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Amitriptyline

Saroten · ATC code N06AA09

Also known as: Amitriptylin, Amitriptilin · Brand names: Saroten, Amineurin, Amitriptylin Amarox, Amitriptylin Ct, Amitriptylin Fairmed Healthcare, Amitriptylin Micro Labs, Amitriptylin Neuraxpharm, Syneudon, Laroxyl

Key facts
Active substance
Amitriptyline
Drug class
Antidepressant
ATC code
N06AA09
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amitriptyline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Amitriptyline is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients and PRECAUTIONS: Pediatric Use.)

Key facts

Amitriptyline is a tricyclic antidepressant. Per the US label, it is indicated for the relief of symptoms of depression.

What it is used for

  • Relief of symptoms of depression; endogenous depression is more likely to respond than other depressive states
  • Not approved for use in pediatric patients

Dosing

  • Adult outpatients: usually 75 mg a day in divided doses, increased if necessary to 150 mg per day
  • Alternative start: 50 mg to 100 mg at bedtime, increased as needed to 150 mg per day
  • Hospitalized patients: 100 mg a day initially, up to 200 mg if necessary; a small number may need 300 mg
  • Adolescent and elderly patients: lower doses, e.g. 10 mg three times a day with 20 mg at bedtime
  • Maintenance: usually 50 mg to 100 mg per day, preferably as a single bedtime dose
  • Not recommended under 12 years of age

Contraindications

  • Prior hypersensitivity to amitriptyline
  • Concomitant monoamine oxidase inhibitors; allow at least 14 days after stopping an MAOI
  • Concomitant cisapride (QT prolongation, arrhythmia risk)
  • Acute recovery phase following myocardial infarction

Important warnings

  • Boxed warning: increased risk of suicidal thinking and behavior in children, adolescents and young adults
  • Patients of all ages should be closely observed for clinical worsening, suicidality and unusual behavior changes
  • A sedative effect may appear before the antidepressant effect
  • Elderly patients generally have higher plasma levels for a given dose and should be monitored carefully

Side effects

  • Cardiovascular: myocardial infarction, stroke, arrhythmias, heart block, orthostatic hypotension, tachycardia
  • CNS: seizures, hallucinations, confusional states, extrapyramidal symptoms, drowsiness, dizziness
  • Anticholinergic: dry mouth, constipation, urinary retention, blurred vision, paralytic ileus
  • Allergic: skin rash, urticaria, photosensitization

Interactions

  • MAO inhibitors: hyperpyretic crises, severe convulsions and deaths
  • Cisapride: increased risk of QT prolongation and arrhythmia

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

  • SarotenLundbeck Austria Gmbh · 1 register entry

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

Germany

  • AmineurinHexal Ag · 2 register entries
  • Amitriptylin AmaroxAmarox Pharma Gmbh · 2 register entries
  • Amitriptylin CtAbz-Pharma Gmbh · 1 register entry
  • Amitriptylin Fairmed HealthcareFairmed Healthcare Gmbh · 1 register entry
  • Amitriptylin Micro LabsMicro Labs Gmbh · 1 register entry
  • Amitriptylin NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
  • SyneudonFairmed Healthcare Gmbh · 1 register entry

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

Turkey

  • LaroxylDEVA HOLDİNG A.Ş. · 2 register entries

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

Brand names in 26 more European countries
Belgium
Redomex
Bulgaria
Амитрекс
Croatia
Amitriptilin Sandoz
Cyprus
Amirol
Czechia
Amitriptylin Slovakofarma
Denmark
Amitriptylin "eql Pharma", Amitriptylin Abcur, Saroten
Estonia
Amitriptyline Grindeks
Finland
Amitriptylin Abcur, Triptyl
France
Amitriptyline Biogaran, Amitriptyline Gerda, Amitriptyline Substipharm, Elavil, Laroxyl
Hungary
Teperinep
Iceland
Amitriptylin Abcur
Ireland
Amitriptyline Clonmel Healthcare, Amitriptyline Hydrochloride Pinewood Laboratories, Amitriptyline Hydrochloride Syri Pharma, Aniva, Astilin
Italy
Adepril, Amitriptilina Doc, Amitriptilina Eg, Amitriptilina Mylan, Laroxyl, Triptizol
Latvia
Amitriptyline Grindeks
Lithuania
Amitriptyline Grindeks, Amitriptylinum Viatris
Luxembourg
Amitriptylin Micro Labs, Redomex
Malta
Amirol, Amitriptyline Accord Healthcare, Aniva
Netherlands
Amitriptyline Bb, Amitriptyline Expharma, Amitriptyline Hcl Amarox, Amitriptyline Hcl Cf, Amitriptyline Hcl Strides, Amitriptyline Hcl Teva, Amitriptyline Hydrochloride Aurobindo, Amitriptyline Hydrochloride Focus Care
Norway
Amitriptylin Abcur, Amitriptylin Orifarm, Sarotex
Poland
Amitriptylinum Vp
Portugal
Adt
Romania
Amitriptilină Arena
Slovakia
Amitriptylin Slovakofarma
Slovenia
Amyzol
Spain
Amitriptilina Hidrocloruro Tarbis, Deprelio, Tryptizol
Sweden
Amitriptylin Abcur, Amitriptylin Orifarm, Saroten

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. AMITRIPTYLINE HYDROCHLORIDE (Aurobindo Pharma Limited) – Prescribing Information, 2026-04-02. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8085a37f-3c76-4f74-aab3-9a929a7eb1c2
  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. Wikidata (CC0): ATC N06AA.

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.