Trimipramine is an active pharmaceutical ingredient in the Non-Selective Monoamine Reuptake Inhibitors group (N06AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 17, 2026[1]
Trimipramine has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses pronounced sedative action. It is, therefore, indicated in the treatment of depressive illness, especially where sleep disturbance, anxiety or agitation are presenting symptoms.
Sleep disturbance is controlled within 24 hours and true antidepressant action follows within 7 to 10 days.
How to take
CACanada· Health Canada
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How to take
CAOfficial regulatory label· revised March 22, 2025[2]
As with other psychotropic drugs, the dosage of TRIMIPRAMINE (trimipramine) should be adapted to the requirements of each individual patient. Treatment should be initiated at the lowest recommended dose and increased gradually, noting carefully the clinical response and any evidence of intolerance.
It should be kept in mind that a lag in therapeutic response usually occurs at the onset of therapy, lasting from several days to a few weeks. Increasing the dosage does not normally shorten this latent period and may increase the incidence of side effects.
Initial Dosage:
Adults: The recommended initial dose is 75 mg daily in two or three divided doses. Initial tolerance may be tested by giving the patient 25 mg in the evening of the first day. The initial dose should be increased by 25 mg increments, usually up to 150 mg daily, preferably by adding to the late afternoon and/or bedtime doses.
Drug interactions
Known interactions involving Trimipramine. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL177800638 · revised April 17, 2026
[2]Health Canada (DPD) · 00740799 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised April 17, 2026[1]
Adults For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day. Elderly 10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision.
Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response. Children Not recommended. Route of administration is oral.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[1]
4). Cardiac arrhythmias and severe hypotension are likely to occur with high dosage or in deliberate overdosage. They may also occur in patients with pre- existing heart disease taking normal dosage. 4) The following adverse effects, although not necessarily all reported with trimipramine, have occurred with other tricyclic antidepressants.
Atropine-like side effects including dry mouth, disturbance of accommodation, tachycardia, constipation and hesitancy of micturation are common early in treatment but usually lessen. Other common adverse effects include drowsiness, sweating, postural hypotension, tremor and skin rashes.
Interference with sexual function may occur. Serious adverse effects are rare; the following have been reported: depression of bone marrow, including agranulocytosis, cholestatic jaundice, hypomania, convulsions and peripheral neuropathy.
Psychotic manifestations including mania and paranoid delusions, may be exacerbated during treatment with tricyclic antidepressants. Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.
The mechanism leading to this risk is unknown. Hyperglycaemia. 4). Withdrawal symptoms may occur on abrupt cessation of therapy and include insomnia, irritability and excessive perspiration. Adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers had taken trimipramine during the last trimester of pregnancy.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[1]
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which Trimipramine is prescribed can also be associated with an increased risk of suicide-related events.
In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Hyperglycaemia/Diabetes:
Epidemiologic studies have identified an increased risk of diabetes mellitus in depressed patients receiving tricyclic antidepressants. 8). 5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 17, 2026[1]
• Recent myocardial infarction • Any degree of heart block or other cardiac arrhythmias • Mania • Severe liver disease • During breast feeding • Hypersensitivity to trimipramine maleate or to any of the excipients
This is not medical advice. Consult a qualified healthcare professional.
In the case of severely depressed patients, a higher initial dose of 100 mg daily in two or three divided doses may be indicated. The usual optimal dose is 150 to 200 mg daily, but some patients may require up to 300 mg daily, depending on tolerance and response of each individual patient.
5 to 25 mg and, after 45 minutes, examine the patient sitting and standing to check for orthostatic hypotension. Initial doses should usually be no more than 50 mg a day in divided doses, with weekly increments of no more than 25 mg a week, leading to a usual therapeutic dose range of 50 to 150 mg a day.
Blood pressure and cardiac rhythm must be checked frequently, particularly in patients who have unstable cardiovascular function.
Maintenance Dosage:
Once a satisfactory response has been obtained, the dosage should be adjusted to the lowest level required to maintain symptomatic relief. Medication should be continued for the expected duration of the depressive episode in order to minimize the possibility of relapse following clinical improvement.
10 When a maintenance dosage has been established as described above, trimipramine may be administered in a single dose before bedtime provided such a dosage regimen is well tolerated. 5 Description: Trimipramine maleate is a white or almost white, crystalline powder.
It is slightly soluble in water and in ethanol; freely soluble in chloroform; and practically insoluble in ether.
Composition Tablets:
In addition to trimipramine maleate, each tablet contains the non-medicinal ingredients microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide and FD&C red #3.
Capsules:
In addition to trimipramine maleate, each capsule contains the non-medicinal ingredients lactose, croscarmellose sodium, stearic acid, magnesium stearate, gelatin, sodium lauryl sulfate, sodium metabisulfite, FD&C red #3, D&C yellow #10, titanium dioxide and 12 FD&C blue #1.
The edible black printing ink on the capsule shell contains the non-medicinal ingredients synthetic black iron oxide, FD&C blue #1, FD&C blue #2, FD&C red #40, D&C yellow #10, pharmaceutical glaze, alcohol and propylene glycol. Stability and Storage Recommendations Protect from light.
Store at controlled room temperature 15-30°C (59-86°F). 5 mg of trimipramine. TRIMIPRAMINE (Trimipramine Tablets BP), 25 mg: each round, pink, biconvex, film-coated tablet, engraved "25 on one side, contains trimipramine maleate equivalent to 25 mg of trimipramine.
TRIMIPRAMINE (Trimipramine Tablets BP), 50 mg: each round, pink, biconvex, film-coated tablet engraved "50" on one side contains trimipramine maleate equivalent to 50 mg of trimipramine. TRIMIPRAMINE (Trimipramine Tablets BP), 100 mg: each round, pink, biconvex, film-coated tablet scored and engraved "100" on one side contains trimipramine maleate equivalent to 100 mg of trimipramine.
Capsules TRIMIPRAMINE (Trimipramine Capsules), 75 mg: each hard gelatin capsule with buff body and pink cap, printed "75", contains trimipramine maleate equivalent to 75 mg of trimipramine. TRIMIPRAMINE tablets and capsules are available in bottles of 100, 500 and 1000.
13 PHARMACOLOGY Like other tricyclic antidepressants trimipramine antagonizes reserpine induced ptosis, hypothermia and depression in mice and rats and post electroshock depression in the rabbit and in the rat. It potentiates the narcotic effect of ether and hexobarbital and depresses spontaneous activity in mice, but does not cause catalepsy and does not block significantly conditioned avoidance responses.
Trimipramine protects against maximal electroshock-induced convulsions, but lowers the threshold for metrazol-induced convulsions. In 'in vitro' tests, anti-serotonin and antihistaminic activities have been demonstrated. Trimipramine also possesses antiemetic and analgesic properties.
Like other tricyclic drugs, trimipramine potentiates the pressor effect of directly acting sympathomimetic amines. The drug also has anticholinergic properties. Trimipramine lowers the blood pressure in anesthetized dogs and induces tachycardia of short duration.
Like other tricyclic agents, trimipramine exerts a quinidine-like myocardial depressant effect in chloralose-anesthetized dogs.
TOXICOLOGY Acute Toxicity:
The LD50 of trimipramine in the mouse is 42 mg/kg intravenously, 425 mg/kg per os, 285 mg/kg subcutaneously, and 145 mg/kg intraperitoneally. At […]
This is not medical advice. Consult a qualified healthcare professional.
8). g. hypokalemia, hypomagnesemia). The elderly are particularly liable to experience adverse reactions, especially agitation, confusion and postural hypotension. Avoid if possible in patients with narrow angle glaucoma, symptoms suggestive of prostatic hypertrophy and a history of epilepsy.
Patients posing a high suicidal risk require close initial supervision. Tricyclic antidepressants potentiate the central nervous depressant action of alcohol. Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension.
If surgery is necessary, the anaesthetist should be informed that a patient is being so treated. It may be advisable to monitor liver function in patients on long term treatment with Trimipramine.