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Buspirone

Buspir, Buspon, Nopiron · ATC code N05BE01

Also known as: Buspiron

Key facts
Active substance
Buspirone
Drug class
Anxiolytic
ATC code
N05BE01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Buspirone is an anxiolytic indicated, per the US prescribing information, for the management of anxiety disorders or short-term relief of anxiety symptoms.

What it is used for

  • Management of anxiety disorders
  • Short-term relief of the symptoms of anxiety
  • Efficacy shown in trials of patients with generalized anxiety disorder, including those with coexisting depressive symptoms

Dosing

  • Initial dose 15 mg daily (7.5 mg b.i.d.)
  • May be increased by 5 mg per day at intervals of 2 to 3 days as needed
  • Maximum 60 mg per day; in trials divided doses of 20 mg to 30 mg per day were common
  • Take consistently either always with or always without food
  • With potent CYP3A4 inhibitors, specific dose recommendations apply (see full text)

Contraindications

  • Hypersensitivity to buspirone hydrochloride
  • MAOIs for depression used with buspirone or within 14 days of stopping either drug
  • Starting buspirone in patients treated with reversible MAOIs such as linezolid or intravenous methylene blue

Important warnings

  • Elevated blood pressure reported when added to an MAOI regimen
  • Serotonin syndrome possible, particularly with other serotonergic drugs (e.g. triptans), MAOIs or antipsychotics
  • Symptoms include agitation, hallucinations, tachycardia, hyperthermia, tremor, myoclonus, seizures and nausea
  • Patients should be monitored for emergence of serotonin syndrome

Side effects

  • More commonly observed: dizziness, nausea, headache, nervousness, lightheadedness, excitement
  • Discontinuation mainly due to CNS disturbances (dizziness, insomnia, drowsiness) and nausea

Interactions

  • MAOIs: serotonin syndrome and elevated blood pressure; at least 14 days apart
  • Linezolid or intravenous methylene blue: stop buspirone if these are urgently required
  • Potent CYP3A4 inhibitors: dose adjustment per label
  • Other serotonergic drugs increase the risk of serotonin syndrome

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.

Germany

  • BuspHexal Ag · 1 register entry

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

Turkey

  • BuspirSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • BusponDEVA HOLDİNG A.Ş. · 2 register entries
  • NopironNOBEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries

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

Brand names in 15 more European countries
Czechia
Buspiron-Egis
Denmark
Buripal, Buspiron Actavis, Buspirone Orion
Finland
Anksilon, Buspiron Ratiopharm
France
Buspirone Sandoz, Buspirone Viatris
Greece
Antipsichos, Bergamol, Bespar, Hobatstress, Lanamont, Ledion, Loxapin, Nevrorestol, Stressigal, Umolit
Hungary
Spitomin
Latvia
Spitomin
Lithuania
Spitomin
Netherlands
Buspiron Hcl Cf, Buspiron Hcl Mylan, Buspiron Hcl Sandoz
Norway
Buripal, Buspirone Orion
Poland
Spamilan
Portugal
Ansiten, Busansil, Buscalma, Buspirona Generis, Buspirone Orion, Itagil
Romania
Spitomin
Slovakia
Spitomin
Sweden
Anksilon, Buripal, Buspiron Actavis, Buspiron Newbury

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. Buspirone Hydrochloride (Mylan Pharmaceuticals Inc.) – Prescribing Information, 2026-06-15. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7c9eafb9-9ce1-4b28-900c-8fcb4b23424e
  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. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC N05BE.

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.