated with soy or peanut allergy because it contains soy flour. Memorial Sloan Kettering Cancer Center (MSKCC) advises people with liver, pancreatic, or gallbladder disease to avoid valerian, and people with hormone-sensitive cancers to consult their doctors before using hop products. EMA considers estrogenic 8-prenylnaringenin, if present at all in these extracts, likely to be in very small amounts.
EMA reports no drug interactions for the combination, but its assessment report notes that valerian may add to tiredness, dizziness, and sleepiness when taken with other sedating psychiatric drugs. NCCIH advises against taking valerian with alcohol or sedatives, and MSKCC warns that valerian lengthens sedation from barbiturates, benzodiazepines, and other central nervous system drugs. The same caution applies to Z-drugs such as zolpidem, opioids, sedating antihistamines like the diphenhydramine in many over-the-counter sleep aids, melatonin, and other sedating herbs. MSKCC advises stopping valerian at least a week before surgery because it may interact with anesthesia. For hops, laboratory studies suggest effects on several liver enzymes, but a standardized hop extract caused no clinically relevant enzyme interactions in people (MSKCC). Do not use a valerian-hops tablet to replace or taper a prescribed sleeping pill or benzodiazepine without your prescriber’s plan, and tell your doctor or pharmacist that you take it.
Some sleep problems need care rather than a remedy. Insomnia that lasts more than a few weeks is best assessed, and CBT-I, not a pill, is the recommended first treatment for chronic insomnia. Loud snoring, gasping, or pauses in breathing at night with daytime sleepiness suggest sleep apnea, which needs a sleep study; a sedative will not fix it. Sleeplessness with low mood, loss of interest, or anxiety may signal depression or an anxiety disorder, and thoughts of self-harm need urgent help from emergency services or a crisis line. An urge to move the legs at night, new sleep problems in an older person with falls or confusion, or sleep disrupted by pain, breathlessness, or frequent urination all need a medical look. Stop the product and seek care promptly for yellow skin or eyes, dark urine, pale stools, or persistent nausea, which can signal liver problems.
06 Questions
Frequently Asked Questions
Possibly a little, for some people. Small trials of the Ze 91019 extract found shorter time to fall asleep or about 20 minutes more sleep a night, but the largest published trial found only modest, mostly non-significant improvements over placebo, and an unpublished replication found no clear benefit. The single herbs are covered on the valerian and hops pages. For insomnia lasting months, CBT-I is the first-line treatment.
Ze 91019 is Max Zeller Söhne AG’s code for its fixed combination of a methanol valerian root extract and a methanol hop cone extract. It is sold as Redormin 500 in Switzerland, and Zeller’s German trial described Alluna as the same extract; today’s Alluna Schlaf lists matching extract specifications at about half the strength per tablet. Other valerian-hops products use different extracts and are not interchangeable.
Older Swiss leaflets and the trials described a Redormin 500 tablet as 500 mg of valerian and 120 mg of hop extract, counting added excipients. The May 2025 Swiss leaflet declares only the native extract, 375 mg and 84 mg. Both describe the same product, which is why comparing raw milligram numbers between brands can mislead.
EMA says the effect builds gradually, so the combination is not meant for occasional, same-night use, and it recommends four weeks of continuous use. If sleep has not improved or gets worse after four weeks, see a doctor. The Swiss leaflet advises medical help if complaints last more than a month.
Not clearly. In Koetter’s 2007 trial the combination beat placebo on time to fall asleep and valerian alone did not, but there were only 10 patients per group and a loose significance threshold. A larger Zeller-sponsored four-arm trial found no significant difference between the combination, the single extracts, and placebo. EMA says it is not known whether hops add to valerian’s effect.
It is best avoided without advice. NCCIH says valerian should not be taken with alcohol or sedatives, and MSKCC warns it can lengthen sedation from benzodiazepines and other central nervous system drugs. Melatonin, sedating antihistamines, and other calming herbs can add to drowsiness too. Do not swap a prescribed sleeping pill for this product without a prescriber’s plan, and do not drive if you feel drowsy.
EMA does not recommend it during pregnancy or breastfeeding because safety has not been established, or for children under 12 because of a lack of data. The Swiss Redormin 500 leaflet allows half a tablet from age 6, but sleep problems in children are better assessed by a pediatrician first.
Three-herb blends that add lemon balm or passionflower are common, but they fall outside EMA’s valerian-hops monograph and have not been tested in the trials described here. Each added herb brings its own cautions, and stacking sedating herbs adds to drowsiness.
07 References
Sources
These references support the claims on this page. They are not an endorsement of any product. Each ingredient’s monograph carries its own full source list.
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European Union herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos (Revision 1)
European Medicines Agency (EMA/HMPC/327107/2017), 2019
Adopted 25 September 2019: well-established use for sleep disorders; one or two doses before bed, maximum 500 mg valerian extract; four weeks of use; not under 12, in pregnancy, or breastfeeding; may impair driving; mechanism unknown.
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Assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos (Revision 1)
European Medicines Agency (EMA/HMPC/441766/2017), 2019
Trial summaries (Koetter 30 patients at p = 0.10; Morin; Rodenbeck; Schmitz); efficacy evidence judged weak but status kept; hop synergy unknown; 8-PN likely very small; Commission E 1991; three-herb blends out of scope.
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Call for scientific data for the periodic review of the monograph on Valerianae radix and Lupuli flos
European Medicines Agency (EMA/HMPC/110690/2025), 2025
Dated 19 March 2025: opens the periodic review of the valerian-hops monograph, with data accepted from 1 April to 30 June 2025.
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A randomized, double blind, placebo-controlled, prospective clinical study to demonstrate clinical efficacy of a fixed valerian hops extract combination (Ze 91019) in patients suffering from non-organic sleep disorder
Phytotherapy Research (PubMed 17486686), 2007
Koetter et al., first author at Max Zeller Söhne AG: Ze 91019 (500 mg valerian, 120 mg hops) shortened sleep latency vs placebo over four weeks; valerian alone did not.
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Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial
Sleep (PubMed 16335333), 2005
Morin et al.: 184 adults with mild insomnia, 28 days; modest subjective gains, no polysomnography differences, better physical quality of life, no rebound; sponsored by SmithKline Beecham.
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Effect of a fixed valerian-Hop extract combination (Ze 91019) on sleep polygraphy in patients with non-organic insomnia: a pilot study
European Journal of Medical Research (PubMed 11003973), 2000
Füssel et al. (Zeller AG): open pilot in 30 patients, two tablets of 250 mg valerian and 60 mg hops; shorter sleep latency and wake time after two weeks; no adverse events.
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Effects of a Valerian-Hops Extract Combination (Ze 91019) on Sleep Duration and Daytime Cognitive and Psychological Parameters in Occasional Insomnia: A Randomized Controlled Feasibility Trial
Brain and Behavior (PubMed 40462685), 2025
Schicktanz et al.: 40 adults, one Redormin 500 tablet for 21 days; exploratory 21.7 minutes more sleep per night by Fitbit; no cognitive effects; funded by Max Zeller Söhne AG.
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Clinical trial results: Ze 91019 (Alluna Nacht zum Einschlafen) compared with valerian or hops mono-extract (EudraCT 2007-005095-14)
EU Clinical Trials Register, 2022
Zeller-sponsored QUISI II synopsis: 169 patients, four arms, four weeks; no significant benefit of the combination over placebo or single extracts; many recording artifacts; 4 adverse events; not published in a journal.
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Redormin 500, Filmtabletten: Information für Patientinnen und Patienten
Zeller Medical AG, Swissmedic-approved patient information (Swissmedic 54152), 2025
Reviewed May 2025: 375 mg valerian and 84 mg hop native dry extract per tablet; one tablet an hour before bed from age 12, half from age 6; gastrointestinal side effects; see a doctor after one month.
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ALLUNA Schlaf Filmtabletten: Gebrauchsinformation
Repha GmbH Biologische Arzneimittel, 2024
Revised January 2024: 187.5 mg valerian and 42.0 mg hop dry extract per tablet; one or two tablets before bed; not under 12 or in pregnancy; may impair driving; contains soy flour.
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Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults
Journal of Clinical Sleep Medicine, American Academy of Sleep Medicine (PubMed 27998379), 2017
Sateia et al.: suggests clinicians not use valerian for sleep onset or sleep maintenance insomnia in adults (weak recommendation).
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Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians
Annals of Internal Medicine (PubMed 27136449), 2016
Qaseem et al.: recommends CBT-I as the initial treatment for all adults with chronic insomnia disorder (strong recommendation, moderate-quality evidence).
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Treating primary insomnia: the efficacy of valerian and hops
Australian Family Physician (PubMed 20628685), 2010
Salter and Brownie: 16 studies; 12 linked valerian alone or with hops to improvements in some sleep measures; designs too varied for confident recommendations.
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Valerian
National Center for Complementary and Integrative Health (NIH), 2025
Updated May 2025: inconsistent sleep evidence; avoid with alcohol or sedatives; withdrawal after abrupt stopping; very rare liver injury, mostly with multi-herb products.
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Valerian
Memorial Sloan Kettering Cancer Center, About Herbs, 2023
Stop at least a week before surgery; lengthens sedation from benzodiazepines and other CNS drugs; avoid with liver, pancreatic, or gallbladder disease.
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Hops
Memorial Sloan Kettering Cancer Center, About Herbs, 2021
People with hormone-sensitive cancers should consult their doctors before using hop products; no clinically relevant enzyme interactions with a standardized hop extract in humans.