Generic Trazodone ( Trazodone hydrochloride )

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Trazodone is an antidepressant used to treat major depressive disorder in adults. It is also widely prescribed off-label at lower doses for insomnia, especially in people who have trouble staying asleep. The medication works by increasing serotonin levels in the brain and blocking certain serotonin receptors, which helps improve mood and promote sleep.
The usual starting dose for depression is 150 mg per day in divided doses, taken shortly after a meal or light snack. Your doctor may increase the dose by 50 mg every three to four days, up to a maximum of 400 mg per day. For insomnia, doctors often prescribe much lower doses, typically 25 mg to 100 mg at bedtime.
The administration form is scored tablets in 25 mg, 50 mg, 100 mg, and 150 mg strengths. The tablets can be swallowed whole or broken in half along the score line, but they should not be chewed or crushed.
Trazodone does not work overnight. It may take several weeks of steady dosing before you notice the full benefit for depression. For sleep, the sedative effect is often felt within the first few doses.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that trazodone can cause, and it can increase the risk of low blood pressure and fainting.
The most common side effects are drowsiness, dizziness, dry mouth, headache, and fatigue. Some people also notice nausea, constipation, or blurred vision.
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Common Use Trazodone

Trazodone is a triazolopyridine antidepressant. It works by inhibiting the reuptake of serotonin at nerve endings and by blocking serotonin 5-HT2A receptors. This dual action helps restore chemical balance in the brain and is thought to underlie its antidepressant effect. The sedation that trazodone is known for comes mainly from its strong antagonism of alpha-1 adrenergic receptors and, to a lesser extent, histamine H1 receptors. Health Canada has approved trazodone for the relief of symptoms of depression in adults 18 years and older. It is not approved for use in children or adolescents. Because of its sedating properties, trazodone is commonly prescribed off-label for insomnia, particularly for people who have difficulty staying asleep. It is also sometimes used off-label for anxiety, panic disorder, and certain types of chronic pain, though these uses are not formally approved.

Basic Trazodone Information

• INN (International Nonproprietary Name): Trazodone hydrochloride
• Brand names available in Canada: Desyrel® (original brand, discontinued); generics include Apo-Trazodone (Apotex Inc.), Teva-Trazodone (Teva Canada Limited), PMS-Trazodone (Pharmascience Inc.), Mylan-Trazodone (Mylan Pharmaceuticals ULC), AG-Trazodone (Angita Pharma Inc.), Jamp Trazodone (Jamp Pharma Corporation), Sanis Trazodone (Sanis Health Inc.), Pro Doc Limitée (Trazodone-100), and others.
• ATC Code: N06AX05
• Forms and dosages: Scored tablets – 25 mg, 50 mg, 100 mg, and 150 mg. An extended-release tablet (Oleptro) is available in some markets but is not currently marketed in Canada.
• Manufacturers in Canada: Apotex Inc. (Apo-Trazodone, DIN 02147645 for 100 mg), Teva Canada Limited (Teva-Trazodone, DIN 02144271 for 100 mg), Pharmascience Inc. (PMS-Trazodone, DIN 01937227 for 50 mg, DIN 01937235 for 100 mg), Mylan Pharmaceuticals ULC (Mylan-Trazodone, DIN 02231684 for 100 mg), Angita Pharma Inc. (AG-Trazodone, DIN 02537923 for 150 mg), Jamp Pharma Corporation (Jamp Trazodone, DIN 02442825 for 150 mg), Sanis Health Inc. (Trazodone, DIN 02348772 for 50 mg), and Pro Doc Limitée (Trazodone-100, DIN 02348780 for 100 mg).
• Registration status in Canada: Approved by Health Canada. The original Desyrel brand is discontinued. Multiple generic trazodone products are marketed under various DINs, including 02147645 (Apo-Trazodone 100 mg), 02144271 (Teva-Trazodone 100 mg), 01937227 (PMS-Trazodone 50 mg), 01937235 (PMS-Trazodone 100 mg), 02231684 (Mylan-Trazodone 100 mg), 02537923 (AG-Trazodone 150 mg), 02442825 (Jamp Trazodone 150 mg), 02348772 (Sanis Trazodone 50 mg), and 02348780 (Trazodone-100).
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Trazodone exactly as your doctor prescribes. The dose depends on what is being treated. For depression in adults, the recommended starting dose is 150 mg per day, taken in divided doses after meals or a light snack. Your doctor may increase the dose by 50 mg per day every three to four days. The maximum recommended dose is 400 mg per day for outpatients and 600 mg per day for inpatients under close supervision. Once a satisfactory response is achieved, your doctor may gradually reduce the dose to the lowest effective maintenance level, often 150 mg to 300 mg per day. For insomnia, the dose is much lower, typically 25 mg to 100 mg taken at bedtime. Some doctors start at 25 mg and increase in 25 mg increments up to a maximum of 100 mg at bedtime if needed. Take the tablet shortly after a meal or light snack to improve absorption and reduce stomach upset. Swallow the tablet whole or break it in half along the score line. Do not chew or crush it. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once. Do not stop taking Trazodone suddenly without talking to your doctor. Stopping abruptly can cause withdrawal symptoms such as nausea, headache, and trouble sleeping. Your doctor will taper the dose gradually over weeks or months.

Precautions

Trazodone carries a boxed warning about an increased risk of suicidal thoughts and behaviours in pediatric and young adult patients taking antidepressants. Close monitoring is required, especially during the first few weeks of treatment or after dose changes. If you or someone you care for notices worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Trazodone can cause serotonin syndrome, a potentially life-threatening condition caused by too much serotonin in the body. The risk is higher when trazodone is taken with other serotonergic drugs, including MAO inhibitors, SSRIs, SNRIs, triptans, tramadol, and St. John's wort. Symptoms include agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Stop the medication and seek emergency care if these occur. Trazodone can cause orthostatic hypotension, a drop in blood pressure when standing up, leading to dizziness and fainting. This is more common in older adults and in people taking antihypertensive medications. Move slowly when getting up from a sitting or lying position. If you faint or feel dizzy, contact your doctor. Trazodone has been associated with priapism, a prolonged and painful erection that requires immediate medical attention. The risk appears to be highest within the first 28 days of treatment and at doses of 150 mg per day or less. If you experience an erection lasting more than 6 hours, stop the medication and seek emergency care right away. Trazodone can prolong the QT interval on an electrocardiogram, a change in heart rhythm that can lead to serious arrhythmias. Use with caution if you have heart disease or take other drugs that affect heart rhythm. Trazodone can increase the risk of bleeding, especially when taken with aspirin, NSAIDs, warfarin, or other anticoagulants. Tell your doctor if you take any of these medications. The medication can cause drowsiness and may impair your ability to drive or operate machinery. Do not drive or operate hazardous machinery until you know how Trazodone affects you. Trazodone should be used with caution in patients with a history of mania or bipolar disorder, as it can trigger a manic episode. Tell your doctor if you have a history of seizures. Trazodone is not recommended during pregnancy unless the benefit clearly outweighs the risk to the fetus. It passes into breast milk in small amounts, so breastfeeding is not recommended without medical advice. Women who could become pregnant should discuss the risks and benefits with their doctor. Trazodone has not been studied in children under 18 years of age and should not be used in that age group. Older adults may be more sensitive to the side effects of Trazodone, especially drowsiness and orthostatic hypotension, and may need lower doses. Tell your doctor if you have liver or kidney problems, as dose adjustments may be needed.

Contraindications

Do not take Trazodone if you have had an allergic reaction to trazodone or any of the inactive ingredients in the tablet. Trazodone is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including phenelzine, tranylcypromine, and moclobemide. Do not start an MAOI within 14 days of stopping Trazodone, and do not start Trazodone within 14 days of stopping an MAOI. This combination can cause a life-threatening condition called serotonin syndrome. Trazodone should not be used during the acute recovery phase following a heart attack. It is contraindicated in patients with known QT prolongation or in those taking other drugs that prolong the QT interval without close medical supervision. Do not take Trazodone if you have severe liver impairment. Trazodone should not be used during pregnancy or breastfeeding unless specifically directed by a doctor. The safety and effectiveness of Trazodone in children under 18 years of age have not been established. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

More than 5% of people experience drowsiness, dizziness, dry mouth, headache, and fatigue. Other common side effects include nausea, vomiting, constipation, diarrhea, blurred vision, and nasal congestion. Some people notice muscle pain, weight loss, or swelling of the hands and feet. These effects are often most noticeable when starting treatment or increasing the dose, and they may fade as your body adjusts. Serious side effects require immediate medical attention. Serotonin syndrome presents with agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Priapism, a prolonged and painful erection, is a medical emergency. Orthostatic hypotension can cause fainting. QT prolongation can cause palpitations, fainting, or sudden collapse. Increased bleeding risk can cause easy bruising or unusual bleeding. Severe allergic reactions, including rash, hives, swelling of the face or throat, and difficulty breathing, need emergency care. If you develop any of these serious effects, stop the medication and seek medical help right away. Antidepressants, including Trazodone, may increase suicidal thoughts or behaviour, especially in young people. If you notice worsening mood or new thoughts of self-harm, contact your doctor immediately. Discontinuation syndrome can occur if the medication is stopped suddenly, causing nausea, headache, and trouble sleeping.

Drug Interaction

Trazodone interacts with several medications. MAO inhibitors are strictly contraindicated and must not be used with Trazodone. Other serotonergic drugs, including other antidepressants (SSRIs, SNRIs, tricyclics), triptans, fentanyl, tramadol, and St. John's wort, can increase the risk of serotonin syndrome. Drugs that prolong the QT interval, such as certain antiarrhythmics, antipsychotics, and antibiotics, may increase the risk of dangerous heart rhythms when taken with Trazodone. Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, ritonavir, indinavir, and nefazodone, can increase trazodone levels and the risk of adverse reactions. If you take one of these, your doctor should start you on a lower dose of Trazodone. Strong CYP3A4 inducers, including carbamazepine, rifampin, phenytoin, and St. John's wort, can decrease trazodone levels and make it less effective. Drugs that affect bleeding, such as aspirin, NSAIDs, warfarin, and other anticoagulants, can increase the risk of bleeding when taken with Trazodone. Trazodone can add to the blood pressure-lowering effects of antihypertensive medications, potentially requiring a dose adjustment. Alcohol and other central nervous system depressants add to trazodone's sedative effects and should be avoided. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Trazodone, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can cause your symptoms to return, so try to take the medication at the same times each day.

Overdose

Overdose with Trazodone can cause severe drowsiness, dizziness, nausea, vomiting, and fast heart rate. In severe cases, it can cause serotonin syndrome, seizures, and changes in heart rhythm. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Trazodone tablets at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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