IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
TRAZODONE – ORAL
COMMON BRAND NAME(S): Desyrel
WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.
Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.
USES: This medication is used to treat depression. Trazodone works by helping to restore the balance of a certain natural chemical (serotonin) in the brain.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug is used to help people with trouble sleeping (insomnia) to fall asleep. It is also used to help people with anxiety to relax.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using trazodone and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth, usually once or twice daily after a meal or snack or as directed by your doctor. If drowsiness is a problem and you are taking 1 dose daily, take it at bedtime. If you are taking 2 doses each day, it may help to take 1 of the doses at bedtime. Follow your doctor’s directions carefully.
Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose.
Take this medication exactly as prescribed. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.
It is important to continue taking this medication as prescribed even if you feel well. To help you remember, take it at the same time(s) each day. Do not stop taking this medication without consulting your doctor. Nausea, headache, or tiredness can occur if the drug is suddenly stopped.
It may take 2 to 4 weeks before you notice the full effects of this medication. Tell your doctor if your condition persists or worsens.
SIDE EFFECTS: See also the Warning section.
Nausea, vomiting, diarrhea, drowsiness, dizziness, tiredness, blurred vision, changes in weight, headache, muscle ache/pain, dry mouth, bad taste in the mouth, stuffy nose, constipation, or change in sexual interest/ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: shaking (tremors), nightmares, ringing in the ears, problems urinating, blood in urine.
Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), shortness of breath, stomach/abdominal pain.
Get medical help right away if any of these rare but serious side effects occur: chest/jaw/left arm pain, fainting, fast/irregular heartbeat, seizures, severe dizziness.
For males, in the very unlikely event you have a painful or prolonged erection (priapism) lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking trazodone, tell your doctor or pharmacist if you are allergic to it; or to nefazodone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of priapism from taking trazodone, recent heart attack.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar disorder, personal or family history of suicide attempts, heart disease (e.g., irregular heartbeat), liver disease, kidney disease, blood pressure problems.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Trazodone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using trazodone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using trazodone safely.
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness and dizziness.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
This drug should not be used with the following medications because very serious interactions may occur: sibutramine, triazolam.
If you are currently using any of the medications listed above, tell your doctor or pharmacist before starting trazodone.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other antidepressants (e.g., amitriptyline, bupropion, fluoxetine, nefazodone, venlafaxine), digoxin, drugs affecting liver enzymes that remove trazodone from your body (such as azole antifungals including ketoconazole/itraconazole, HIV protease inhibitor drugs including atazanavir/indinavir/ritonavir, macrolide antibiotics including erythromycin, cimetidine, rifamycins including rifampin, St. John’s wort, certain anti-seizure medications including carbamazepine), drugs for high blood pressure, ginkgo, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone).
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that may cause drowsiness. Ask your pharmacist about using those products safely.
Before you have surgery with a general anesthetic, including dental surgery, tell the doctor or dentist you are taking trazodone.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: painful/prolonged erection, slow/rapid/irregular heartbeat, unusual drowsiness, unusual dizziness, vomiting, trouble breathing, seizures.
NOTES: Do not share this medication with others.
Psychiatric and/or medical checkups (and laboratory tests) should be done periodically to monitor your progress and check for side effects. Consult your doctor for more details.
Have your blood pressure and pulse checked regularly while taking this medication. Discuss with your doctor how to monitor your own blood pressure and pulse.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store above 104 degrees F (40 degrees C). Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
Information last revised July 2010 Copyright(c) 2010 First DataBank, Inc.