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

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.

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

Trazodone is known to prolong the QT/QTc interval.

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.

Clinical studies indicate that trazodone hydrochloride may be arrhythmogenic in patients with preexisting cardiac disease. Arrhythmias identified include isolated PVCs, ventricular couplets, tachycardia with syncope, and torsade de pointes.

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

Trazodone hydrochloride tablets are not approved for use in treating bipolar depression.

In patients with bipolar disorder, treating a depressive episode with DESYREL 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 DESYREL, 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. DESYREL 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).

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

Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including DESYREL, 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.

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.

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

DESYREL may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks.

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including DESYREL. Cases with serum sodium lower than 110 mmol/L have been reported.

DESYREL is contraindicated in patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome.

The use of DESYREL 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.

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

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

DESYREL may enhance the response CNS depressants.

Drugs that interfere with serotonin reuptake inhibition, including DESYREL, 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. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life- threatening hemorrhages.

Animal studies: increase in congenital anomalies.

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

GoToSource

• Dosage greater than 400 mg/day (in divided doses) for outpatients and adult dosage greater than 600 mg/day (in divided doses) for inpatients. GoToSource

• Use in patients under the age of 18. GoToSource

• Behavioral and psychological symptoms associated with alzheimer’s disease. GoToSource

• Bulimia, benzodiazepine/alcohol dependence, fibromyalgia, schizophrenia, chronic pain and diabetic neuropathy. GoToSource 

• Premature ejaculation. GoToSource

• Non-cardiac chest pain. GoToSource

• Neuroleptic-induced acute akathisia. GoToSource

• Agoraphobia and panic disorder. GoToSource

• Behavioral symptoms of frontotemporal dementia. GoToSource

• Insomnia in somatoform pain disorder. GoToSource 

• Post-traumatic stress disorder. GoToSource

• Tinnitus. GoToSource

• Addiction to psychoactive substances. GoToSource

• Anxiety disorders. GoToSource

• Obsessive-compulsive disorder. GoToSource

Priapism (prolonged painful erections). GoToSource

Orthostatic hypotension (fall in blood pressure when upright position is assumed). GoToSource

Prolonged QT-interval and increased risk of polymorphous ventricular tachycardias. GoToSource

Transient ischemic attacks. GoToSource    

Suicidal thinking and behavior. GoToSource

Serotonin syndrome (life-threatening drug reaction). GoToSource

Hip fractures. GoToSource

Acute hepatitis (inflammation of the liver) and fulminant liver failure. GoToSource

Psychomotor impairment and tolerance. GoToSource

Lawsuits filed for priapism.