Tofranil (Imipramine) – Patient Information for Australia
Basic Product Information
| International Non-Proprietary Name (INN) | Imipramine |
|---|---|
| Australia Brand Name(s) | Tofranil, Tofranil-PM |
| ATC Code | N06AA02 |
| Available Forms / Strengths | Tablets: 10 mg, 25 mg, 50 mg; Sustained-release (SR) tablets: 75 mg |
| Manufacturers | Alphapharm, Mylan, Sandoz, and others |
| Prescription Status (Australia) | Prescription Only (Schedule 4: S4) |
Mechanism of Action
- In simple terms for patients: Tofranil (imipramine) helps improve mood and reduce anxiety by increasing levels of certain natural substances (neurotransmitters, such as serotonin and noradrenaline) in the brain. This makes it easier for people struggling with depression, anxiety, or bed-wetting to feel and function better.
- For health professionals: Imipramine is a tricyclic antidepressant (TCA). It works by inhibiting the reuptake of serotonin and norepinephrine at presynaptic nerve endings in the CNS, thus enhancing serotonergic and noradrenergic neurotransmission. Imipramine also has mild anticholinergic, antihistaminic, and sedative properties, which account for some of its side effect profile and clinical indications.
Pharmacokinetics
- Absorption: Rapid and almost complete absorption from the gastrointestinal tract. Peak plasma levels reached within 1–2 hours after oral intake.
- Metabolism: Extensively metabolised in the liver, mainly via CYP2D6 to desipramine (active metabolite).
- Elimination: Excreted primarily in urine (80%) as inactive metabolites. Minor faecal excretion.
- Duration of Action: Half-life 11–25 hours (imipramine); 12–32 hours (desipramine).
Use in Everyday Life and Best Practices
Tofranil is most commonly prescribed for depression (particularly where sedative action is desirable), anxiety disorders, and nocturnal enuresis (bed-wetting) in children. Tofranil should always be taken exactly as prescribed by your doctor. Do not adjust your dose unless instructed by your healthcare professional.
- Typical adult depression/anxiety dose: 75–150 mg daily in divided doses or as a single dose at night. May be increased up to 200 mg or more in severe cases. Maximum adult dose usually does not exceed 300 mg per day.
- Nocturnal enuresis (bed-wetting in children): Dose is lower and age-dependent (see dosing table below).
- Tablet should be swallowed whole with Water.
- Regular administration at the same time each day improves effectiveness and reduces risk of missed doses.
- Do not stop suddenly. If you wish to stop, consult your doctor for a gradual dose reduction plan.
Dosing: Morning vs Evening
- Advantages of evening dosing:
- May reduce drowsiness or sedative side effects felt during the day, especially at treatment initiation.
- Often preferred in patients with sleep difficulties.
- Advantages of morning dosing:
- Suitable for those at risk of “morning hangover” (residual drowsiness from night dose).
- May reduce the risk of insomnia (rare).
- Key tip: Consistency is crucial; take it at the same time every day.
- Your doctor may adjust timing to minimise side effects and optimise benefits.
Taking with Food or on an Empty Stomach
- May be taken with or without food. Food does not substantially affect absorption.
- If you experience stomach upset, try taking Tofranil with meals or a light snack.
- No specific dietary restrictions for typical English or Australian diets are required. Avoid large amounts of grapefruit juice as it may interact with metabolism.
- Drink enough water and maintain a balanced diet for overall health.
Interaction Warnings
| Interaction | Possible Effect | Advice |
|---|---|---|
| Alcohol | Increased sedation, risk of impaired coordination | Avoid or limit alcohol intake |
| Other antidepressants (SSRIs, MAOIs, SNRIs) | Risk of serotonin syndrome or toxic reactions | Do not combine unless under specialist supervision |
| Anticholinergic medications (e.g., some antihistamines, bladder medicines) | Increased risk of dry mouth, constipation, blurred vision, confusion | Consult your doctor or pharmacist |
| Antihypertensives (e.g., clonidine, guanethidine) | May reduce blood pressure-lowering effect | Monitor blood pressure; discuss alternatives |
| Cimetidine (stomach acid reducer) | Increased imipramine blood levels, risk of side effects | Monitor closely if prescribed together |
| Grapefruit juice | Possible effect on metabolism | Best avoided in large amounts |
Indications
| Indication | Official (TGA Approved) | Off-Label / Specialist Use |
|---|---|---|
| Major depressive disorder | ✔ | |
| Panic disorder | ✔ | |
| Nocturnal enuresis (children over 6) | ✔ | |
| Chronic pain, neuropathic pain | ✔ | |
| Obsessive-compulsive disorder (OCD) | ✔ | |
| ADHD, social anxiety disorder, PTSD | ✔ (specialist only) |
Dosing According to Clinical Indication
| Indication | Age Group | Typical Starting Dose | Usual Range | Maximum Dose |
|---|---|---|---|---|
| Depression | Adults | 25–50 mg at night or in divided doses | 75–150 mg/day | 300 mg/day |
| Panic Disorder | Adults | 10–25 mg at night | 50–150 mg/day | 300 mg/day |
| Nocturnal Enuresis | Children 6–8 years | 10–20 mg at night | 10–20 mg at night | 20 mg/night |
| Nocturnal Enuresis | Children 9–12 years | 25–35 mg at night | 25–35 mg at night | 35 mg/night |
| Nocturnal Enuresis | Adolescents 13–18 years | Up to 50 mg at night | Up to 50 mg at night | 50 mg/night |
| Depression | Elderly (65+) | 10–25 mg at night | 25–75 mg/day | 100 mg/day |
Dosing may be adjusted by your doctor according to individual response and tolerance. Never change your dose without consulting your healthcare professional.
Safety Profile and Side Effects
- Most side effects are mild and temporary. Some may require medical attention, especially in the elderly or those with underlying health conditions.
| Common Side Effects | Rare but Serious Side Effects |
|---|---|
|
|
- Seek urgent medical help if you experience chest pain, severe dizziness, confusion, fainting, or signs of allergic response.
Guidelines for Proper Use (Australia)
- Take exactly as prescribed – never share with others.
- If you miss a dose, take it as soon as you remember. If it’s nearly time for your next dose, skip the missed dose. Do not double up.
- Inform your GP or pharmacist about all other medicines and supplements you use, including non-prescription and herbal products.
- Let your doctor know if you become pregnant or plan to breastfeed while on imipramine.
- Keep out of reach of children and store below 25°C, away from direct sunlight and moisture.
- Plan safe transport: Do not drive or operate complex machinery until you know how Tofranil affects you.
- Attend regular follow-up appointments and report any new or worrying symptoms.
Alternative Treatment Options
- Other antidepressants (PBS-reimbursed in Australia):
- SSRIs: Sertraline, fluoxetine, escitalopram (fewer side effects, often first-line for depression/anxiety)
- SNRIs: Venlafaxine, duloxetine (may help if pain is also present)
- Noradrenaline reuptake inhibitors: Reboxetine
- Other TCAs: Amitriptyline, nortriptyline (similar efficacy/side effects)
- Agomelatine, mirtazapine: Different mechanisms – may be useful if side effects from TCAs or SSRIs are problematic
- For nocturnal enuresis:
- Desmopressin (hormonal, lower risk of side effects)
- Enuresis alarms (behavioural therapy)
- Other TCAs (off-label)
Therapy is always tailored by your prescriber according to personal needs, response, side effect risk, and cost/accessibility.
Legal, Registration, and Reimbursement Status in Australia
- TGA (Therapeutic Goods Administration) approved medicine.
- Prescription only (Schedule 4/S4).
- Covered as a subsidised item under the Pharmaceutical Benefits Scheme (PBS) for depression and certain other conditions.
- Regular review and reporting required if prescribed long-term, especially for children and elderly patients.
Latest Research & Clinical Guidance (2022–2025)
- 2022–2025 guidelines from the RACGP and TGA recommend TCAs such as imipramine primarily for patients who do not respond to newer antidepressants (e.g., SSRIs, SNRIs) due to higher side effect burden.
- Recent meta-analyses (NICE CG90) confirm comparable efficacy to other antidepressants but highlight the need to monitor cardiac and anticholinergic side effects, especially in older adults.
- Emerging evidence supports some off-label uses (e.g., neuropathic pain, treatment-resistant anxiety), but always requires specialist supervision.
- Long-term use in enuresis is discouraged in favour of behavioural therapy or desmopressin where possible (Royal Children’s Hospital Melbourne guidance).
Availability and Delivery
| Pack Size | Tablets per Pack | Typical PBS Price (AUD) | Popular Delivery Times* |
|---|---|---|---|
| 10 mg Tablets | 50 / 100 | $8.80–$12.00 | Sydney: 1–2 days; Melbourne: 1–2 days; Brisbane: 2–3 days; Perth: 3–4 days; Adelaide: 2 days |
| 25 mg Tablets | 50 / 100 | $9.30–$13.00 | See above |
| 50 mg Tablets | 50 / 100 | $12.70–$17.50 | See above |
| 75 mg SR Tablets | 30 | $15.30–$19.00 | See above |
*Indicative delivery times for Registered/S4 medicines from well-known pharmacy chains and online pharmacies. Rural/remote deliveries may take 1–2 days longer.
Frequently Asked Questions (FAQ)
- How long does Tofranil take to work for depression?
Most patients notice some improvement in mood after 2–3 weeks. Maximum benefit can take up to 4–6 weeks. Continue taking as prescribed and discuss any concerns with your doctor. - Can I drink alcohol while using Tofranil?
Alcohol can increase sedation and risk of side effects. It’s best to avoid or limit alcohol while on this medication. - Is it safe to stop taking Tofranil suddenly?
No. Always consult your doctor before stopping. Abrupt discontinuation may result in withdrawal symptoms (e.g., nausea, headache, irritability, sleep difficulties). - Is Tofranil addictive?
Tofranil is not addictive, but sudden withdrawal can cause symptoms. Take exactly as prescribed and work with your healthcare team for any planned changes. - Does this medicine affect contraception or pregnancy?
Speak to your doctor if you are pregnant, planning pregnancy, or breastfeeding. Tofranil may not be the first choice in these situations, but your doctor will discuss possible risks and alternatives.
If you have further questions or need detailed advice about Tofranil (imipramine), please contact your local pharmacist or GP. For information about safe medicine use throughout Australia, visit the NPS MedicineWise website.
