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traZODone (Monograph)

Drug class: Serotonin Modulators
VA class: CN609
CAS number: 25332-39-2

Medically reviewed by on Mar 18, 2024. Written by ASHP.


  • Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Trazodone is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)

  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and was reduced in adults ≥65 years of age with antidepressants compared with placebo.

  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.

  • Appropriately monitor and closely observe all patients who are started on trazodone therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)


Antidepressant; serotonin modulator.

Uses for traZODone

Major Depressive Disorder

Management of major depressive disorder with or without anxiety.

Effective in both inpatient and outpatient settings.

Schizophrenic Disorder

Has been used for the short-term management of depressive episodes in patients with schizophrenia [off-label].

Alcohol Dependence

Has been used as adjunctive therapy for the management of alcohol dependence [off-label].

Anxiety States

Has been used for the management of anxiety states [off-label].

traZODone Dosage and Administration



Oral Administration

Administer orally after a meal or a light snack.

If drowsiness occurs, administer a major portion of the daily dosage at bedtime or reduce dosage.


Available as trazodone hydrochloride; dosage is expressed in terms of the salt.


Major Depressive Disorder

Initially, 150 mg daily, given in divided doses. Daily dosage may be increased in 50-mg increments every 3 or 4 days based on patient’s response and tolerance.

Prescribing Limits


Major Depressive Disorder

Maximum 400 mg daily.

Hospitalized Patients

Maximum 600 mg daily.

Cautions for traZODone




Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs. However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

Appropriately monitor and closely observe patients receiving trazodone for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments. (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality. Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms. If decision is made to discontinue therapy, taper trazodone dosage as rapidly as is feasible but consider risks of abrupt discontinuance.

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.

Bipolar Disorder

May unmask bipolar disorder. Trazodone is not approved for use in treating bipolar depression.

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.


Risk of developing priapism; may require surgical or pharmacologic (e.g., epinephrine) intervention and result in impotence or permanent impairment of erectile function.

Perform pharmacologic or surgical interventions under the supervision of a urologist or a physician familiar with the procedure; procedures should not be initiated without a urologic consultation if priapism persists for >24 hours.

Discontinue immediately if prolonged or inappropriate erections occur.

Cardiovascular Effects

Possible cardiac arrhythmias (e.g., PVCs, VT); use with caution in patients with preexisting cardiovascular disease.

Do not use during initial recovery phase of MI.

Hypotension, including orthostatic hypotension and syncope, reported.

Concomitant administration of antihypertensive therapy may require a reduction in dosage of the antihypertensive agent(s).

General Precautions

Elective Surgery

Discontinue several days prior to surgery requiring general anesthesia whenever possible.

CNS Effects

Drowsiness reported in up to 50% of patients.

Performance of activities requiring mental alertness and physical coordination may be impaired.

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated; avoid concomitant use.

Specific Populations


Category C.


Not known whether trazodone is distributed into milk; caution advised.

Pediatric Use

Safety and efficacy not established in children <18 years of age.

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during the first few months of antidepressant treatment compared with placebo in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others). However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation. No suicides occurred in these pediatric trials.

Carefully consider these findings when assessing potential benefits and risks of trazodone in a child or adolescent for any clinical use. (See Suicidality in the Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Common Adverse Effects

Drowsiness, dry mouth, dizziness or lightheadedness, headache, blurred vision, nausea or vomiting.

Drug Interactions

Metabolized by CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors or inducers of CYP3A4: Potential pharmacokinetic interaction (altered plasma trazodone concentrations).

Specific Drugs




Anesthetics, general

Experience limited

Discontinue trazodone for as long as clinically feasible prior to elective surgery

Antifungals, azoles (e.g., itraconazole, ketoconazole)

Substantially increased plasma trazodone concentrations possible, with potential for adverse effects

If used concomitantly, consider reduction in trazodone dosage


Substantially decreased plasma concentrations of trazodone and active metabolite, m-chlorophenylpiperazine

Closely monitor during concomitant use; increase trazodone dosage if necessary

CNS depressants (e.g., alcohol, anesthetics, barbiturates, opiates or other analgesics, other sedatives)

Additive CNS depressant effects (e.g., sedation)

Use with caution


Increased serum digoxin concentrations

Monitor for digoxin toxicity


Increased plasma trazodone concentrations

Potential for serotonin syndrome

Observe for adverse effects; monitor trazodone concentrations; adjust dosages as needed

Hypotensive agents

Potential additive hypotensive effects

Adjust dosages as needed


Substantially increased plasma trazodone concentrations possible, with potential for adverse effects

If used concomitantly, consider reduction in trazodone dosage

MAO inhibitors

Limited experience

Initiate trazodone therapy cautiously if MAO inhibitors are discontinued shortly before or are to be given concomitantly with trazodone


Substantially increased plasma trazodone concentrations possible, with potential for adverse effects

If used concomitantly, consider reduction in trazodone dosage


Increased serum phenytoin concentrations


Increased peak plasma concentration, AUC, and half-life and decreased clearance of trazodone; increased incidence of adverse effects of trazodone also observed

If used concomitantly, consider reduction in trazodone dosage

Serotonergic agents (e.g., buspirone, dextropropoxyphene, phenelzine)

Potential for serotonin syndrome



Increased or decreased PT

traZODone Pharmacokinetics



Rapidly and almost completely absorbed from the GI tract; peak plasma concentration usually attained within 1–2 hours.


Antidepressant effects evident within 1 week; optimal antidepressant effects usually attained after 2–4 weeks.


Food reduces peak plasma concentrations, delays time to peak plasma concentration, and increases extent of absorption.



Distribution into human body tissues and fluids not determined.

Widely distributed; crosses the blood-brain barrier and the placenta in animals.

Distributed into milk in rats; not known whether trazodone is distributed into milk in humans.

Plasma Protein Binding




Extensively metabolized in the liver via hydroxylation, oxidation, N-oxidation, and splitting of the pyridine ring. In vitro studies indicate metabolism by CYP3A4 to an active metabolite, m-chlorophenylpiperazine; other metabolic pathways not well characterized.

Elimination Route

Excreted principally in urine (70–75%) as metabolites and in feces via biliary elimination.


5–9 hours.





Room temperature. Protect from temperatures >40°C.


Advice to Patients


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

traZODone Hydrochloride


Dosage Forms


Brand Names




150 mg*

Trazodone Hydrochloride Dividose (with povidone; scored)


300 mg*

Trazodone Hydrochloride Tablets


AHFS DI Essentials™. © Copyright 2024, Selected Revisions March 27, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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