Indicated for the treatment of major depressive disorder (MDD) in adults.

Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Trazodone hydrochloride tablets  is not approved for use in pediatric patients.

Trazodone hydrochloride is not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering trazodone hydrochloride tablets to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including trazodone hydrochloride) may cause cardiac arrhythmias.

The efficacy of trazodone hydrochloride tablets for the maintenance treatment of MDD has not been evaluated.

In patients with bipolar disorder, treating a depressive episode with trazodone or another antidepressant may precipitate a mixed/manic episode. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with antidepressants. Prior to initiating treatment with trazodone, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Rare cases of priapism (painful erections greater than 6 hours in duration) were reported in men receiving trazodone. Trazodone should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease).

Trazodone should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease).

Hyponatremia may occur as a result of treatment with antidepressants. Elderly patients may be at greater risk of developing hyponatremia with antidepressants.

The pupillary dilation that occurs following use of many antidepressant drugs including trazodone hydrochloride may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including trazodone, in patients with untreated anatomically narrow angles.

Withdrawal symptoms including anxiety, agitation and sleep disturbances, have been reported with trazodone.

Trazodone hydrochloride tablets may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.

Clinical studies indicate that trazodone hydrochloride may be arrhythmogenic in patients with preexisting cardiac disease.

Trazodone should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.

Trazodone is not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering trazodone to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including trazodone) may cause cardiac arrhythmias.

Trazodone prolongs the QT/QTc interval. The use of trazodone should be avoided in patients with known QT prolongation or in combination with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin). Concomitant administration of drugs may increase the risk of cardiac arrhythmia.

Drugs that interfere with serotonin reuptake inhibition, including trazodone, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk.

Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including trazodone, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome can also occur when these drugs are used alone.

It is recommended that trazodone hydrochloride tablets should not be used in combination with an MAOI or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should be allowed after stopping trazodone hydrochloride tablets before starting an MAOI.

The concomitant use of trazodone with MAOIs is contraindicated. In addition, do not initiate trazodone in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking trazodone hydrochloride tablets, discontinue trazodone before initiating treatment with the MAOI.

Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug.

The concomitant use of trazodone and strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, indinavi) increased the exposure of trazodone compared to the use of trazodone alone.

The concomitant use of trazodone and strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) decreased the exposure of trazodone compared to the use of trazodone alone.

Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of trazodone can increase digoxin or phenytoin concentrations.

Trazodone may enhance the response CNS depressants such as alcohol or barbiturates.

Published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies: increased fetal resorption and congenital anomalies.

Data from published literature report the transfer of trazodone into human milk.

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• Dosage greater than 400 mg per day for outpatients and 600 mg per day for inpatients. GoToSource

• Use in patients under the age of 18. GoToSource

• Anxiety, insomnia and panic disorder. GoToSource

• Bulimia, benzodiazepine/alcohol dependence, fibromyalgia, central nervous system degenerative diseases, schizophrenia, chronic pain disease, diabetic neuropathy and sexual dysfunction. GoToSource

• Behavioral and psychological symptoms of dementia. GoToSource 

• Non-cardiac chest pain. GoToSource

• Neuroleptic-induced acute akathisia. GoToSource

• Improvement of motor recovery after stroke. GoToSource

• Neuropsychiatric symptoms of alzheimer’s disease. GoToSource

• Tinnitus. GoToSource

Bradycardia (slow heart rate). GoToSource

Priapism (prolonged painful erection). GoToSource

Palinopsia (type of visual disturbance). GoToSource

Suicidal thoughts or actions. GoToSource

Serotonin syndrome or neuroleptic malignant syndrome-like reactions (potentially life-threatening drug reaction), torsades de pointes (life-threatening heart rhythm disturbance), orthostatic hypotension (fall in blood pressure when upright position is assumed and syncope, risk of abnormal bleeding and hyponatremia (low level of sodium in the blood). GoToSource

Angle-closure glaucoma. GoToSource

Mania. GoToSource

Constipation and sedation. GoToSource

QT prolongation, cognitive and motor Impairment and withdrawal symptoms. GoToSource

Lawsuits filed for priapism.