Generic Imipramine ( Imipramine )

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Imipramine (imipramine hydrochloride) is a tricyclic antidepressant (TCA) belonging to the dibenzazepine class of compounds. It is used primarily for the treatment of major depressive disorder and, in children aged 6 years and older, as a temporary adjunctive therapy for nocturnal enuresis (bedwetting). Imipramine works by inhibiting the reuptake of the neurotransmitters serotonin and norepinephrine into presynaptic nerve terminals, which increases their availability in the synaptic cleft and enhances mood‑regulating neurotransmission. It is the prototypical TCA and has been a cornerstone of antidepressant therapy since its introduction in the 1950s.

Usual adult dose: For depression in outpatients, treatment is typically started at 75 mg daily, which may be increased gradually to 150 mg daily; doses above 200 mg daily are generally not recommended for outpatients. For hospitalised patients, initial doses of 100 mg to 150 mg daily may be increased to 200 mg to 300 mg daily if needed. The daily dose may be given in divided doses or as a single dose at bedtime. The starting dose for elderly patients and adolescents is 30 mg to 40 mg daily, and it is generally not necessary to exceed 100 mg daily in these populations. For childhood enuresis (ages 6 and older), the initial dose is 25 mg given one hour before bedtime; this may be increased to 50 mg nightly in children under 12 years, or up to 75 mg nightly in children over 12 years.

Dosage form: Oral tablets available in strengths of 10 mg, 25 mg, 50 mg, and 75 mg. Capsules (as imipramine pamoate) are also available in some markets.

Onset of action: Some improvement in sleep, energy, or appetite may be noticed within the first 1 to 2 weeks of treatment. However, the full antidepressant effect typically requires 2 to 4 weeks of continuous therapy, and maximal benefit may take 4 to 6 weeks.

Duration of action: The elimination half‑life of imipramine is approximately 19 hours after a single dose and approximately 24 hours at steady‑state. Its active metabolite, desipramine, has a longer half‑life. This supports once‑daily dosing at bedtime or divided dosing throughout the day.

Alcohol recommendation: Alcohol consumption should be strictly avoided during treatment with Imipramine. Alcohol can potentiate the central nervous system depressant effects of imipramine, increase the risk of sedation, dizziness, and impaired coordination, and may worsen depression. Using imipramine with alcohol also increases the risk of suicidal thoughts or actions.

Most common side effects: Dry mouth, drowsiness, dizziness, blurred vision, constipation, difficulty urinating, weight gain, and orthostatic hypotension (a sudden drop in blood pressure upon standing). These anticholinergic and sedative effects are often dose‑dependent and may diminish over time or with dose adjustment.

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General Information about Imipramine

• INN (International Nonproprietary Name): Imipramine (as imipramine hydrochloride).
• Brand names available in Canada: Historically, the brand names Tofranil® and Tofranil 75MG (Novartis Pharmaceuticals Canada Inc.) were marketed, but both are now listed as "Cancelled Post Market" by Health Canada. Impril® (Valeant Canada LP) was also cancelled. Currently marketed generic products include APO‑Imipramine (Apotex Inc.), JAMP Imipramine (JAMP Pharma Corporation), AA Pharma Imipramine (AA Pharma Inc.), and PMS‑Imipramine (Pharmascience Inc.).
• ATC code: N06AA02.
• Dosage forms and strengths: Tablets (as imipramine hydrochloride): 10 mg, 25 mg, 50 mg, and 75 mg. Capsules (as imipramine pamoate): 75 mg, 100 mg, 125 mg, and 150 mg in some international markets.
• Manufacturers in Canada: Apotex Inc. (APO‑Imipramine), JAMP Pharma Corporation (JAMP Imipramine), AA Pharma Inc. (Imipramine), Pharmascience Inc. (PMS‑Imipramine), and other generic pharmaceutical companies. Historically, Novartis Pharmaceuticals Canada Inc. and Valeant Canada LP.
• Registration status in Canada: Approved by Health Canada. Multiple generic formulations are currently marketed and available by prescription. The original brand Tofranil is cancelled post‑market but generic equivalents remain widely available.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act.

Mechanism of Action and Pharmacology

Imipramine is the prototypical tricyclic antidepressant and a member of the dibenzazepine group of compounds. Its primary mechanism of action is the inhibition of the presynaptic reuptake of the monoamine neurotransmitters serotonin (5‑hydroxytryptamine, 5‑HT) and norepinephrine (NE). As a tertiary amine TCA, imipramine is a more potent inhibitor of serotonin reuptake than secondary amine TCAs such as its own active metabolite, desipramine. By blocking the serotonin transporter (SERT) and the norepinephrine transporter (NET), imipramine increases the synaptic concentration and prolongs the availability of these monoamines, thereby enhancing monoaminergic neurotransmission in regions of the brain associated with mood regulation.

In addition to monoamine reuptake inhibition, imipramine possesses a broad range of receptor‑binding properties that account for both its therapeutic effects and its side‑effect profile. It is a potent antagonist at histamine H₁ receptors (causing sedation and weight gain), muscarinic cholinergic receptors (causing dry mouth, blurred vision, constipation, and urinary retention), and alpha‑1 adrenergic receptors (causing orthostatic hypotension). These anticholinergic, antihistaminergic, and antiadrenergic effects are responsible for many of the tolerability issues associated with imipramine. Imipramine also blocks sodium channels in the heart and brain, which contributes to its cardiotoxicity in overdose and its proconvulsant potential at high doses. Compared with amitriptyline and clomipramine, imipramine has somewhat less sedative and anticholinergic effects.

Following oral administration, imipramine is well absorbed from the gastrointestinal tract, with peak plasma concentrations reached approximately 2 to 6 hours after dosing. The drug undergoes extensive first‑pass hepatic metabolism, primarily via cytochrome P450 isoenzymes CYP2C19 (demethylation to the active metabolite desipramine) and CYP1A2, with further metabolism of both imipramine and desipramine by CYP2D6 to less active hydroxylated metabolites. The elimination half‑life of imipramine is approximately 19 hours after a single dose and approximately 24 hours at steady‑state. Desipramine has a longer half‑life of 12 to 54 hours. Steady‑state plasma concentrations are achieved after approximately 3 to 7 days of regular dosing. The drug is excreted primarily in the urine as metabolites, with a smaller fraction eliminated in the faeces. Imipramine is highly protein‑bound (approximately 60‑96%). Therapeutic drug monitoring is recommended, with a target reference range of 150 to 300 ng/mL for the combined concentration of imipramine and desipramine.

Indications

• Major Depressive Disorder (MDD): For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. Imipramine may be used in hospitalised or outpatient settings.
• Nocturnal Enuresis (Bedwetting): As temporary adjunctive therapy in the treatment of nocturnal enuresis in children aged 6 years and older, after organic causes have been excluded. A drug‑free period should be instituted periodically.
• Off‑label Uses: Imipramine is prescribed off‑label for a variety of conditions, including panic disorder (with or without agoraphobia), attention‑deficit hyperactivity disorder (ADHD) as a second‑line agent, neuropathic and chronic pain (including diabetic neuropathy), post‑traumatic stress disorder (PTSD), generalised anxiety disorder (GAD), bulimia nervosa, and urinary urge incontinence.
• Imipramine is not approved for the treatment of bipolar depression, and it should not be used in patients under 6 years of age. The safety and efficacy of imipramine capsules for depression in the paediatric population have not been established.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: There are no adequate and well‑controlled studies of imipramine in pregnant women. It should be used during pregnancy only if the potential benefit clearly justifies the potential risk to the foetus. Neonates exposed to tricyclic antidepressants late in the third trimester may experience withdrawal symptoms including respiratory distress, feeding difficulties, and seizures. Women of childbearing potential should use effective contraception during treatment.
• Breastfeeding: Imipramine passes into breast milk in small amounts. Side effects have not been commonly reported in nursing infants, and follow‑up information on infant growth and development is limited but reassuring. However, the American Academy of Pediatrics classifies this drug as an agent whose effects on the nursing infant are unknown but may be of concern. A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the medication to the mother. If breastfeeding is continued, the infant should be monitored for sedation, irritability, and feeding difficulties.
• Paediatrics (< 6 years): Safety and efficacy have not been established in children younger than 6 years of age. For enuresis, imipramine is approved only for children aged 6 years and older. For depression, imipramine is not approved for use in paediatric patients of any age. Antidepressants increase the risk of suicidal thinking and behaviour in children, adolescents, and young adults in short‑term studies.
• Elderly: Elderly patients are particularly sensitive to the anticholinergic, sedative, and hypotensive effects of imipramine. They are at increased risk for orthostatic hypotension, confusion, falls, delirium, and cardiac arrhythmias. Imipramine is included in the Beers Criteria as a potentially inappropriate medication for older adults due to its strong anticholinergic and sedative effects. If use is necessary, the lowest effective dose should be employed, with careful monitoring. A baseline electrocardiogram (ECG) and periodic cardiac monitoring are recommended.
• Hepatic impairment: Imipramine is extensively metabolised by the liver. Use with caution and start with lower doses in patients with hepatic impairment, as clearance may be reduced. Liver function tests should be monitored periodically.
• Renal impairment: Caution is advised in patients with significant renal impairment, as drug and metabolite clearance may be reduced.
• Cardiovascular disease: Imipramine should be used with extreme caution in patients with pre‑existing cardiovascular conditions, including conduction disorders, arrhythmias, recent myocardial infarction, and heart failure. TCAs can cause QT interval prolongation, tachycardia, and orthostatic hypotension. A baseline ECG should be considered before initiating therapy, and periodic monitoring is recommended, particularly at doses above 150 mg daily. Imipramine is contraindicated during the acute recovery phase after a myocardial infarction.
• Angle‑closure glaucoma: Imipramine can cause pupillary dilatation, which may trigger an acute attack of angle‑closure glaucoma in susceptible individuals. Patients at risk should have an ophthalmologic evaluation before starting therapy.
• Urinary retention: Imipramine should be used with caution in patients with a history of urinary retention or benign prostatic hyperplasia, as its anticholinergic effects can impair bladder emptying.
• Seizure disorders: TCAs can lower the seizure threshold. Imipramine should be used with caution in patients with epilepsy or a history of seizures. EEG monitoring may be considered in high‑risk patients.
• Bipolar disorder: Screen for bipolar disorder before initiating treatment. Imipramine may precipitate a manic or hypomanic episode in patients with undiagnosed bipolar disorder, and TCAs are associated with a greater risk of mood switching than other classes of antidepressants. Discontinue use in any patient entering a manic phase.
• Suicidality: Antidepressants, including imipramine, carry a boxed warning for an increased risk of suicidal thinking and behaviour in children, adolescents, and young adults aged 24 years and under during the first few months of treatment. All patients should be closely monitored for clinical worsening, suicidality, or unusual changes in behaviour, particularly when starting therapy or after dosage changes. Families and caregivers should be advised of the need for close observation and to report concerns promptly.
• Serotonin syndrome: A potentially life‑threatening serotonin syndrome may occur with imipramine, particularly when combined with other serotonergic drugs. Symptoms include mental status changes (agitation, confusion, coma), autonomic instability (hyperthermia, tachycardia, labile blood pressure, diaphoresis), neuromuscular abnormalities (hyperreflexia, myoclonus, rigidity, tremor), and gastrointestinal symptoms (nausea, vomiting, diarrhoea). Immediate discontinuation of the offending agents and emergency medical care are required.
• Photosensitivity: Imipramine may increase the skin's sensitivity to sunlight. Patients should avoid prolonged sun exposure and use sunscreen.
• Allergy: Do not take Imipramine if you have a known hypersensitivity to imipramine hydrochloride, other dibenzazepine compounds, or any excipient in the formulation.

Driving and alcohol

Imipramine can cause significant drowsiness, dizziness, blurred vision, and impairment of cognitive and motor skills. These effects are most pronounced during the first few weeks of therapy and after dose increases. Patients should not drive, operate heavy machinery, or engage in potentially hazardous activities until they have determined how the medication affects them. Alcohol must be strictly avoided during treatment with Imipramine. Alcohol potentiates the central nervous system depressant effects of imipramine, increases the risk of profound sedation and respiratory depression, and may worsen the underlying depression or anxiety disorder. The concurrent use of imipramine and alcohol may also increase the risk of suicidal thoughts or actions.

Dosage Instructions

• Major Depressive Disorder (Adult Outpatients): The initial dose is 75 mg orally once daily, or in divided doses. The dose may be gradually increased to 150 mg daily. Doses above 200 mg daily are generally not recommended for outpatients. Maintenance doses range from 50 mg to 150 mg daily. The total daily dose may be given as a single dose at bedtime or in divided doses throughout the day.
• Major Depressive Disorder (Adult Hospitalised Patients): The initial dose is 100 mg to 150 mg daily in divided doses. The dose may be gradually increased to 200 mg daily. If no response is observed after 2 weeks, the dose may be further increased to 250 mg to 300 mg daily. The maximum dose is 300 mg daily, given in divided doses or as a single bedtime dose.
• Elderly and Adolescent Patients: The initial dose is 30 mg to 40 mg daily. It is generally not necessary to exceed 100 mg daily. Doses should be initiated at a low level and increased gradually, with careful monitoring for clinical response and any evidence of intolerance.
• Childhood Enuresis (Ages 6 and Older): The initial dose is 25 mg given orally one hour before bedtime. If a satisfactory response does not occur within one week, the dose may be increased to 50 mg nightly in children under 12 years. Children over 12 years may receive up to 75 mg nightly. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. For early night bedwetters, the drug may be more effective when given earlier and in divided amounts (e.g., 25 mg in midafternoon, repeated at bedtime). A dose of 2.5 mg/kg/day should not be exceeded.
• Administration: Imipramine tablets should be taken with a full glass of water. They may be taken with or without food, although taking with food may reduce gastrointestinal upset. If a single daily dose is prescribed, it is best taken at bedtime to minimise daytime drowsiness. Swallow tablets whole; do not crush or chew.
• Missed dose: If a dose is missed, take it as soon as remembered. If it is close to the time of the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose.
• Discontinuation: Abrupt discontinuation should be avoided. The dose should be gradually tapered under medical supervision to minimise the risk of withdrawal symptoms, which may include nausea, headache, malaise, and sleep disturbance. In children treated for enuresis, a drug‑free period should be instituted periodically following an adequate therapeutic trial.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Dry mouth, drowsiness, dizziness, blurred vision, and constipation. Weight gain is also common.
• Common side effects (1‑10%): Nausea, vomiting, diarrhoea, abdominal cramps, increased appetite, fatigue, weakness, headache, tremor, nervousness, insomnia, confusion (especially in the elderly), difficulty urinating (urinary retention), sexual dysfunction (decreased libido, erectile dysfunction, delayed ejaculation), and excessive sweating. A black tongue has been reported in isolated cases.
• Less common but serious side effects: Cardiac conduction disturbances (QT interval prolongation, bundle‑branch block, arrhythmias, tachycardia), syncope (fainting), orthostatic hypotension, myocardial infarction, stroke, seizures, neuroleptic malignant syndrome (NMS), agranulocytosis, leukopenia, thrombocytopenia, jaundice, hepatitis, syndrome of inappropriate antidiuretic hormone secretion (SIADH), and photosensitivity. Activation of mania or hypomania may occur, particularly in patients with bipolar disorder.
• Paediatric‑specific: In children treated for enuresis, nervousness, sleep disorders, tiredness, and mild gastrointestinal disturbances have been reported. ECG changes of unknown significance have been observed in paediatric patients receiving doses twice the recommended maximum of 2.5 mg/kg/day.
• Withdrawal symptoms: Abrupt discontinuation after prolonged therapy may produce nausea, headache, malaise, irritability, and nightmares. Gradual tapering is recommended.
• Overdose: An overdose of imipramine is a medical emergency that can be fatal. Symptoms of acute overdose include severe drowsiness, stupor, coma, respiratory depression, cardiac arrhythmias, severe hypotension, convulsions, and cardiac arrest. Children are particularly susceptible to imipramine overdose, which may be fatal even at relatively low doses. Immediate hospitalisation is required, with continuous cardiac monitoring and supportive care.
• Contraindications: Hypersensitivity to imipramine hydrochloride, other dibenzazepine compounds, or any excipient in the formulation. Concomitant use with monoamine oxidase inhibitors (MAOIs), including linezolid and intravenous methylene blue, or within 14 days of discontinuing MAOI therapy. Narrow‑angle glaucoma (untreated). Acute recovery phase of a myocardial infarction. Severe urinary retention. Use of imipramine in patients with known cardiac conduction abnormalities should be undertaken only with extreme caution and under specialist supervision.

Drug Interactions

• Monoamine oxidase inhibitors (MAOIs) — contraindicated: Concomitant use of imipramine with MAOIs (e.g., phenelzine, tranylcypromine, isocarboxazid, linezolid, intravenous methylene blue) is strictly contraindicated. This combination can cause serotonin syndrome, hypertensive crisis, and fatal reactions. A minimum 14‑day washout period must be observed between discontinuing an MAOI and starting imipramine, and vice versa.
• Serotonergic drugs — monitor closely: Co‑administration of imipramine with other serotonergic agents increases the risk of serotonin syndrome. These include selective serotonin reuptake inhibitors (SSRIs), serotonin‑norepinephrine reuptake inhibitors (SNRIs), triptans, fentanyl, lithium, tramadol, buspirone, St. John's wort, and tryptophan. If concomitant use is clinically necessary, patients should be monitored for signs and symptoms of serotonin syndrome.
• Strong CYP2D6 inhibitors — monitor and adjust: Drugs that strongly inhibit CYP2D6 (e.g., fluoxetine, paroxetine, bupropion, quinidine, terbinafine) can significantly increase imipramine plasma concentrations, increasing the risk of adverse effects, including cardiotoxicity. A reduction in the imipramine dose may be required. Therapeutic drug monitoring is recommended.
• Strong CYP2C19 inhibitors and inducers: CYP2C19 is the primary enzyme responsible for the demethylation of imipramine to desipramine. Strong CYP2C19 inhibitors can increase imipramine exposure, while CYP2C19 inducers (e.g., rifampin) can decrease it. Dose adjustments based on clinical response and therapeutic drug monitoring are recommended. In CYP2C19 poor metabolisers, a significant dose reduction is advised.
• CYP3A4 inducers — potential loss of efficacy: Carbamazepine, phenytoin, rifampin, and other strong CYP3A4 inducers can decrease imipramine plasma levels, reducing its therapeutic efficacy. An increase in the imipramine dose may be necessary.
• CNS depressants — additive sedation: Alcohol, benzodiazepines, opioids, sedating antihistamines, barbiturates, and other central nervous system depressants may potentiate the sedative and psychomotor‑impairing effects of imipramine. Patients should be advised against driving or operating machinery when such combinations are used.
• Anticholinergic agents — additive anticholinergic effects: Concomitant use of imipramine with other drugs possessing anticholinergic properties (e.g., antihistamines, antipsychotics, antispasmodics) may increase the risk of dry mouth, constipation, blurred vision, urinary retention, and confusion, particularly in the elderly.
• Antihypertensive agents — possible antagonism: Imipramine may antagonise the antihypertensive effects of guanethidine, clonidine, and related compounds. Blood pressure should be monitored closely.
• Sympathomimetic agents — potentiation: Imipramine may potentiate the cardiovascular effects of sympathomimetic amines such as epinephrine, norepinephrine, and phenylephrine, increasing the risk of hypertension and cardiac arrhythmias. Caution is advised when co‑administering these agents, including local anaesthetics containing epinephrine.
• QT‑prolonging drugs — increased cardiac risk: Co‑administration of imipramine with other drugs known to prolong the QT interval (e.g., certain antiarrhythmics such as disopyramide, ibutilide, and sotalol; fluoroquinolone antibiotics; some antipsychotics) may increase the risk of cardiac arrhythmias, including torsades de pointes. These combinations should be avoided when possible, or used with ECG monitoring.
• Drugs that affect electrolytes: Medications that can lower potassium or magnesium levels (e.g., certain diuretics such as indapamide) will increase the risk of QT prolongation and ventricular arrhythmias when used with imipramine.
• Cimetidine: May increase imipramine plasma levels by inhibiting hepatic metabolism. Dose adjustment of imipramine may be required.
• Anaesthetics: Caution is advised when imipramine is used with general anaesthetics, as the combination may increase the risk of cardiac arrhythmias and hypotension. Inform the anaesthetist prior to any surgery.

Practical Advice

• Administration: Take Imipramine exactly as prescribed by your doctor. It may be taken with or without food; taking it with food may reduce stomach upset. If you take it once daily, take it at bedtime to minimise daytime drowsiness and to help with sleep. Swallow the tablets whole with a full glass of water; do not crush or chew.
• Monitoring: Regular follow‑up with your doctor is essential. This will include monitoring of your clinical response, particularly during the first few weeks of treatment and after dose changes. A baseline electrocardiogram (ECG) is recommended in patients with cardiac risk factors, at higher doses, or when QT‑prolonging drugs are co‑prescribed. Therapeutic drug monitoring (target range 150‑300 ng/mL for imipramine plus desipramine) is recommended for suspected toxicity, non‑adherence, or poor response. Liver function tests, complete blood counts, and serum electrolytes should be monitored periodically. In children treated for enuresis, periodic drug‑free intervals should be instituted.
• Storage: Store at room temperature (15‑30 °C) in a tightly closed container, protected from light and moisture. Keep out of the reach and sight of children. Because of the risk of fatal overdose in children, imipramine must be stored with extreme care, preferably in a locked cabinet.
• Lifestyle: Rise slowly from a sitting or lying position to reduce the risk of dizziness or fainting due to orthostatic hypotension. To minimise dry mouth, sip water frequently, suck on sugarless hard candy or ice chips, chew sugarless gum, or use a saliva substitute. Maintain adequate dietary fibre and fluid intake to prevent constipation. Avoid prolonged sun exposure and use sunscreen, as imipramine can increase sensitivity to sunlight. Maintain a regular sleep schedule and practise good sleep hygiene. Avoid alcohol and recreational drugs.
• Missed dose: If you miss a dose, take it as soon as you remember on the same day. If it is close to the time of your next dose, skip the missed dose and resume your regular schedule. Do not double the dose to make up for a missed one.
• Medical emergencies: Seek immediate medical attention if you experience signs of serotonin syndrome (agitation, confusion, rapid heart rate, high fever, muscle rigidity, seizures), symptoms of a serious allergic reaction (rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing), signs of a cardiac arrhythmia (palpitations, fainting, severe dizziness), or signs of neuroleptic malignant syndrome (high fever, severe muscle stiffness, confusion). An overdose of imipramine is a life‑threatening emergency; call 911 or your local emergency number immediately if an overdose is suspected, particularly in a child.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Selective serotonin reuptake inhibitors (SSRIs): Sertraline (Zoloft), escitalopram (Cipralex), fluoxetine (Prozac), paroxetine (Paxil), and citalopram (Celexa) are first‑line antidepressants for major depressive disorder. They have a more favourable safety profile than TCAs, particularly in overdose, and fewer anticholinergic side effects. They are generally preferred over imipramine as initial therapy.
• Serotonin‑norepinephrine reuptake inhibitors (SNRIs): Venlafaxine (Effexor), duloxetine (Cymbalta), and desvenlafaxine (Pristiq) are first‑line antidepressants that also target both serotonin and norepinephrine. They lack the anticholinergic and antihistaminergic side effects of imipramine.
• Other tricyclic antidepressants (TCAs): Amitriptyline (Elavil) is structurally related to imipramine and is also highly sedating; it is often preferred for its more extensive evidence base in neuropathic pain. Nortriptyline (Aventyl) is the secondary amine metabolite of amitriptyline with fewer anticholinergic effects and less sedation, which may be better tolerated by elderly patients. Clomipramine (Anafranil) has a strong serotonergic profile and is first‑line for obsessive‑compulsive disorder. Desipramine (Norpramin) is the active metabolite of imipramine with a predominantly noradrenergic profile.
• Atypical antidepressants: Mirtazapine (Remeron) provides sedation and appetite stimulation, but with a different receptor‑binding profile and lower cardiotoxicity in overdose. Bupropion (Wellbutrin) is an activating antidepressant with a low incidence of sexual dysfunction and weight gain. Vortioxetine (Trintellix) is a multimodal antidepressant with a unique receptor profile.
• For enuresis (paediatric): Desmopressin (DDAVP) is a first‑line pharmacotherapy for nocturnal enuresis with a more favourable safety profile than imipramine. Behavioural interventions, such as enuresis alarms, are first‑line non‑pharmacological approaches.
• Non‑pharmacological approaches: Cognitive behavioural therapy (CBT), interpersonal therapy (IPT), and behavioural activation are evidence‑based psychotherapies for depression. Exercise, mindfulness‑based stress reduction, and good sleep hygiene are important complementary measures.

Clinical Efficacy

Imipramine is the original tricyclic antidepressant and has been a cornerstone of pharmacological depression treatment since its introduction in the late 1950s. A comprehensive body of clinical evidence, including numerous randomised controlled trials and meta‑analyses, has established its efficacy in the treatment of major depressive disorder. In a systematic review and meta‑analysis of dose‑response relationships for TCAs, 300 mg of imipramine/desipramine was found to be statistically significantly superior to 150 mg in the treatment of acute depression, supporting the existence of a clinically meaningful dose‑response relationship.

Imipramine has been shown to be as effective as other TCAs and, in many studies, comparable to newer antidepressants, although its side‑effect profile makes it less favourable as a first‑line agent for most patients. In a meta‑analysis of over 45,000 patients, imipramine demonstrated significantly lower comparative variance in response compared with several other antidepressants, indicating a relatively consistent treatment effect. Studies have also demonstrated imipramine's effectiveness for panic disorder, where it has been shown to block panic attacks with an efficacy comparable to that of selective serotonin reuptake inhibitors and benzodiazepines. For nocturnal enuresis, imipramine has demonstrated temporary efficacy in reducing bed‑wetting episodes, although the relapse rate upon discontinuation is high and a periodic drug‑free interval is recommended.

The drug is well‑known for its broad pharmacological effects, and therapeutic drug monitoring is recommended to optimise treatment, with a target reference range of 150 to 300 ng/mL for the combined plasma concentration of imipramine and desipramine. Imipramine has a narrower therapeutic index than modern antidepressants, and its cardiotoxicity in overdose, including the potential for fatal arrhythmias, limits its use in patients at risk of self‑harm. The Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines continue to list TCAs, including imipramine, as a second‑ or third‑line option for major depressive disorder, typically reserved for patients who have failed to respond to first‑line agents such as SSRIs and SNRIs.

Important:

Imipramine is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It carries a boxed warning for an increased risk of suicidal thinking and behaviour in children, adolescents, and young adults under the age of 25 during the first few months of treatment. All patients, regardless of age, should be closely monitored for clinical worsening, suicidality, or unusual changes in behaviour, particularly when starting therapy or after dosage changes. This medication can cause significant drowsiness and may impair the mental alertness and physical coordination required for driving or operating dangerous machinery. Alcohol must be strictly avoided, as it can potentiate the sedative effects of imipramine and increase the risk of severe respiratory depression. Imipramine is toxic in overdose, and even a small overdose can be fatal, especially in children; the medication must be stored securely out of the reach of children. Do not discontinue Imipramine abruptly; a gradual taper is required to minimise the risk of withdrawal symptoms. Imipramine is contraindicated with MAOIs, and a 14‑day washout period must be observed. If you experience symptoms of serotonin syndrome (agitation, confusion, rapid heart rate, high fever, muscle rigidity), a serious allergic reaction (rash, swelling of the face or throat, difficulty breathing), or cardiac symptoms (palpitations, fainting, severe dizziness), seek emergency medical attention immediately. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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