Generic Trazodone ( Trazodone hydrochloride )

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Trazodone is an antidepressant that belongs to the serotonin antagonist and reuptake inhibitor (SARI) class. It is used primarily for the treatment of major depressive disorder, and at lower doses it is widely prescribed off‑label for the management of insomnia because of its strong sleep‑promoting properties. Trazodone works by inhibiting the reuptake of serotonin and blocking serotonin 5‑HT_2A receptors, which together enhance serotonergic activity in the brain, helping to relieve depression and anxiety while also promoting restful sleep.

Usual adult dose: For depression, treatment is typically started at 150 mg per day, divided into two or three doses, and taken after meals. The dose may be gradually increased by 50 mg every 3 to 4 days until an optimal response is achieved, with a usual effective range of 300 mg to 400 mg daily; the maximum recommended dose is 600 mg per day in divided doses. For insomnia (off‑label), a lower single dose of 25 mg to 100 mg is taken at bedtime, with many patients finding that 25 mg or 50 mg is sufficient to improve sleep without excessive next‑day drowsiness.

Dosage form: Tablets are available in 25 mg, 50 mg, and 100 mg strengths. Tablets may be scored to allow for flexible dosing.

Onset of action: For depression, an initial improvement in mood, energy, or anxiety may be seen within 1 to 2 weeks, but the full antidepressant effect typically requires 4 to 6 weeks of continuous therapy. When used for insomnia, the sedative effect is usually felt within 30 minutes to 2 hours after taking a dose at bedtime.

Duration of action: The elimination half‑life of trazodone is approximately 5 to 9 hours, and its active metabolite, m‑chlorophenylpiperazine (mCPP), has a longer half‑life. The sleep‑promoting effect generally lasts through the night, while antidepressant efficacy is maintained with divided daily dosing.

Alcohol recommendation: Alcohol consumption should be avoided during treatment with Trazodone. Alcohol can increase the sedative effects of the medication, leading to excessive drowsiness, dizziness, and impaired coordination, and may also worsen depression and anxiety.

Most common side effects: Drowsiness, dizziness, dry mouth, headache, nausea, and constipation. Weight changes (gain or loss) and blurred vision may also occur. A rare but serious side effect is priapism (a prolonged, painful erection), which requires immediate emergency medical attention.

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General Information about Trazodone (Trazodone hydrochloride)

• INN (International Nonproprietary Name): Trazodone hydrochloride
• Brand names available in Canada: The original brand name Desyrel® (Bristol‑Myers Squibb) is no longer actively marketed in Canada, but generic versions are widely available. These include APO‑Trazodone (Apotex Inc.), TEVA‑Trazodone (Teva Canada Limited), Sandoz Trazodone (Sandoz Canada Inc.), PMS‑Trazodone (Pharmascience Inc.), JAMP‑Trazodone (JAMP Pharma Corporation), M‑Trazodone (Mantra Pharma Inc.), and other manufacturer‑branded generics.
• ATC code: N06AX05
• Dosage forms and strengths: Tablets: 25 mg, 50 mg, and 100 mg. The 150 mg and 300 mg tablets are also available in Canada but are typically used for the treatment of depression. The 25 mg, 50 mg, and 100 mg strengths are often preferred for insomnia dosing.
• Manufacturers in Canada: Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Pharmascience Inc., JAMP Pharma Corporation, Mantra Pharma Inc., and other generic pharmaceutical companies.
• Registration status in Canada: Approved by Health Canada. Marketed.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act.

Mechanism of Action and Pharmacology

Trazodone is a triazolopyridine derivative with a unique pharmacological profile. It acts as a serotonin (5‑HT) antagonist and reuptake inhibitor (SARI). Specifically, it is a potent inhibitor of the serotonin transporter (SERT), which increases the synaptic availability of serotonin. At the same time, it is a strong antagonist at serotonin 5‑HT_2A and 5‑HT_2C receptors. This dual action is believed to enhance serotonin signalling via 5‑HT_1A receptors while blocking the receptors that contribute to agitation, anxiety, and sexual dysfunction. The blockade of 5‑HT_2A and histamine H₁ receptors also gives trazodone its pronounced sedative properties, which are particularly evident at lower doses. Trazodone has minimal affinity for muscarinic cholinergic receptors, which reduces the risk of anticholinergic side effects like dry mouth, constipation, and blurred vision compared with older tricyclic antidepressants.

After oral administration, trazodone is well absorbed. Peak plasma concentrations are reached within 1 to 2 hours. The drug is extensively metabolized in the liver, primarily by cytochrome P450 3A4, to its major active metabolite, m‑chlorophenylpiperazine (mCPP). The elimination half‑life of trazodone is 5 to 9 hours, while mCPP has a longer half‑life of 4 to 14 hours. Steady‑state plasma levels are achieved within 3 to 7 days of regular dosing. Approximately 70–75% of a dose is excreted in the urine, mainly as metabolites. Food can increase the rate and extent of absorption, and taking the medication with or shortly after a meal may improve tolerability and reduce peak‑related side effects like dizziness.

Indications

• Major Depressive Disorder (MDD): For the acute and maintenance treatment of major depressive episodes in adults.
• Insomnia (Off‑label): Trazodone is widely prescribed off‑label at low doses (25 mg to 100 mg) for the management of insomnia, particularly when associated with depression or when a non‑habit‑forming alternative to benzodiazepines or Z‑drugs is desired.
• Generalized Anxiety Disorder (GAD) and other anxiety disorders (Off‑label): It may be used as an alternative or adjunctive treatment, especially when anxiety accompanies depression or when sedation is desirable.
• Not recommended for use in children and adolescents; safety and efficacy in paediatric populations have not been established.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: There are no adequate and well‑controlled studies in pregnant women. Trazodone should be used during pregnancy only if the potential benefit clearly outweighs the potential risk to the foetus. Neonates exposed late in the third trimester may develop withdrawal symptoms.
• Breastfeeding: Trazodone and its metabolites are excreted in breast milk. 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.
• Paediatrics: Safety and efficacy in children and adolescents have not been established. Trazodone is not recommended for use in individuals under 18 years of age.
• Elderly: Elderly patients are more sensitive to the sedative and hypotensive effects of trazodone. Lower initial doses (e.g., 25 mg to 50 mg daily) are recommended, with careful titration. Trazodone is included in the Beers Criteria of potentially inappropriate medications for older adults, primarily due to its anticholinergic and sedative effects, but it is still used with caution at low doses for insomnia.
• Hepatic impairment: Trazodone is extensively metabolized by the liver. Use with caution and start with lower doses in patients with hepatic impairment.
• Renal impairment: No significant dose adjustment is required, but caution is advised in severe renal impairment.
• Cardiovascular disease: Trazodone can cause orthostatic hypotension and, rarely, QT prolongation and cardiac arrhythmias. Use with caution in patients with pre‑existing heart disease, conduction abnormalities, or a history of myocardial infarction. An electrocardiogram (ECG) should be considered prior to initiating treatment in patients with cardiac risk factors.
• Bipolar disorder: Screen for bipolar disorder before starting treatment. Trazodone may precipitate a manic or hypomanic episode in patients with undiagnosed bipolar disorder.
• Suicidality: Antidepressants, including trazodone, may increase the 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 and unusual changes in behaviour.
• Priapism: Trazodone has been associated with the occurrence of priapism, a prolonged and painful erection that is a urological emergency. Cases have been reported at doses as low as 50 mg. Patients should be instructed to seek immediate medical attention if they develop an erection lasting longer than 4 hours.
• Serotonin syndrome: A potentially life‑threatening serotonin syndrome may occur with trazodone, particularly when combined with other serotonergic drugs. Symptoms include mental status changes, autonomic instability, neuromuscular abnormalities, and gastrointestinal upset. Immediate medical attention is required.
• Angle‑closure glaucoma: Trazodone can cause pupillary dilation, which may trigger an acute attack of angle‑closure glaucoma in susceptible individuals.
• Allergy: Do not take trazodone if you have a known hypersensitivity to trazodone hydrochloride or any excipient in the formulation.

Driving and alcohol

Trazodone can cause significant drowsiness, dizziness, and impaired concentration, especially at the start of therapy and after dose increases. Patients should not drive, operate heavy machinery, or engage in potentially dangerous activities until they know how the medication affects them. Alcohol must be strictly avoided during treatment, as it can intensify the sedative effects of trazodone, increasing the risk of profound drowsiness, respiratory depression, and motor vehicle accidents.

Dosage Instructions

• Major Depressive Disorder (Adults): The recommended initial dose is 150 mg per day, divided into two or three doses, taken after meals. The dose may be increased by 50 mg per day every 3 to 4 days as tolerated. The usual therapeutic dose range is 300 mg to 400 mg per day; the maximum recommended dose is 600 mg per day in divided doses. Once an adequate response has been achieved, the total daily dose may be given as a single evening dose, but the maximum single dose should not exceed 400 mg.
• Insomnia (Off‑label, Adults): The typical starting dose is 25 mg to 50 mg taken once daily at bedtime. The dose may be increased to 100 mg at bedtime if lower doses are insufficient and well tolerated. The 25 mg strength is particularly useful for the lowest effective dosing.
• Elderly or Debilitated Patients: For depression, start at 25 mg to 50 mg daily, given as a single evening dose or in divided doses, and increase slowly. For insomnia, start at 25 mg at bedtime.
• Administration: Trazodone tablets should be taken with food to enhance absorption and reduce the risk of dizziness and gastrointestinal upset. When used for insomnia, a single dose is taken within 30 minutes of bedtime. The tablets may be scored and can be broken along the score line to achieve half‑doses if needed.
• 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 resume the regular schedule. Do not double the dose.
• Discontinuation: Gradual dose tapering is recommended to avoid withdrawal symptoms such as anxiety, agitation, and sleep disturbance.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Drowsiness, dizziness, dry mouth, and headache.
• Common side effects (1‑10%): Nausea, vomiting, constipation, blurred vision, fatigue, weight gain or weight loss, hypotension, and confusion.
• Serious adverse reactions: Priapism (painful, prolonged erection), cardiac arrhythmias (including QT prolongation and torsades de pointes), orthostatic hypotension with syncope, serotonin syndrome, activation of mania or hypomania, and seizures. In rare cases, hyponatraemia and blood dyscrasias have been reported.
• Withdrawal symptoms: Abrupt discontinuation may cause anxiety, agitation, insomnia, and irritability. Gradual dose reduction is advised.
• Contraindications: Known hypersensitivity to trazodone hydrochloride or any component of the formulation. Concomitant use with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy. Treatment should not be initiated during the acute recovery phase of a myocardial infarction. Use with caution in patients with known QT prolongation.

Drug Interactions

• Monoamine oxidase inhibitors (MAOIs): Contraindicated. The combination can lead to serotonin syndrome. A 14‑day washout period is required.
• Serotonergic drugs: Concomitant use with SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, buspirone, St. John’s wort, and other serotonergic agents increases the risk of serotonin syndrome. Patients should be monitored closely.
• CNS depressants: Alcohol, benzodiazepines, opioids, and other sedating drugs will have additive sedative effects, increasing the risk of respiratory depression and psychomotor impairment.
• CYP3A4 inhibitors and inducers: Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) can increase trazodone plasma levels, necessitating a dose reduction. Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) can decrease trazodone levels, potentially reducing efficacy.
• Antihypertensives and diuretics: Trazodone may enhance the hypotensive effects of these agents, leading to orthostatic hypotension.
• Warfarin: There are reports of altered prothrombin time in patients taking trazodone and warfarin concurrently. INR monitoring is recommended.
• Digoxin: Trazodone may increase serum digoxin levels. Monitoring of digoxin levels is advised.
• QT‑prolonging drugs: Concomitant use with other drugs that prolong the QT interval (e.g., certain antiarrhythmics, fluoroquinolones, antipsychotics) may increase the risk of cardiac arrhythmias.

Practical Advice

• Administration: Take trazodone exactly as prescribed. For depression, divided doses after meals are recommended. For insomnia, take the dose at bedtime, preferably with a light snack, to help absorption and reduce nighttime waking. Swallow tablets whole with a glass of water, or break along the score line if a half‑tablet dose is required.
• Monitoring: Regular follow‑up visits are essential to assess therapeutic response, particularly during the first weeks of treatment. In patients with cardiac risk factors, an ECG may be obtained before starting and periodically during therapy. Monitor for signs of excessive sedation, orthostatic hypotension, and priapism. Patients should be alerted to the signs of serotonin syndrome and suicidal ideation.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep out of the reach and sight of children.
• Lifestyle: Rise slowly from a sitting or lying position to minimize the risk of dizziness. Maintain a regular sleep schedule and avoid the use of other sedating substances. Do not stop the medication abruptly; your doctor will help you taper the dose gradually when it is time to stop.
• Missed dose: If you miss a dose, take it as soon as remembered. If it is close to the time of your next dose, skip the missed dose. Do not double doses.
• When to seek medical attention: Seek immediate emergency medical help if you experience an erection lasting longer than 4 hours (priapism), as this can lead to permanent tissue damage. Other serious symptoms requiring urgent medical review include fainting, irregular heartbeat, severe allergic reaction (rash, swelling of the face or throat, difficulty breathing), confusion, hallucinations, or muscle stiffness with fever.
• 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

• Other antidepressants: SSRIs like sertraline (Zoloft) or escitalopram (Cipralex), SNRIs like venlafaxine (Effexor) or duloxetine (Cymbalta), and atypical agents like bupropion (Wellbutrin) are first‑line treatments for depression. They have different side‑effect profiles, and choice depends on individual patient factors and tolerability.
• Mirtazapine (Remeron): Like trazodone, mirtazapine is a sedating antidepressant that is often used when insomnia or poor appetite accompanies depression. It tends to cause significant weight gain.
• Agomelatine (Valdoxan): An antidepressant that improves sleep without daytime sedation, through its action on melatonin receptors. It is not associated with sexual dysfunction or weight gain.
• Non‑benzodiazepine hypnotics (Z‑drugs): Zopiclone (Imovane) and zolpidem (Sublinox) are indicated for the short‑term treatment of insomnia. They are effective but carry a risk of tolerance and dependence.
• Benzodiazepines: Lorazepam (Ativan), clonazepam (Rivotril), and others are effective for anxiety and insomnia but have a high potential for dependence and withdrawal.
• Non‑pharmacological approaches: Cognitive behavioural therapy for insomnia (CBT‑I) is a first‑line, evidence‑based treatment for chronic insomnia. Psychotherapy, such as cognitive behavioural therapy (CBT) and interpersonal therapy (IPT), is effective for depression and can be used alone or in combination with medication.

Clinical Efficacy

Trazodone has been shown to be effective in the treatment of major depressive disorder in numerous placebo‑controlled clinical trials. In a meta‑analysis of antidepressant trials, trazodone demonstrated a response rate of approximately 60%, comparable to that of SSRIs and tricyclic antidepressants. Its unique receptor profile gives it a particularly low incidence of sexual dysfunction, which is a significant advantage over many first‑line agents. For insomnia, while trazodone has not been formally approved for this indication, multiple observational studies and clinical practice reviews support its use as a safe and effective non‑controlled alternative to benzodiazepines. A 2022 systematic review found that low‑dose trazodone (50–100 mg) significantly improved sleep onset and maintenance, reduced the number of nighttime awakenings, and improved overall sleep quality compared with placebo, with fewer adverse events than classic hypnotics. Clinical guidelines from the Canadian Academy of Sleep Medicine recognize trazodone as an option for the management of chronic insomnia, especially when depression or anxiety co‑exists. The drug’s established safety profile, low risk of tolerance, and lack of significant potential for abuse make it a practical choice for long‑term insomnia management.

Important:

Trazodone is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It may increase the risk of suicidal thoughts and behaviour in children, adolescents, and young adults. All patients should be closely monitored for clinical worsening or unusual changes in behaviour. This medication can cause significant drowsiness and dizziness; do not drive or operate machinery until you know how it affects you. A rare but serious risk of priapism (a prolonged, painful erection) exists, which is a urological emergency that can lead to permanent damage if not treated immediately. If you develop an erection lasting longer than 4 hours, stop taking the medication and go to the nearest emergency department. Avoid alcohol, and do not take trazodone with MAOIs or other serotonergic drugs without your doctor’s advice. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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