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Alprazolam

Alprastad, Alprazolam Grindeks, Alprazolam Ratiopharm, Xanor · ATC code N05BA12

Brand names: Alprastad, Alprazolam Grindeks, Alprazolam Ratiopharm, Xanor, Tafil, Ansiox, Apo-Alpraz, Xanax

Key facts
Active substance
Alprazolam
Drug class
Benzodiazepine drug
ATC code
N05BA12
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for 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 Warnings and Precautions (5.1), Drug Interactions (7.1)].
  • The use of benzodiazepines, including alprazolam 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 alprazolam tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2)].
  • The continued use of benzodiazepines, including alprazolam 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 alprazolam 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 alprazolam tablets or reduce the dosage [see Dosage and Administration (2.2), Warnings and Precautions (5.3)].

Key facts

Alprazolam is a benzodiazepine. Per the US prescribing information, it is used in adults for the acute treatment of generalized anxiety disorder and for panic disorder.

What it is used for

  • Acute treatment of generalized anxiety disorder (GAD) in adults
  • Panic disorder, with or without agoraphobia, in adults

Dosing

  • GAD: start 0.25 mg to 0.5 mg three times daily; adjust every 3 to 4 days; maximum 4 mg daily in divided doses.
  • Panic disorder: start 0.5 mg three times daily; increase every 3 to 4 days by no more than 1 mg per day.
  • Above 4 mg per day: periodic reassessment and consideration of dose reduction.
  • Discontinue with a gradual taper: reduce by no more than 0.5 mg every 3 days.
  • Use the lowest effective dose; lower starting dose in patients already on an opioid.
  • Separate recommendations for geriatric patients and interacting drugs are in the full text.

Contraindications

  • Known hypersensitivity to alprazolam or other benzodiazepines (angioedema reported)
  • Concomitant strong CYP3A inhibitors (e.g. ketoconazole, itraconazole), except ritonavir

Important warnings

  • Boxed warning: use with opioids may cause profound sedation, respiratory depression, coma and death.
  • Boxed warning: risk of abuse, misuse and addiction, which can lead to overdose or death.
  • Boxed warning: dependence and withdrawal reactions; avoid abrupt discontinuation or rapid dose reduction.
  • Impaired ability to drive or operate machinery
  • Caution in patients with depression or impaired respiratory function

Side effects

  • GAD trials: drowsiness (41%), light-headedness (21%), dry mouth (15%)
  • Dependence and withdrawal reactions
  • Respiratory depression, especially with opioids
  • Neonatal sedation and withdrawal syndrome after use late in pregnancy

Interactions

  • Opioids: increased risk of respiratory depression and sedation; limit dose and duration
  • Strong CYP3A inhibitors (except ritonavir): contraindicated
  • Alcohol and other CNS depressants increase the risks

Pregnancy and breastfeeding

  • Neonates of mothers using benzodiazepines late in pregnancy have shown sedation and/or withdrawal.
  • Observational studies do not report a clear association with major birth defects.

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

  • AlprastadStada Arzneimittel Gmbh · 1 register entry
  • Alprazolam GrindeksGrindeks · 1 register entry
  • Alprazolam RatiopharmTeva B.V · 1 register entry
  • XanorViatris Healthcare Limited · 1 register entry

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

Germany

  • Alprazolam1 A Pharma Gmbh, Ratiopharm Gmbh, Grindeks, Abz-Pharma Gmbh, Tad Pharma Gmbh, Aliud Pharma Gmbh · 6 register entries
  • TafilViatris Pharma Gmbh · 1 register entry

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

Turkey

  • AnsioxPENSA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • Apo-AlprazAPOTEX İLAÇ SAN VE TİC. LTD. ŞTİ. · 1 register entry
  • XanaxVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 5 register entries

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

USA

  • XanaxPHARMACIA & UPJOHN COMPANY LLC · 1 register entry

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

Brand names in 27 more European countries
Belgium
Alpraz, Alprazolam, Xanax
Bulgaria
Алпразолам Гриндекс, Алпразолам Крка, Ксанакс, Мапразакс, Софанакс
Croatia
Alprazolam Grindeks, Alprazolam Krka, Helex, Maprazax, Misar, Xanax
Cyprus
Alprazolam Sapiens, Alprazolam Tad, Nalion, Xanax, Zolaram
Czechia
Alprazolam Grindeks, Alprazolam Krka, Alprox, Frontin, Helex Retard, Neurol, Xanax
Denmark
Alprazolam Grindeks, Alprazolam Krka, Alprazolam Mylan, Alprazolam Upjohn, Alprox, Tafil
Estonia
Alprazolam Grindeks, Alprazolam Krka, Alprazolam Orion, Ixhalanex, Xanax
Finland
Alprazolam Grindeks, Alprazolam Krka, Alprox, Xanor
France
Alprazolam Arrow, Alprazolam Biogaran, Alprazolam Cristers, Alprazolam Eg, Alprazolam Evolugen, Alprazolam Grindeks, Alprazolam Hcs, Alprazolam Sandoz, Alprazolam Teva, Alprazolam Viatris, Alprazolam Zentiva, Alprazolam Zydus, Xanax
Greece
Alprazolam Aurobindo, Alprazolam Grindeks, Saturnil, Xanax
Hungary
Alprazolam Alkaloid-Int, Alprazolam Grindeks, Frontin, Helex, Xanax
Iceland
Alprazolam Krka, Alprazolam Wh, Tafil
Ireland
Alprazolam Grindeks, Alprazolam Krka, Alprazolam Rowex, Gerax, Xanax
Italy
Alprazig, Alprazolam, Anelor, Frontal, Valeans, Xanax
Latvia
Alprazolam Grindeks, Alprazolam Orion, Frontin, Helex, Ixhalanex, Xanax
Lithuania
Alprazolam Grindeks, Alprazolam Orion, Altelek, Xanax, Zomiren
Luxembourg
Alpraz, Alprazolam Eg, Alprazolam Grindeks, Xanax
Malta
Alprazolam Aurobindo, Xanax, Zolaram
Netherlands
Alprazolam Aurobindo, Alprazolam Grindeks, Alprazolam Hexal, Alprazolam Ratiopharm, Alprazolam Retard Smb, Alprazolam Sandoz, Alprazolam Viatris, Xanax
Norway
Xanor
Poland
Afobam, Alpragen, Alpraxil, Alprazolam Aurovitas, Alprazolam Grindeks, Alprox, Neurol Sr, Xanax, Zomiren
Portugal
Alprazolam Aurobindo, Alprazolam Aurovitas, Alprazolam Basi, Alprazolam Bluepharma, Alprazolam Farmoz, Alprazolam Generis, Alprazolam Gp, Alprazolam Grindeks, Alprazolam Isab, Alprazolam Labesfal, Alprazolam Prazam, Alprazolam Ratiopharm, Alprazolam Sandoz, Alprazolam Tad, Alprazolam Tecnigen, Alprazolam Tolife, Alprazolam Vitória, Pazolam, Unilan, Xanax
Romania
Alprazolam Grindeks, Alprazolam Lph Labormed, Frontin, Xanax
Slovakia
Alprazolam Grindeks, Frontin, Helex, Neurol, Xanax
Slovenia
Alprazolam Grindeks, Aripsiq, Helex, Maprazax, Xanax
Spain
Alprazolam Alter, Alprazolam Aurovitas, Alprazolam Cinfa, Alprazolam Combix, Alprazolam Dermogen, Alprazolam Kern Pharma, Alprazolam Krka, Alprazolam Mabo, Alprazolam Neuraxpharm, Alprazolam Normon, Alprazolam Pensa, Alprazolam Sandoz, Alprazolam Stada, Alprazolam Stadafarma, Alprazolam Tarbis, Alprazolam Teva-Ratiopharm, Alprazolam Viatris, Trankimazin
Sweden
Alprazolam Grindeks, Alprazolam Krka, Alprazolam Orion, Alprazolam Stada, Xanor

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. Alprazolam (Natco Pharma USA LLC) – Prescribing Information, 2026-01-13. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b3c55877-2538-4892-bdb1-d618c643d29c
  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.