Trazodone
Trittico · ATC code N06AX05
Also known as: Trazodon · Brand names: Trittico, Trazaxiro, Azona, Desyrel, Trumıo, Raldesy TM
- Key facts
- Active substance
- Trazodone
- Drug class
- Antidepressant
- ATC code
- N06AX05
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Boxed warning
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Trazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Key facts
Trazodone is an antidepressant used to treat major depressive disorder (MDD) in adults.
What it is used for
- Major depressive disorder in adults
- Not approved for pediatric patients
Dosing
- Initial dose 150 mg/day in divided doses; start low and increase gradually
- Increase by 50 mg/day every 3 to 4 days
- Outpatients usually not above 400 mg/day, inpatients not above 600 mg/day (divided doses)
- Drowsiness may require most of the dose at bedtime or a dose reduction; taken shortly after a meal or light snack
- Strong CYP3A4 inhibitors: consider dose reduction; strong inducers: consider dose increase
- At least 14 days between MAOIs and trazodone; gradual discontinuation
Contraindications
- Taking MAOIs (including linezolid or intravenous methylene blue) or within 14 days of stopping them
Important warnings
- Boxed warning: antidepressants increased suicidal thoughts and behaviors in pediatric and young adult patients; close monitoring
- Serotonin syndrome, cardiac arrhythmias, orthostatic hypotension and syncope
- Increased risk of bleeding; priapism
- Activation of mania/hypomania; screening for bipolar disorder before starting
- Cognitive and motor impairment, angle-closure glaucoma, hyponatremia
Side effects
- Common: drowsiness, dizziness/light-headedness, dry mouth, headache, nausea/vomiting, blurred vision
- Others: constipation, fatigue, nervousness, hypotension, syncope, confusion
- Serious: priapism, cardiac arrhythmias, serotonin syndrome
Interactions
- MAOIs contraindicated; other serotonergic drugs increase the risk of serotonin syndrome
- Strong CYP3A4 inhibitors and inducers alter trazodone exposure
Pregnancy and breastfeeding
- Studies over several decades have not identified drug-associated risks of major birth defects, miscarriage or adverse 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.
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For patients
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
- TritticoAngelini Pharma Oesterreich Gmbh · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- TrazaxiroMedical Valley Invest Ab · 1 register entry
- TrazodonHexal Ag, Neuraxpharm Arzneimittel Gmbh, Pharmaclan S.R.O., Glenmark Arzneimittel Gmbh, Stadapharm Gmbh, Aliud Pharma Gmbh · 6 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- AzonaSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- DesyrelANGELİNİ İLAÇ SAN. VE TİC. A.Ş. · 14 register entries
- TrumıoWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- Raldesy TMValidus Pharmaceuticals LLC · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 21 more European countries
- Belgium
- Nestrolan, Trazodone Eg, Trazodone Teva
- Bulgaria
- Тритико
- Croatia
- Trittico
- Cyprus
- Trazodone Mc, Trazodone Synto
- Czechia
- Azoneurax, Trazodon, Trittico Ac, Trittico Prolong
- Finland
- Azona
- Greece
- Trittico, Zotrad
- Hungary
- Trittico Ac, Trittico Xr
- Ireland
- Molipaxin, Trazodone Hydrochloride Accord Healthcare, Trazodone Hydrochloride Azure, Trazodone Hydrochloride Brillpharma (Ireland), Trazodone Hydrochloride Lexon Pharmaceuticals (Ireland)
- Italy
- Trazodone Eg, Trittico
- Latvia
- Trittico Retard
- Lithuania
- Trittico Retard
- Luxembourg
- Trazodone Eg
- Malta
- Trazodone Hydrochloride Azure, Trazodone Hydrochloride Syri Pharma, Trazodone Normon
- Netherlands
- Trazodon Hcl Sandoz, Trazodon Hcl Xiromed, Trazodon Hydrochloride Accord, Trazodone Hcl Genrx, Trazodone Hcl Sandoz
- Poland
- Azoneurax, Trazodone Neuraxpharm, Trittico Cr, Trittico Xr
- Portugal
- Trazodona Farmoz, Trazodona Generis, Trazodona Ratiopharm, Trazone Ac, Trazone Od, Triticum
- Romania
- Trittico Ac, Trittico Ep
- Slovakia
- Azoneurax, Trittico Ac
- Slovenia
- Trittico
- Spain
- Depraser, Deprax, Trazodona Cinfa, Trazodona Combix, Trazodona Normon, Trazodona Stada, Trazodona Stadafarma
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.
Other substances in the same group
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Trazodone Hydrochloride (Apotex Corp) – Prescribing Information, 2026-03-24. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=71961ab1-951d-1493-f76c-2ff25cca2a85
- 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
- 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
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC N06AX.
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.