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Diazepam

Diazepam G.L., Diazepam Macure, Gewacalm, Psychopax · ATC code N05BA01

Brand names: Diazepam G.L., Diazepam Macure, Gewacalm, Psychopax, Stesolid, Diazepam Abz, Diazepam Accord, Diazepam Desitin, Diazepam Ratiopharm, Diazepam Stada, Diazepam Xilmac Macure Pharma, Diaksi, Diapam, Diazem, Diazepam Feblys …

Key facts
Active substance
Diazepam
Drug class
Benzodiazepine drug
ATC code
N05BA01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGSand PRECAUTIONS).
  • The use of benzodiazepines, including diazepam tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing diazepam tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS) .
  • The continued use of benzodiazepines, including diazepam tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of diazepam tablets after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATIONand WARNINGS) .

Key facts

Diazepam is a benzodiazepine. Per the US label it is used for anxiety disorders, acute alcohol withdrawal, muscle spasm and as an adjunct in convulsive disorders.

What it is used for

  • Anxiety disorders and short-term relief of anxiety symptoms
  • Acute alcohol withdrawal (agitation, tremor, impending or acute delirium tremens, hallucinosis)
  • Adjunct for skeletal muscle spasm, spasticity from upper motor neuron disorders, athetosis and stiff-man syndrome
  • Adjunct in convulsive disorders

Dosing

  • Anxiety: 2 mg to 10 mg, 2 to 4 times daily depending on severity
  • Alcohol withdrawal: 10 mg 3 or 4 times during the first 24 hours, then 5 mg 3 or 4 times daily as needed
  • Muscle spasm: 2 mg to 10 mg 3 or 4 times daily; convulsive disorders: 2 mg to 10 mg 2 to 4 times daily
  • Elderly or debilitated: 2 mg to 2.5 mg 1 or 2 times daily initially, increase gradually
  • Children (not under 6 months): 1 mg to 2.5 mg 3 or 4 times daily initially
  • Discontinue or reduce only with a gradual taper

Contraindications

  • Hypersensitivity to diazepam; children under 6 months
  • Myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, sleep apnoea syndrome
  • Acute narrow-angle glaucoma

Important warnings

  • Boxed warning: concomitant use with opioids may cause profound sedation, respiratory depression, coma and death
  • Boxed warning: risks of abuse, misuse and addiction, which can lead to overdose or death
  • Boxed warning: physical dependence; abrupt discontinuation may cause life-threatening withdrawal reactions
  • Paradoxical reactions, more likely in children and the elderly; anterograde amnesia may occur

Side effects

  • Most common: drowsiness, fatigue, muscle weakness, ataxia
  • Confusion, depression, headache, vertigo, blurred vision, hypotension
  • Paradoxical reactions (restlessness, aggressiveness, hallucinations, sleep disturbances)
  • Incontinence, urinary retention, libido changes, elevated transaminases

Interactions

  • Opioids: profound sedation, respiratory depression, coma and death; reserve for when alternatives are inadequate, at lowest doses and shortest durations
  • Alcohol and other CNS depressants increase the risk of serious outcomes

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Diazepam G.L.G.L. Pharma Gmbh · 1 register entry
  • Diazepam MacureMacure Pharma Aps · 1 register entry
  • GewacalmEvolan Pharma Ab · 1 register entry
  • PsychopaxSigmapharm Arzneimittel Gmbh · 1 register entry
  • StesolidActavis Group Ptc Ehf. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Diazepam AbzAbz-Pharma Gmbh · 1 register entry
  • Diazepam AccordAccord Healthcare B.V. · 1 register entry
  • Diazepam DesitinDesitin Arzneimittel Gmbh · 1 register entry
  • Diazepam RatiopharmRatiopharm Gmbh · 3 register entries
  • Diazepam StadaStadapharm Gmbh · 1 register entry
  • Diazepam Xilmac Macure PharmaMacure Pharma Aps · 1 register entry
  • StesolidPuren Pharma Gmbh & Co. Kg · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • DiaksiVEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • DiapamOSEL İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
  • DiazemDEVA HOLDİNG A.Ş. · 11 register entries
  • Diazepam DesitinMEDSAN İTHALAT İHRACAT İLAÇ SAN.TİC.LTD. ŞTİ. · 2 register entries
  • Diazepam FeblysARGİS İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • Diazepam-KoçakKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • LizanNOBEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • NerviumSABA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • ValiumRoche Laboratories Inc. · 1 register entry
  • ValtocoNeurelis, Inc · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries
Belgium
Diazepam Ab, Diazepam Eg, Diazepam Eurogenerics, Diazepam Teva, Diazetop, Valium
Bulgaria
Диазепам Актавис, Диазепам Софарма
Croatia
Apaurin, Dalpam, Diazepam Alkaloid, Diazepam Jgl, Normabel
Cyprus
Azepium, Kratium, Remedium
Czechia
Apaurin, Diazepam Desitin, Diazepam Slovakofarma, Diazepam Stada
Denmark
Apozepam, Diazepam Accord, Diazepam Dak, Diazepam Macure, Stesolid
Estonia
Diazepam Accord, Diazepam Basi, Diazepam Desitin, Diazepeks, Valocordin
Finland
Diapam, Diazepam Macure, Medipam, Stesolid
France
Diazepam Accord, Diazepam Arrow, Diazepam Renaudin, Diazepam Teva, Valium
Greece
Stedon
Hungary
Diazepam Desitin, Diazepeks, Seduxen
Iceland
Stesolid
Ireland
Anxicalm, Diazepam
Italy
Ansiolin, Diazepam Abc, Diazepam Alter, Diazepam Aurobindo, Diazepam Eg, Diazepam Mylan Generics, Diazepam Ratiopharm Italia, Diazepam Sandoz, Diazepam Zentiva, Micropam, Noan, Tranquirit, Valium, Vatran
Latvia
Diazepam Basi, Diazepeks, Relium
Lithuania
Apaurin, Diazepam Basi, Diazepam Polta, Diazepeks, Relanium, Relium
Luxembourg
Diazepam Eg, Diazepam Eurogenerics, Diazetop, Valium
Malta
Remedium, Stedon
Netherlands
Dalpam, Diazepam Accord, Diazepam Auro, Diazepam Aurobindo, Diazepam Cf, Diazepam Macure, Diazepam Rektiole Allgen, Diazepam Stada, Diazepam Syri Pharma, Diazepam Teva
Norway
Diazepam Macure, Stesolid, Valium, Vival
Poland
Diazepam Genoptim, Diazepam Grindeks, Neorelium, Relanium, Relsed
Portugal
Diazepam Aurobindo, Diazepam Basi, Diazepam Generis, Diazepam Grindeks, Diazepam Labesfal, Diazepam Pharmakern, Diazepam Ratiopharm, Garvera, Stesolid, Unisedil, Valium
Romania
Diazepam Desitin, Diazepam Laropharm, Diazepam Richter, Diazepam Terapia
Slovakia
Apaurin, Diazepam Desitin, Diazepam Grindeks, Diazepam Slovakofarma
Slovenia
Apaurin
Spain
Diazepam Aurovitas, Diazepam Basi, Diazepam Cinfa, Diazepam Durbán, Diazepam Grindeks, Diazepam Normogen, Diazepam Normon, Diazepam Pensa, Diazepam Qualigen, Diazepam Stada, Diazepam Vir, Diazepan, Stesolid, Valium
Sweden
Diazepam Accord, Diazepam Desitin, Diazepam Macure, Diazepam Orifarm, Stesolid

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Diazepam (Mylan Institutional Inc.) – Prescribing Information, 2025-07-18. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b326c66d-5762-4d16-933c-619fa2088ccd
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC N05BA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.