Trazodone

ATC code

N06AX05

Therapeutic class

Atypical antidepressant · Serotonin Antagonist and Reuptake Inhibitor (SARI)

Forms

oral tablet

Brand names

Trazodone Hydrochloride (US) · Desyrel (US) · Oleptro (US) · Trazodona Cinfa (ES) · Trittico (FR)

Overall confidence

high

Regulatory sources consulted

openfda-label-30db7ddc-f345-457d-a04f-1258502e147e
aemps-cima-ft-83568
CredibleMeds.org
Flockhart Table (Indiana University)
Professional Clinical Knowledge
OpenFDA · N06AX05
RxNorm rxcui 10737 ↗

Approved indications

Treatment of major depressive disorder (MDD) in adults.
Treatment of insomnia, particularly insomnia associated with depression or sleep maintenance insomnia. · off-label

Contraindications

Absolute

Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs.

Clinical warnings

Boxed warning · Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients. Not approved for use in pediatric patients. — FDA
Major warning · Risk of Serotonin Syndrome, cardiac arrhythmias (QT prolongation), orthostatic hypotension and syncope, and priapism. — FDA

Drug interactions

HighMAO Inhibitors (e.g., Phenelzine)N06AF03
Mechanism: Drastic increase in the risk of serotonin syndrome due to additive effects on serotonin.
Recommendation: Contraindicated. Do not use trazodone within 14 days of an MAOI.
FDA label
HighRitonavirJ05AE03
Mechanism: Potent inhibition of CYP3A4, increasing trazodone AUC by 2.4-fold. Increases risk of adverse effects like hypotension, syncope, and arrhythmias.
Recommendation: Consider a substantial reduction in trazodone dose and monitor closely. Avoid if possible.
FDA label
ModerateCarbamazepineN03AF01
Mechanism: Induction of CYP3A4, reducing trazodone plasma concentrations by 76%, which may lead to loss of efficacy.
Recommendation: Monitor clinical response. An increase in trazodone dosage may be necessary.
FDA label
ModerateAlcoholV03AB16
Mechanism: Additive CNS depressant effect, potentiating drowsiness, dizziness, and psychomotor impairment.
Recommendation: Advise patients to avoid or limit alcohol consumption during treatment.
FDA label

Adverse events

Common (≥1%)

drowsiness · dizziness · dry mouth · headache · nausea · fatigue · blurred vision

Rare but serious

priapism · cardiac arrhythmias · serotonin syndrome · suicidal ideation · hyponatremia · syncope

Pregnancy and lactation

Human data have not identified a clear risk of major birth defects. However, data are limited. It is excreted in breast milk in small amounts; caution should be exercised.