Amitriptyline (Amitriptyline hydrochloride)
Also sold as: Tryptomer, Elavil, Amitril, Saroten, Tryptanol
Pregnancy
Cat C
Lactation
Caution
Schedule
H
Forms
Tablets 10mg, 25mg, 50mg, 75mg +1
Indications
- Major depressive disorder (especially with melancholic features or insomnia)
- Neuropathic pain (diabetic neuropathy, post-herpetic neuralgia)
- Migraine prophylaxis
- Fibromyalgia
- Chronic tension-type headache prophylaxis
- Nocturnal enuresis in children (bedwetting)
- Irritable bowel syndrome (low dose)
- Insomnia (low dose)
Adult Dosing
Depression
25–75mg at night
Start 25mg at night; increase by 25mg every 1–2 weeks to 75–150mg/night
Give as single bedtime dose to use sedation therapeutically and reduce daytime side effects. Maximum 150–300mg/day in hospital settings.
Neuropathic pain
10–25mg at night
Start 10mg; increase slowly to 25–75mg. Often effective at sub-antidepressant doses.
First-line recommended (NICE, NeuPSIG guidelines) for neuropathic pain
Migraine prophylaxis
10–25mg at night
Increase slowly to 75mg/night as tolerated; reassess after 2–3 months
Fibromyalgia
10–25mg at night
10mg starting; titrate to 25–50mg
Insomnia (off-label)
10–25mg
1–2 hours before bed
Pediatric Dosing
NOT recommended for paediatric depression (increased suicidality). Use for nocturnal enuresis only under specialist guidance. Duration limited; reassess need periodically.
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| Mild-moderate renal impairment | No specific dose adjustment; use with caution |
| Severe renal impairment | Reduce dose; risk of accumulation of active metabolites |
Hepatic Adjustment
Use with caution in hepatic impairment; reduce dose. May precipitate hepatic encephalopathy. Avoid in severe hepatic disease.
Pregnancy & Lactation
Pregnancy: Category C
Neonatal withdrawal syndrome and respiratory depression reported. Anticholinergic effects may affect fetal heart rate. Use only if clearly indicated. Avoid near delivery if possible.
Lactation: Caution
Excreted in breast milk; relatively low neonatal exposure. Sedation in nursing infants reported. Monitor infant. Generally considered compatible with breastfeeding at low doses.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| MAO Inhibitors (phenelzine, tranylcypromine, selegiline) | FATAL combination — severe serotonin syndrome, hyperpyrexia, seizures, cardiovascular collapse. Absolutely contraindicated. 14-day washout required. | Major |
| Anticholinergic agents (antihistamines, antipsychotics, oxybutynin, ipratropium) | Additive anticholinergic toxicity: urinary retention, paralytic ileus, toxic confusional state, hyperthermia | Major |
| CNS depressants (benzodiazepines, opioids, alcohol, antihistamines) | Additive CNS and respiratory depression; increased sedation, psychomotor impairment | Moderate |
| CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion) | Markedly increase amitriptyline blood levels by inhibiting CYP2D6-mediated metabolism — risk of TCA toxicity (arrhythmia, anticholinergic crisis) | Major |
| Antihypertensives (clonidine, methyldopa, guanethidine) | TCAs block neuronal reuptake of antihypertensives, antagonising their blood pressure lowering effect; paradoxical hypertension may occur | Moderate |
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Side Effects
Common
- Dry mouth (most common)
- Sedation and drowsiness
- Constipation
- Blurred vision
- Urinary retention (especially in men with prostatic hypertrophy)
- Dizziness and orthostatic hypotension
- Weight gain
- Tachycardia
Serious / Discontinue If
- Cardiotoxicity: QT prolongation, bundle branch block, ventricular arrhythmia — DANGEROUS in overdose
- TCA OVERDOSE: life-threatening — widened QRS, ventricular fibrillation, hypotension, coma, seizures. Narrow therapeutic index.
- Seizures (lowers seizure threshold)
- Serotonin syndrome with MAOIs
- Paralytic ileus and urinary retention (from anticholinergic effects)
- Manic switch in bipolar disorder
Contraindications
- Concurrent use with or within 14 days of MAO inhibitors
- Recent myocardial infarction (within 3 months)
- Cardiac arrhythmias, bundle branch block, or QT prolongation
- Severe hepatic impairment
- Closed-angle glaucoma
- Urinary retention / bladder neck obstruction
- Hypersensitivity to amitriptyline or other tricyclic antidepressants
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Tryptomer 10 | Merck India Ltd. | 10 tab ₹22 |
| Tryptomer 25 | Merck India Ltd. | 10 tab ₹32 |
| Amitril 25 | Cipla Ltd. | 10 tab ₹28 |
| Saroten 25 | Lundbeck India (H. Lundbeck A/S) | 10 tab ₹48 |
| Elavil 25 | USV Ltd. | 10 tab ₹35 |
Monitoring Required
- ECG — baseline and periodically; assess QTc and QRS duration
- Cardiac monitoring in elderly and in patients with cardiovascular disease
- Suicidal ideation — especially early in treatment and in <24 age group
- Anticholinergic effects — urinary stream, bowel habit, eye symptoms
- Blood pressure — particularly orthostatic hypotension (fall risk in elderly)
- Weight — monthly in long-term therapy
- Blood glucose in diabetics (TCAs may cause hyperglycaemia)
Patient Counseling Points
- Take at bedtime — sedation is a side effect but also helps with sleep
- OVERDOSE DANGER: This medicine is dangerous in overdose. Keep out of reach of children. If you are having suicidal thoughts, tell your doctor immediately.
- Never take with or within 14 days of MAO inhibitor medicines
- Dry mouth, constipation, and blurred vision are common — drink water, eat fibre, and blink exercises may help
- Avoid alcohol completely — severe CNS depression possible
- Do not drive or operate heavy machinery until you know how this medicine affects you (significant sedation)
- Rise slowly from sitting or lying — dizziness on standing (orthostatic hypotension) can cause falls
- Effects on pain or depression may take 2–4 weeks — do not stop without consulting doctor
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Clinically reviewed by: Dr. Vijaya Lakshmi, MD DPM Psychiatry, MBBS — Sri Ramachandra University Chennai
Last reviewed: 2026-04-01
References
- Indian National Formulary (INF) 2023 — Amitriptyline monograph
- CDSCO Prescribing Information — Amitriptyline hydrochloride
- Goodman & Gilman's Pharmacological Basis of Therapeutics, 13th ed., Chapter 15
- NICE CG96 — Neuropathic pain in adults: pharmacological management 2023
- NeuPSIG Guidelines — Neuropathic pain pharmacotherapy 2022
- Scottish Intercollegiate Guidelines Network (SIGN) 127 — Chronic pain management
- British National Formulary (BNF) 85 — Amitriptyline hydrochloride