Trimipramine
ATC code N06AA06
Also known as: Trimipramin
- Key facts
- Active substance
- Trimipramine
- Drug class
- Antidepressant
- ATC code
- N06AA06
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Boxed warning
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 trimipramine capsules 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.
Trimipramine capsules are not approved for use in pediatric patients. (See WARNINGS - Clinical Worsening and Suicide Risk, PRECAUTIONS - Information for Patients, and PRECAUTIONS - Pediatric Use)
Key facts
Trimipramine is a tricyclic antidepressant. Per the US prescribing information, it is used to relieve symptoms of depression; endogenous depression is more likely to respond than other forms.
What it is used for
- Relief of symptoms of depression
- Endogenous depression is more likely to be alleviated than other depressive states
Dosing
- Start low and increase gradually; lower doses for elderly patients, adolescents and outpatients
- Response usually takes ten days to four weeks; increasing the dose does not shorten this lag
- Outpatients: initially 75 mg/day in divided doses, increased to 150 mg/day; over 200 mg/day not recommended; maintenance 50 to 150 mg/day, possibly as a total dose at bedtime
- Hospitalized patients: initially 100 mg/day, increased over a few days to 200 mg/day; if no improvement in 2 to 3 weeks, up to the maximum of 250 to 300 mg/day
- Adolescent and geriatric patients: initially 50 mg/day, gradually up to 100 mg/day
- Maintenance preferably as a single bedtime dose, continued for about three months
Contraindications
- MAOIs for psychiatric disorders concurrently or within 14 days (either direction)
- Starting in a patient on linezolid or intravenous methylene blue
- Acute recovery period after myocardial infarction
- Possible cross-sensitivity with other dibenzazepines
Important warnings
- Boxed warning: increased risk of suicidal thinking and behavior in children, adolescents and young adults; monitor all patients for worsening; not approved for pediatric patients
- Serotonin syndrome, especially with other serotonergic drugs
- Pupillary dilation may trigger angle-closure glaucoma in patients with narrow angles
- Extreme caution in cardiovascular disease (conduction defects, arrhythmias); caution with urinary retention, hyperthyroidism and seizures
Side effects
- Cardiovascular: hypotension, hypertension, tachycardia, palpitation, arrhythmias, heart block
- Psychiatric: confusion (especially in the elderly), restlessness, insomnia, nightmares, hypomania
- Neurological: paresthesias, ataxia, tremors, extrapyramidal symptoms, seizures
- Anticholinergic: dry mouth, blurred vision, constipation, urinary retention; allergic: rash, photosensitization
Interactions
- MAOIs, linezolid, methylene blue: contraindicated
- Serotonergic drugs (e.g. triptans, fentanyl, lithium, tramadol, St. John's wort): serotonin syndrome
- P450 2D6 inhibitors and cimetidine: higher trimipramine levels, dose reduction may be needed
- Alcohol: exaggerated effects
Pregnancy and breastfeeding
- No adequate studies in pregnant women; embryotoxicity in animal studies; use only if the benefit justifies the risk to the fetus
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.
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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.
Germany
- StangylNeuraxpharm Arzneimittel Gmbh · 3 register entries
- Trimipramin1 A Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Aristo Pharma Gmbh (Art 57), Aliud Pharma Gmbh · 6 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Brand names in 6 more European countries
- France
- Surmontil
- Ireland
- Surmontil
- Italy
- Surmontil
- Norway
- Surmontil
- Portugal
- Surmontil
- Spain
- Surmontil
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
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Trimipramine (Breckenridge Pharmaceutical, Inc.) – Prescribing Information, 2026-03-17. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4f31df66-7dc2-1f04-e054-00144ff88e88
- 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
- Wikidata (CC0): ATC N06AA.
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.