Trazodone

Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

• Starting dose: 150 mg in divided doses daily
• May be increased by 50 mg per day every three to four days
• Maximum dose: 400 mg per day in divided doses
• Trazodone hydrochloride tablets should be taken shortly after a meal or light snack
• Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed
• When discontinued, gradual dose reduction is recommended
• Dose Selection An initial dose of 150 mg/day in divided doses is suggested
• The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance
• Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage
• The dose may be increased by 50 mg/day every 3 to 4 days
• The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses
• Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses
• Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response
• Important Administration Instructions Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line

Scored tablets of 50 mg, 100 mg, 150 mg and 300 mg ( 3 ). Trazodone hydrochloride tablets, USP are available in the following strengths: Trazodone hydrochloride tablets USP, 50 mg are white to off white, round-shape, biconvex beveled tablets, bisect on one side and debossed with '05' on other side. …

• Safety and effectiveness in the pediatric population have not been established
• Antidepressants increased the risk of suicidal thoughts and behaviors
• In pediatric patients [ see Boxed Warning, Warnings and Precautions ]

Reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. However, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [ see Box Warning and Warnings and Precautions ]
• Dosage and Administration Advise patients that trazodone hydrochloride tablets should be taken shortly after a meal or light snack
• Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration ] . …

• Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs
• Trazodone hydrochloride tablets are 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 [see Warnings and Precautions , Drug Interactions ]

CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). CYP3A4 Inhibitors: Consider trazodone dose reduction based on tolerability ( 2.5 , 7 ). CYP3A4 Inducers: Increase in trazodone dosage may be necessary ( 2.5 , 7 ). Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). Warfarin: Monitor for increased or decreased prothrombin time ( 7 ). …

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue trazodone and initiate supportive treatment ( 5.2 ). Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3 ) Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4 ). Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5 ). …

Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Cardiac Arrythmias [see Warnings and Precautions ( 5.3 )] Orthostatic Hypotension and Syncope [see Warnin …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/ pregnancyregistry/ antidepressants/ Risk Summary Published …

Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate). The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation and syndrome of inappropriate antidiuretic hormone secretion (SIADH). The reactions reported most frequently have been drowsiness and vomiting. …

9.1 Controlled Substance Trazodone hydrochloride tablets are not a controlled substance. 9.2 Abuse Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.