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Triazolam

Halcion · ATC code N05CD05

Key facts
Active substance
Triazolam
Drug class
Benzodiazepine drug
ATC code
N05CD05
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

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 Warnings and Precautions (5.1), Drug Interactions (7.1)].
  • • The use of benzodiazepines, including triazolam, 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 triazolam 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 triazolam, 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 triazolam 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 triazolam or reduce the dosage [see Dosage and Administration (2.3), Warnings and Precautions (5.3)].

Key facts

Triazolam is a benzodiazepine hypnotic. Per the US prescribing information, it is used for the short-term treatment of insomnia (generally 7 to 10 days) in adults.

What it is used for

  • Short-term treatment of insomnia in adults, generally 7 to 10 days

Dosing

  • 0.25 mg once daily before bedtime; 0.125 mg may be sufficient for some patients (e.g. low body weight); 0.5 mg only if lower doses are inadequate; maximum 0.5 mg once daily
  • Elderly patients: start at 0.125 mg once daily; maximum 0.25 mg once daily
  • Use beyond 3 weeks requires evaluation for an underlying psychiatric or medical condition; prescriptions should not exceed a 1-month supply
  • Discontinue or reduce by gradual taper

Contraindications

  • Hypersensitivity to triazolam, its components or other benzodiazepines (angioedema has been reported)
  • Strong CYP3A inhibitors (e.g. ketoconazole, itraconazole, nefazodone, lopinavir, ritonavir)

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 or rapid dose reduction may cause life-threatening withdrawal reactions
  • Complex sleep behaviors such as sleep-driving; persistent or worsening insomnia; effects on driving the next day
  • Worsening of depression; neonatal sedation and withdrawal syndrome; compromised respiratory function

Side effects

  • Most common (more than placebo): drowsiness (14.0%), headache (9.7%), dizziness (7.8%), nervousness, light-headedness, coordination disorders/ataxia, nausea/vomiting
  • Less common: euphoria, tachycardia, confusional states/memory impairment, depression, visual disturbances
  • Serious: complex sleep behaviors, respiratory depression with opioids

Interactions

  • Opioids: risk of severe respiratory depression
  • Other CNS depressants: additive effects – limit dose and duration
  • Strong CYP3A inhibitors: contraindicated; moderate and weak inhibitors: caution and consider dose reduction
  • Strong CYP3A4 inducers: reduced effect; grapefruit juice increases triazolam levels

Pregnancy and breastfeeding

  • Use late in pregnancy may cause sedation and withdrawal symptoms in the newborn; observational data do not show a clear association with major birth defects

Summary of the official product information, written with AI on 2026-10-29. 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)

This product has no separate US patient information.

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

  • HalcionPfizer Corporation Austria Ges.M.B.H. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • HalcionPfizer Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 9 more European countries
Belgium
Halcion
Finland
Halcion
Ireland
Halcion
Italy
Halcion, Songar, Triazolam Doc Generici, Triazolam Eg, Triazolam Mylan Generics, Triazolam Pensa, Triazolam Ratiopharm Italia, Triazolam Sandoz, Triazolam Zentiva
Latvia
Halcion
Lithuania
Halcion
Luxembourg
Halcion
Portugal
Halcion
Spain
Halcion

EMA – Article 57 product data (EU/EEA), 2026-10-29

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

Other substances in the same group

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Sources

  1. U.S. Food and Drug Administration. Triazolam (Mylan Pharmaceuticals Inc.) – Prescribing Information, 2026-07-10. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5add318e-11b9-42f8-b052-0d8cebb32fcf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. 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), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. Wikidata (CC0): ATC N05CD.

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.