Tofranil (imipramine hydrochloride) is a tricyclic antidepressant (TCA) with a well-established clinical profile for the management of major depressive disorder. Its mechanism of action involves potent inhibition of norepinephrine and serotonin reuptake, facilitating enhanced neurotransmission in key brain regions responsible for mood regulation. With decades of rigorous clinical use and evidence-based support, Tofranil remains a cornerstone in psychopharmacology for patients requiring robust, sustained antidepressant therapy. This agent is also approved for the treatment of nocturnal enuresis in children, underscoring its versatility within medical practice.

Features

• Active ingredient: Imipramine hydrochloride
• Drug class: Tricyclic antidepressant (TCA)
• Available formulations: 10 mg, 25 mg, and 50 mg oral tablets
• Prescription status: Rx-only, requiring medical supervision
• Half-life: Approximately 8–16 hours, supporting once- or twice-daily dosing
• Metabolism: Hepatic, primarily via CYP2D6 and CYP2C19 isoenzymes

Benefits

• Achieves significant improvement in core depressive symptoms such as low mood, anhedonia, and fatigue
• Provides sustained mood stabilization with a well-characterized long-term efficacy and safety profile
• Reduces frequency of nocturnal enuresis episodes in pediatric patients aged 6 years and older
• Offers a cost-effective treatment option within the TCA drug class
• May alleviate certain comorbid anxiety symptoms associated with depression
• Supports restoration of normal sleep architecture and appetite regulation in depressed individuals

Common use

Tofranil is primarily indicated for the treatment of major depressive disorder in adults. It is used both in acute-phase treatment and maintenance therapy to prevent relapse. Off-label, it may be employed in the management of panic disorder, neuropathic pain, and migraine prophylaxis, though such use should be guided by specialist assessment. In pediatric populations, it is specifically approved for the treatment of nocturnal enuresis in children aged 6 years and older after organic causes have been ruled out.

Dosage and direction

Dosage must be individualized based on clinical response and tolerability. For depression in adults: initial dose is 75 mg daily, divided or as a single bedtime dose. This may be gradually increased to 150–200 mg daily, with a maximum dose of 300 mg/day for inpatients. For elderly patients: initiate at 30–40 mg daily in divided doses, not exceeding 100 mg daily. For pediatric enuresis (age 6+): begin with 25 mg one hour before bedtime; may increase to 50 mg nightly if needed. Tablets should be swallowed whole with water, with or without food.

Precautions

Use with caution in patients with cardiovascular disease, history of seizures, glaucoma, urinary retention, or hyperthyroidism. Periodic monitoring of blood pressure, heart rate, and ECG is advised, especially in elderly patients. May impair mental or physical abilities required for driving or operating machinery. Avoid abrupt discontinuation to prevent withdrawal symptoms. Pregnancy Category C: use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding.

Contraindications

Hypersensitivity to imipramine or other TCAs; concomitant use with MAOIs or within 14 days of discontinuing MAOI therapy; acute recovery phase after myocardial infarction; severe liver impairment.

Possible side effect

Common: dry mouth, blurred vision, constipation, dizziness, drowsiness, orthostatic hypotension, weight gain. Less common: tachycardia, urinary retention, sweating, confusion, agitation. Rare: seizures, blood dyscrasias, hepatotoxicity, neuroleptic malignant syndrome. Side effects are often dose-dependent and may diminish with continued use.

Drug interaction

Contraindicated with MAOIs. Use with caution with SSRIs, antipsychotics, anticonvulsants, antihypertensives, and other CNS depressants. Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase imipramine levels. May potentiate effects of alcohol, sedatives, and sympathomimetics.

Missed dose

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to catch up. Maintain regular dosing schedule to ensure stable plasma concentrations.

Overdose

Symptoms may include severe drowsiness, agitation, confusion, tachycardia, hypotension, convulsions, coma, and cardiac arrhythmias. Management is supportive and symptomatic; gastric lavage and activated charcoal may be considered. ECG monitoring is essential. There is no specific antidote.

Storage

Store at room temperature (15–30°C) in a dry place, protected from light. Keep in original container, tightly closed. Do not use after expiration date. Keep out of reach of children and pets.

Disclaimer

This information is for educational purposes and does not replace professional medical advice. Always consult a qualified healthcare provider for diagnosis, treatment decisions, and personalized dosage recommendations. Do not initiate or discontinue therapy without medical supervision.

Reviews

“Tofranil has been a reliable option in my practice for treatment-resistant depression. Its effect is robust, though anticholinergic side effects require careful management.” – Dr. Elena Rostova, Psychiatrist
“After trying several newer antidepressants, my physician prescribed Tofranil. It took several weeks, but the improvement in my mood and energy has been significant.” – Patient, 42
“Used for my son’s enuresis under medical guidance. Effective, though we noticed some morning drowsiness initially.” – Parent of patient, age 8