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Surmontil (TRIMIPRAMINE)
Surmontil (Trimipramine) is a tricyclic antidepressant developed by Odyssey Pharms and currently owned by Teva Women's. It targets the histamine H1 receptor and is used to treat depressive disorders. Surmontil is a small molecule with a half-life of 23.0 hours and bioavailability of 40%. It is off-patent and has multiple generic manufacturers. Key safety considerations include its potential for cardiac and anticholinergic side effects.
At a glance
| Generic name | TRIMIPRAMINE |
|---|---|
| Sponsor | Teva Womens |
| Drug class | Tricyclic Antidepressant |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1979 |
Approved indications
- Depressive disorder
Boxed warnings
- 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 maleate 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 maleate is not approved for use in pediatric patients. (See WARNINGS - Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients , and PRECAUTIONS: Pediatric Use .)
Common side effects
- Hypotension
- Hypertension
- Tachycardia
- Palpitation
- Myocardial infarction
- Arrhythmias
- Heart block
- Stroke
- Confusional states
- Hallucinations
- Disorientation
- Delusions
Drug interactions
- cimetidine
- alcohol
- catecholamines/anticholinergics
- drugs metabolized by P450 2D6
Key clinical trials
- Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial (PHASE2)
- Pharmacovigilance in Gerontopsychiatric Patients (PHASE3)
- YouScript IMPACT Registry
- Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene (PHASE4)
- Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Surmontil CI brief — competitive landscape report
- Surmontil updates RSS · CI watch RSS
- Teva Womens portfolio CI