In the U.S.—

In Canada—

• Antidepressant
• Antineuralgic

Trazodone (TRAZ-oh-done) belongs to the group of medicines known as antidepressants or ``mood elevators.'' It is used to relieve mental depression and depression that sometimes occurs with anxiety.

Trazodone is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For trazodone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to trazodone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. However, studies in animals have shown that trazodone causes birth defects and a decrease in the number of successful pregnancies when given in doses many times larger than human doses.

Breast-feeding—Trazodone passes into breast milk.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of trazodone in children with use in other age groups.

Older adults—Drowsiness, dizziness, confusion, vision problems, dryness of mouth, and constipation may be more likely to occur in the elderly, who are usually more sensitive to the effects of trazodone.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking trazodone, it is especially important that your health care professional know if you are taking any of the following:

• Antihypertensives (high blood pressure medicine)—Taking these medicines with trazodone may result in low blood pressure (hypotension); the amount of medicine you need to take may change

• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Taking these medicines with trazodone may add to the CNS depressant effects

• Alcohol abuse (or history of)—Drinking alcohol with trazodone will increase the central nervous system (CNS) depressant effects

• Heart disease—Trazodone may make the condition worse

• Kidney disease or
• Liver disease—Higher blood levels of trazodone may occur, increasing the chance of side effects

To lessen stomach upset and to reduce dizziness and lightheadedness, take this medicine with or shortly after a meal or light snack, even for a daily bedtime dose, unless your doctor has told you to take it on an empty stomach.

Take trazodone only as directed by your doctor, to benefit your condition as much as possible.

Sometimes trazodone must be taken for up to 4 weeks before you begin to feel better, although most people notice improvement within 2 weeks.

Dosing—

The dose of trazodone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of trazodone. If your dose is different, do not change it unless your doctor tells you to do so:

• Adults—Oral, to start, 50 milligrams per dose taken three times a day, or 75 milligrams per dose taken two times a day. Your doctor may increase your dose if needed.
• Children 6 to 18 years of age—Oral. Your doctor will tell you what dose to take based on your body weight.
• Children up to 6 years of age—Dose must be determined by the doctor.
• Elderly patients—Oral, to start, 25 milligrams per dose taken three times a day. Your doctor may increase your dose if needed.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is within 4 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to check the medicine's effects and to change the dose if needed.

Do not stop taking this medicine without first checking with your doctor. To prevent a possible return of your medical problem, your doctor may want you to reduce gradually the amount of medicine you are using before you stop completely.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking trazodone together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Trazodone may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and check with your doctor immediately if the following side effect occurs:

• Rare
  • Painful, inappropriate erection of the penis, continuing 
  
  

Also, check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Confusion;  fainting;  muscle tremors 
  
  

• Rare
  • Fast or slow heartbeat;  skin rash;  unusual excitement 
  
  

• Symptoms of overdose
  • Drowsiness;  loss of muscle coordination ;  nausea and vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Dizziness or lightheadedness;  drowsiness ;  dryness of mouth (usually mild);  headache;  nausea and vomiting;  unpleasant taste 
  
  

• Less common
  • Blurred vision;  constipation;  diarrhea;  muscle aches or pains;  unusual tiredness or weakness 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.