Watch for fainting, arrhythmia, and prolonged erection.
Trazodone can cause sedation, low blood pressure, and serious arrhythmia. An erection lasting more than 4 hours requires stopping the drug and emergency care, whether painful or not. Monitor mood and suicidal thoughts early and after dose changes.
Warnings and precautionsIndications
Labeled for adult major depressive disorder.
Labeled oral indications
Immediate-release trazodone hydrochloride tablets are indicated for MDD in adults. Pediatric safety and effectiveness are not established.
Insomnia · Off-label use
Insomnia treatment is outside the selected U.S. label. The AASM 2017 pharmacologic guideline gives a weak recommendation against trazodone for adult sleep-onset or sleep-maintenance insomnia; this is not a universal claim of ineffectiveness. A clinician should reassess the sleep diagnosis, comorbid depression, alternatives, and adverse effects. No insomnia dose is inferred from antidepressant dosing.
Dosage and administration
Use an individualized divided-dose antidepressant regimen.
Immediate-release oral tablets · Adult MDD
| Parameter | Selected label regimen |
|---|---|
| Initial regimen | 150 mg/day in divided doses; start cautiously and increase according to response and tolerance. |
| Titration | May increase by 50 mg/day every 3–4 days. |
| Outpatient maximum | Usually no more than 400 mg/day in divided doses. |
| Inpatient maximum | Up to 600 mg/day in divided doses for more severely depressed patients. |
| Drowsiness | May require moving a larger part of the daily dose to bedtime or reducing the dose, directed by the clinician. |
Administration and discontinuation
Take shortly after a meal or light snack. Swallow whole; only a scored tablet may be halved along its score. Do not chew or crush. The selected 25 mg tablet is unscored; the selected 75 mg tablet is scored. Taper gradually when possible; do not stop abruptly.
MAOI switching and interacting medicines
Allow at least 14 days after a psychiatric MAOI before trazodone and at least 14 days after trazodone before a psychiatric MAOI. Linezolid and IV methylene blue are also contraindicated combinations. Strong CYP3A4 inhibitors may require reducing trazodone; inducers may require an increase based on response. The QT warning may favor avoiding the combination rather than simply adjusting a dose.
Hepatic and renal impairment
Trazodone has not been studied adequately in hepatic or renal impairment in this label; use caution. No validated numeric renal/hepatic adjustment is supplied. Individualize initiation and titration rather than assuming no adjustment is needed.
Safety
Sedation, orthostasis, arrhythmia, serotonin toxicity and priapism require attention.
Warnings and precautions
- Monitor worsening depression, suicidal thoughts, unusual behavior and mania; screen personal/family bipolar history before treatment.
- Serotonin syndrome can occur alone or with other serotonergic drugs. Fever, agitation, sweating, rigidity/tremor, overactive reflexes, diarrhea or seizures needs urgent assessment.
- Avoid with known QT prolongation, significant arrhythmia history, torsades risk (including low potassium/magnesium or symptomatic bradycardia), and QT-prolonging combinations. Not recommended during initial MI recovery.
- Orthostatic hypotension, fainting and sedation can impair driving and increase falls; antihypertensive doses may need review.
- For an erection lasting >4 hours, stop trazodone and seek emergency care, painful or not. Do not wait until 6 hours.
- Bleeding, hyponatremia, mania and acute angle closure are additional concerns. Avoid in untreated anatomically narrow angles; confusion, weakness, unsteadiness or seizure may signal low sodium.
Contraindications
Concomitant MAOIs, including linezolid and IV methylene blue, or trazodone within 14 days after stopping an MAOI. The reverse psychiatric-MAOI interval is also at least 14 days. QT-risk avoidance and other cautions are addressed in the warning section rather than mislabeled as formal section-4 contraindications.
Boxed warning · Suicidal thoughts and behaviors
Antidepressants increased suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Monitor all treated patients for worsening and emerging suicidality. This product is not approved in children.
Adverse reactions
Reported trial effects include drowsiness, dizziness/lightheadedness, dry mouth, constipation, fatigue, blurred vision, headache, nausea and vomiting. Serious risks include arrhythmia, priapism, serotonin toxicity and the other warnings above. Inpatient/outpatient trial rates should not be pooled into an individual risk estimate.
Overdose may cause respiratory arrest, seizures, QT changes, priapism or SIADH; co-ingestion with alcohol or other CNS depressants can be fatal. Seek immediate poison-center/emergency guidance. U.S. Poison Control: 1-800-222-1222.
Drug interactions
CYP3A4, serotonin, bleeding and cardiac effects guide combination decisions.
Clinically relevant interactions
| Combination | Action |
|---|---|
| MAOIs, linezolid, IV methylene blue | Contraindicated combinations; obey washout intervals. |
| Other serotonergic medicines or supplements | Monitor toxicity closely; reconsider unnecessary combinations. |
| Strong CYP3A4 inhibitors: clarithromycin, azole antifungals, selected HIV medicines | Exposure and arrhythmia risk increase; QT warning advises avoidance. If a necessary combination is chosen, dose reduction and close review are required. |
| Strong CYP3A4 inducers: carbamazepine, rifampin, phenytoin, St. John’s wort | Exposure may decline; monitor response and adjust under prescriber direction. St. John’s wort is also serotonergic. |
| QT-prolonging medicines | Avoid because arrhythmia risk is additive. |
| Aspirin, NSAIDs, anticoagulants / antiplatelets | Bleeding risk; monitor INR with warfarin during initiation, changes and discontinuation. |
| Digoxin / phenytoin | Check concentrations before combined treatment and continue monitoring; reduce affected dose if needed. |
| Alcohol, sedatives, antihypertensives | Sedation or hypotension can increase; avoid alcohol and review combined treatment. |
Use in specific populations
Pregnancy, lactation, older age and organ impairment require individualized review.
Pregnancy
Limited published observational data have not identified major birth-defect, miscarriage or other adverse outcome risks, but cannot establish absence of risk. Consider relapse and untreated depression risks before changing therapy; discuss the antidepressant pregnancy registry with the clinician.
Lactation
Trazodone transfers into human milk. Limited postmarketing data have not identified infant adverse effects; milk-production data are lacking. Balance maternal need and breastfeeding benefits with potential infant effects.
Pediatric and geriatric considerations
Pediatric safety/effectiveness are not established and the drug is not approved for children. Use cautiously in older adults, who may be more vulnerable to hyponatremia, orthostasis and sedation.
Hepatic and renal impairment
Use cautiously because studies in these populations are lacking; the label supplies no fixed adjustment. Review interacting medicines, falls and cardiac risks during titration.
Clinical pharmacology
Serotonin reuptake inhibition and receptor antagonism contribute to effects.
Mechanism of action and pharmacodynamics
The antidepressant mechanism is incompletely understood. Trazodone inhibits serotonin reuptake and antagonizes 5-HT₂ receptors; alpha-1 adrenergic antagonism can contribute to postural hypotension.
Pharmacokinetics
- Absorption
- Peak approximately 1 hour fasting or 2 hours with food; meal timing changes exposure.
- Metabolism
- Extensively metabolized, including CYP3A4 formation of active m-chlorophenylpiperazine (mCPP).
- Elimination
- Less than 1% is excreted unchanged in urine; accumulation occurs in some patients.
- Protein binding
- Approximately 89–95% in vitro at therapeutic concentrations.
Monitoring and counseling
Assess mood, alertness, blood pressure and risks from interacting medicines.
Monitoring parameters
- Follow depressive symptoms, suicidal thinking, mania and adherence early and after dose changes.
- Assess daytime sedation, orthostatic symptoms, fainting and falls; review BP-lowering medicines.
- Review rhythm/QT risk, electrolytes when indicated, and symptoms of hyponatremia.
- Monitor INR with warfarin and digoxin/phenytoin concentrations when combined; review CYP3A4 changes.
Patient counseling information
- Take after a meal/light snack and follow titration directions. Do not split an unscored tablet, crush or chew.
- Avoid driving until effects are known; avoid alcohol and discuss other sedating medicines.
- Do not stop suddenly; arrange tapering with the prescriber. Report worsening mood or behavior promptly.
- Seek emergency care for an erection >4 hours or suspected serious arrhythmia/serotonin syndrome.
Product identification
Verify the manufacturer, imprint, scoring and strength.
Representative oral product · Trazodone 75 mg
- Dosage form / strength
- Film-coated immediate-release tablet · 75 mg
- Packager / manufacturer
- TruPharma / Oxford Pharmaceuticals
- Appearance / imprint
- Peach, round, convex, scored · 8 | 86 / O
- Example NDC
- 52817-396-10 · 100 tablets
Dosage forms and strengths
Selected product: 25 mg unscored white round tablet (883 / O) and 75 mg scored peach tablet. Other immediate-release strengths and any extended-release product have separate labeling; their split/crush, food, dose and storage directions must be checked.
Storage and handling
Store selected tablets at 20–25°C in a tight, light-resistant container; dispense/read the Medication Guide. Keep medicines out of children’s reach.
References
Original sources for the clinical and product information.
- DailyMed / National Library of MedicineTrazodone hydrochloride · TruPharma tablets
Full label and Medication Guide; SPL version 4, effective September 3, 2026. Representative 25 and 75 mg tablets.
- American Academy of Sleep Medicine / Scholars@DukeChronic insomnia · AASM 2017 guideline
Public primary guideline abstract via author-affiliated Duke repository; weak recommendation against trazodone for adult sleep-onset/maintenance insomnia. Full guideline text not claimed accessed.