TRAZ-oh-done

Commonly used brand name(s)

In the U.S.

• Desyrel
• Desyrel Dividose
• Oleptro

Available Dosage Forms:

• Tablet
• Tablet, Extended Release

Therapeutic Class: Antidepressant

Chemical Class: Triazolopyridine

Uses For trazodone

Trazodone is used to treat depression. It is thought to work by increasing the activity of serotonin in the brain. Trazodone is an antidepressant.

trazodone is available only with your doctor's prescription.

Before Using trazodone

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 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of trazodone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trazodone extended-release tablets in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood), which may require caution in patients receiving trazodone.

No information is available on the relationship of age to the effects of trazodone regular tablets in the elderly.

Pregnancy

Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using trazodone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride
• Dronedarone
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Metoclopramide
• Moclobemide
• Pargyline
• Phenelzine
• Pimozide
• Posaconazole
• Procarbazine
• Rasagiline
• Saquinavir
• Selegiline
• Sparfloxacin
• Tranylcypromine

Using trazodone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Almotriptan
• Amiodarone
• Amitriptyline
• Amoxapine
• Amphetamine
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azithromycin
• Brompheniramine
• Buspirone
• Carbamazepine
• Chloroquine
• Chlorpheniramine
• Ciprofloxacin
• Citalopram
• Clomipramine
• Clozapine
• Cobicistat
• Cocaine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Desipramine
• Desvenlafaxine
• Dextroamphetamine
• Dextromethorphan
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Doxepin
• Droperidol
• Duloxetine
• Eletriptan
• Erythromycin
• Escitalopram
• Fenfluramine
• Fentanyl
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Gatifloxacin
• Gemifloxacin
• Ginkgo
• Granisetron
• Halofantrine
• Haloperidol
• Hydroxytryptophan
• Ibutilide
• Iloperidone
• Imipramine
• Lapatinib
• Levofloxacin
• Lithium
• Lopinavir
• Lorcaserin
• Lumefantrine
• Mefloquine
• Meperidine
• Methadone
• Mifepristone
• Milnacipran
• Moxifloxacin
• Naratriptan
• Nefazodone
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ondansetron
• Paliperidone
• Paroxetine
• Pazopanib
• Pentazocine
• Perflutren Lipid Microsphere
• Primidone
• Procainamide
• Propafenone
• Propoxyphene
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Rizatriptan
• Salmeterol
• Sertraline
• Sibutramine
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sumatriptan
• Sunitinib
• Telithromycin
• Terfenadine
• Tetrabenazine
• Toremifene
• Tramadol
• Trimipramine
• Tryptophan
• Valproic Acid
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Voriconazole
• Ziprasidone
• Zolmitriptan

Using trazodone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Chlorpromazine
• Clarithromycin
• Digoxin
• Fosphenytoin
• Foxglove
• Indinavir
• Itraconazole
• Ketoconazole
• Phenytoin
• Ritonavir
• Thioridazine
• Tipranavir
• Trifluoperazine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of trazodone. Make sure you tell your doctor if you have any other medical problems, especially:

• Behavior or mood changes (eg, aggression, panic attacks) or
• Bipolar disorder (mood disorder with mania and depression), or risk of or
• Heart rhythm problems (eg, QT prolongation) or
• Hyponatremia (low sodium in the blood) or
• Hypotension (low blood pressure) or
• Mania or hypomania (mood disorders), history of or
• Priapism (painful or prolonged erection of the penis)—Use with caution. May make these conditions worse.

• Heart attack, recent—Use is not recommended in patients with this condition.

• Heart disease or
• Heart rhythm problems (eg, QT prolongation), family history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. May cause side effects to become worse.

Proper Use of trazodone

Take trazodone only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

trazodone should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To lessen stomach upset and to reduce dizziness and lightheadedness, take the regular tablet with or shortly after a meal or light snack.

Take the extended-release tablet at the same time each day, preferably at bedtime, without food.

The tablet can be swallowed whole or given as a half tablet by breaking the tablet along the score line. Do not break the tablet unless your doctor tells you to. Do not crush or chew the tablet.

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.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For depression:
  • For oral dosage form (extended-release tablets):
    • Adults—At first, 150 milligrams (mg) per day as a single dose. Your doctor may adjust your dose as needed. However, the dose is usually not more than 375 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—At first, 150 milligrams (mg) per day, given in divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of trazodone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using trazodone

It is very important that your doctor check your progress at regular visits, to allow for changes in your dose and to help manage any unwanted effects.

Do not take trazodone with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking trazodone during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping trazodone before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Trazodone may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use trazodone with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue, tryptophan, St. John's wort, or some pain or migraine medicines (eg, sumatriptan, tramadol, Frova®, Maxalt®, Relpax®, Zomig®).

For some teenagers and young adults, trazodone can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself or others. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family have bipolar disorder (manic-depressive disorder) or have tried to commit suicide.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of serious conditions called serotonin syndrome and neuroleptic malignant syndrome-like reactions. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Contact your doctor right away if you have any changes in your heart rhythm such as feeling dizzy or faint, or having a fast, pounding, or uneven heartbeat. These could be symptoms of a heart problem called QT prolongation.

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

Do not stop taking trazodone without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, irritability, restlessness, or trouble sleeping.

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

trazodone will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using trazodone.

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

Trazodone may cause dry 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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

trazodone Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• lightheadedness
• sweating
• unusual tiredness or weakness

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion about identity, place, and time
• decreased concentration
• fainting
• general feeling of discomfort or illness
• headache
• lack of coordination
• muscle tremors
• nervousness
• pounding in the ears
• shortness of breath
• slow or fast heartbeat
• swelling

Rare

• Skin rash
• unusual excitement

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dry mouth (usually mild)
• muscle or bone pain
• trouble sleeping
• trouble with remembering
• unpleasant taste

Less common

• Constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• diarrhea
• hearing loss
• muscle aches or pains
• weight loss

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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Usual Adult Dose for Depression

Immediate-release tablets:
Initial dose: 150 mg per day in divided doses.
Maintenance dose: May be increased by 50 mg per day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg per day in divided doses. Inpatients may be given up to but not in excess of 600 mg per day in divided doses.
Trazodone should be taken shortly after a meal or light snack.

Extended-release tablets:
Recommended starting dose: 150 mg once daily
Maintenance dose: The dose may be increased by 75 mg/day every three days (for example, start 225 mg on day 4 of therapy).
Maximum daily dose: 375 mg
Trazodone extended-release tablets should be taken orally at the same time every day, in the late evening preferably at bedtime, on an empty stomach. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Patients should be monitored for withdrawal symptoms when discontinuing treatment with trazodone hydrochloride. The dose should be gradually reduced whenever possible.

The efficacy of trazodone extended-release tablets for the maintenance treatment of MDD has not been evaluated. While there is no body of evidence available to answer the question of how long a patient treated with trazodone extended-release tablets should continue the drug, it is generally recommended that treatment be continued for several months after an initial response. Patients should be maintained on the lowest effective dose and be periodically reassessed to determine the continued need for maintenance treatment.

Usual Geriatric Dose for Depression

Immediate-release tablets:
Initial dose: 150 mg per day in divided doses.
Maintenance dose: May be increased by 50 mg per day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg per day in divided doses. Inpatients may be given up to but not in excess of 600 mg per day in divided doses.
Trazodone should be taken shortly after a meal or light snack.

Extended-release tablets:
Recommended starting dose: 150 mg once daily
Maintenance dose: The dose may be increased by 75 mg/day every three days (for example, start 225 mg on day 4 of therapy).
Maximum daily dose: 375 mg
Trazodone extended-release tablets should be taken orally at the same time every day, in the late evening preferably at bedtime, on an empty stomach. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Patients should be monitored for withdrawal symptoms when discontinuing treatment with trazodone hydrochloride. The dose should be gradually reduced whenever possible.

The efficacy of trazodone extended-release tablets for the maintenance treatment of MDD has not been evaluated. While there is no body of evidence available to answer the question of how long a patient treated with trazodone extended-release tablets should continue the drug, it is generally recommended that treatment be continued for several months after an initial response. Patients should be maintained on the lowest effective dose and be periodically reassessed to determine the continued need for maintenance treatment.

In the clinical trial, there were nine patients older than 65. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical literature and experience with trazodone have not identified differences in responses between elderly and younger patients. However, as experience in the elderly with trazodone extended-release tablets is limited, it should be used with caution in geriatric patients.

Antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients who may be at greater risk for this adverse reaction.

Usual Pediatric Dose for Depression

(Not approved by FDA)
Immediate-release tablets:
6 to 12 years:
Initial dose: 1.5 to 2 mg/kg/day in divided doses.
Maintenance dose: May increase up to 6 mg/kg/day in 3 divided doses.

Greater than 12 years to 18 years:
Initial dose: 25 to 50 mg per day.
Maintenance dose: May increase up to 100 to 150 mg per day in divided doses.

Trazodone should be taken shortly after a meal or light snack.

Renal Dose Adjustments

Because the metabolites of trazodone are eliminated by the kidneys, and at least one such metabolite may be active, use of trazodone is not recommended for use in patients with renal dysfunction.

Liver Dose Adjustments

The disposition and safety of trazodone in patients with liver dysfunction has not been described. Therefore, if trazodone must be used, it should be used very cautiously. Consideration should be given to the use of alternative therapies in patients with liver dysfunction.

Dose Adjustments

Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Precautions

The use of MAOIs intended to treat psychiatric disorders (and other MAOIs such as linezolid and intravenous methylene blue) with trazodone or within 14 days of stopping treatment with trazodone is contraindicated due to an increase in the risk of serotonin syndrome. The use of trazodone within 14 days of stopping an MAOI intended to treat psychiatric disorders (and other MAOIs such as linezolid and intravenous methylene blue) is also contraindicated.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Because the metabolites of trazodone are eliminated by the kidneys, and at least one such metabolite may be active, use of trazodone is not recommended for use in patients with renal dysfunction.

Other Comments

Symptomatic relief may be seen during the first week, with optimal antidepressant effects typically evident within 2 weeks.

Trazodone extended-release tablets are scored to provide flexibility in dosing. Trazodone extended-release tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. Breaking the tablet in half does not affect the controlled-release properties of the tablet.

In order to maintain its controlled-release properties, trazodone extended-release tablets should not be chewed or crushed.

Trazodone Side Effects