Prescription medicine
Trimipramine First approved as Surmontil
Trimipramine (Surmontil) is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the trimipramine FDA label on DailyMed (effective March 17, 2026, Breckenridge Pharmaceutical, Inc.); the NDA 16792 record on Drugs@FDA; every trimipramine label on DailyMed.
Highlights of the record
FDA label of March 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 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 )
Used for
From the label: indications and usageTrimipramine capsules are indicated for the relief of symptoms of depression.
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
Capsule.
On the market
- Earliest approval on file
- June 12, 1979 Surmontil, Teva Womens; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first August 2, 2006; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,476 through July 30, 2026
What is trimipramine used for?
From the label: indications and usageTrimipramine capsules are indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression.
Conditions named in the indications of trimipramine's FDA labels, with every medicine labeled for each:
From other trimipramine labelsDepression: INDICATIONS AND USAGE Trimipramine capsules are indicated for the relief of symptoms of depression.
FDA pharmacologic class: Tricyclic Antidepressant.
Source: FDA drug label (Trimipramine), Breckenridge Pharmaceutical, Inc., effective March 17, 2026 (SPL set 4f31df66-7dc2-1f04-e054-00144ff88e88), via openFDA; the full label on DailyMed
Is there a generic for trimipramine (Surmontil)?
The FDA approved the first generic trimipramine on August 2, 2006. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists trimipramine from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1979 earliest approval on file
- 2006 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the trimipramine label say about other medicines?
The trimipramine label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name trimipramine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | drug interactions | Therefore, particular care should be exercised when it is necessary to administer tricyclic antidepressants with sympathomimetic amines, local decongestants, local anesthetics containing epinephrine, atropine or drugs with an anticholinergic effect. |
| Buspirone | warnings | … serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous … |
| Cimetidine | drug interactions | Drug Interactions Cimetidine There is evidence that cimetidine inhibits the elimination of tricyclic antidepressants. |
| Epinephrine | drug interactions | Therefore, particular care should be exercised when it is necessary to administer tricyclic antidepressants with sympathomimetic amines, local decongestants, local anesthetics containing epinephrine, atropine or drugs with an anticholinergic effect. |
| Fentanyl | warnings | … particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also … |
| Flecainide | drug interactions | The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). |
| Fluoxetine | drug interactions | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. |
| Linezolid | contraindications | Starting trimipramine capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ). |
| Lithium | warnings | … with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as … |
| Methylene blue | contraindications | Starting trimipramine capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ). |
| Paroxetine | drug interactions | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. |
| Propafenone | drug interactions | The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). |
| Quinidine | drug interactions | The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). |
| Sertraline | drug interactions | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. |
Every other medicine the trimipramine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Tramadol | warnings | … (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both … |
Other labels that name trimipramine
Source: FDA drug label (Trimipramine), Breckenridge Pharmaceutical, Inc., effective March 17, 2026 (SPL set 4f31df66-7dc2-1f04-e054-00144ff88e88), via openFDA; the full label on DailyMed
What do FAERS reports show for trimipramine?
The FDA Adverse Event Reporting System holds 1,476 reports that list trimipramine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 244 are coded as a death and 776 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as trimipramine?
30 other medicines are given the same way (oral) and in the same FDA class as trimipramine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Doxepin | Depression | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
| Nortriptyline | Depression | 27 labelers | $0.113 per capsule 10 mg capsule | No current entry |
| Desipramine | Depression | 9 labelers | $0.276 per tablet 75 mg tablet | No current entry |
| Imipramine | Depression | 14 labelers | $0.0698 per tablet 10 mg tablet | No current entry |
| Amoxapine | Depression | 2 labelers | n/a | No current entry |
| Protriptyline | Depression | 2 labelers | $2.71 per tablet 10 mg tablet | No current entry |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
Every medicine labeled for the same conditions as trimipramine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to trimipramine
- 30 medicines for the same use
- Other tricyclic antidepressants
- the pharmacologic class, with prices and generics
- Trimipramine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other