Trazone

Quick links to important sections

Trazone

Selected form

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Trazone

Quick Facts

Property Description
Active ingredient Trazodone hydrochloride
Form Oral tablet (immediate and extended-release)
Pharmacological class Serotonin Antagonist and Reuptake Inhibitor (SARI)
General purpose Modulation of mood-regulating brain chemistry
Origin Synthetic compound; triazolopyridine derivative

What Type of Medication is Trazone?

Trazone is a brand name for a prescription-only medication that contains the synthetic compound Trazodone hydrochloride as its active ingredient. It is formally classified as a Serotonin Antagonist and Reuptake Inhibitor (SARI), placing it within the larger category of second-generation antidepressants. This classification signifies that Trazodone is a psychoactive drug derived from a triazolopyridine structure. Unlike older tricyclic antidepressants, Trazodone possesses a distinct mechanism that is utilized for its ability to stabilize mood in adult patients.

Composition and Available Forms (Tablet)

The foundation of Trazone is the single-ingredient product, Trazodone hydrochloride, designed for the oral route of administration. The primary dosage form is the oral tablet, which is supplied in both standard immediate-release and specialized extended-release preparations. The tablets consist of the active compound combined with pharmaceutical excipients necessary for stability and proper delivery. Trazodone is utilized for its general purpose of addressing symptoms of mood disturbances.

General Purpose of Trazodone as a Psychoactive Agent

The general purpose of this medicine is to promote stability within the central nervous system (CNS) by modulating key chemical signaling pathways. As a psychotropic agent, Trazodone’s function is to adjust the balance of monoamine neurotransmitter effects, specifically involving serotonin activity. This core mechanism allows the medicine to restore equilibrium to the neural processes that govern emotional regulation, serving as a tool for managing states of distress or imbalance.

Regulatory References

  1. Trazodone - StatPearls - NCBI Bookshelf

What side effects are possible with Trazone?

Possible Side Effects and Safety Information

Official regulatory documents classify the potential adverse effects of Trazodone (Trazone) based on the frequency of their occurrence and the physiological system affected. The most frequently encountered adverse reactions are related to the Nervous System and Vascular System.


Frequency-Classified Adverse Reactions

The following is a summary of adverse effects classified by their incidence rate, as documented in regulatory prescribing information:

Classification Examples of Documented Effects
Very Common (ge 1/10) Sedation, somnolence, dizziness, dry mouth.
Common (ge 1/100 to < 1/10) Blurred vision, confusion, headache, nausea, constipation, orthostatic hypotension.
Rare (le 1/1,000) Priapism, seizures, agranulocytosis.

Serious Safety Considerations

The official safety profile highlights several serious adverse reactions. A Boxed Warning is required in regulatory labeling concerning the increased risk of suicidal ideation and behavior in children, adolescents, and young adults (up to age 24) when taking this medication. The profile also lists the risk of Priapism, a urological emergency, and notes the potential for Serotonin Syndrome when Trazodone is used concurrently with other serotonergic agents.


Population and Contextual Safety Notes

Safety statements address risks for specific patient groups and usage patterns. Older adults face an increased susceptibility to effects like orthostatic hypotension, which carries an elevated risk of falls. Adverse effects such as dizziness and orthostatic hypotension are reported to occur more frequently at the initiation of treatment or following a dose increase. Caution is advised in patients with severe hepatic or renal impairment due to the potential for altered drug clearance.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Trazone (Trazodone hydrochloride) overdose outlines specific severe manifestations and mandates clear emergency actions for immediate medical intervention. Documented clinical presentations primarily affect the Central Nervous System (CNS) and the cardiovascular system.

Overdose manifestations include extreme drowsiness progressing to coma, seizures, and potential respiratory arrest. Serious cardiovascular risks documented in official labeling include arrhythmias such as QT prolongation and Torsade de pointes, which are associated with the risk of sudden death. A specific, severe urogenital complication documented is priapism (a prolonged, painful erection). The potential for the life-threatening condition known as Serotonin Syndrome is also recognized as an outcome associated with toxicity.

Regulatory guidance mandates that patients or caregivers seek immediate medical attention for any suspected overdose. Emergency medical services must be contacted immediately if the person is collapsed, cannot be awakened, or has trouble breathing. Immediate medical attention is also required for any prolonged, painful erection. Management is strictly symptomatic and supportive, as no specific antidote is known. Hospital monitoring, including continuous cardiac monitoring, is required due to the risk of serious heart rhythm disturbances. Official documents note that the risk of fatal outcome is increased when overdose involves co-ingestion with substances like alcohol or other CNS depressants.

Therapeutic Uses of Trazone

What Trazone Treats: Main Uses and Benefits

The medication is commonly used to help with the symptoms associated with Major Depressive Disorder (MDD) in adults. Trazone is applied in addressing the core symptoms associated with MDD and is commonly used across conditions presenting with acute episodes of depression. It is relevant for easing symptom clusters that include low mood, anhedonia, and feelings of hopelessness. This medicine contributes to easing the overall symptom load by offering symptomatic relief that helps patients cope more steadily with difficult emotional episodes.

The medication is commonly used in situations involving certain distressing symptoms such as insomnia and agitation, where it may assist with maintaining functional stability. This supportive role is often relevant when symptoms become temporarily overwhelming and assists with maintaining functional stability during symptomatic phases.

“This medicine supports patients during episodes of heightened discomfort by easing symptom burden associated with mood and sleep disturbances.”

Quick Fact Symptom Support
Primary Indication Major Depressive Disorder (MDD)
Symptom Management Insomnia, low mood, agitation, and tension
Supportive Role Contributes to easing the overall symptom load

Regulatory References

  1. DailyMed official label for Trazodone Hydrochloride tablets

Eligibility and Restrictions for Use

The eligibility for Trazone (trazodone hydrochloride) is defined by official regulatory documents, establishing specific rules for who can use the medicine and under what conditions. It is officially approved for use in adults (age 18 and older) for Major Depressive Disorder.

Absolute Contraindications

Official labeling states the medicine must not be used by the following groups:

  • Patients with a known hypersensitivity or allergy to trazodone or any component in the formulation.
  • Patients who are taking, or have stopped taking a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days.
  • Patients in the acute recovery phase of a myocardial infarction (heart attack).

Eligibility by Age and Condition

Population / Condition Regulatory Eligibility Status
Pediatric Patients (<18 yrs) Not approved; safety and efficacy are not established.
Geriatric Patients (65+ yrs) Caution and close monitoring are required due to increased risk of effects like orthostatic hypotension.
Severe Hepatic or Renal Impairment Caution should be exercised; use is restricted to cases where benefit outweighs risk, with monitoring considered.
Pregnancy Caution is advised; adequate human studies are lacking, and use should be considered only if the benefit justifies the potential risk.
Lactation (Breastfeeding) Caution is advised; Trazodone is known to be excreted in human milk.

Eligibility also requires caution and screening for conditions like bipolar disorder, untreated narrow-angle glaucoma, and certain heart diseases (e.g., arrhythmias or conduction disorders).

What should I know about interactions with other medicines?

The regulatory profile of Trazone is structured around specific pharmacokinetic and pharmacodynamic constraints. The most stringent constraint is the formal contraindication for co-administration with Monoamine Oxidase Inhibitors (MAOIs), including linezolid and intravenous methylene blue, due to the high risk of Serotonin Syndrome. A mandatory 14-day washout period is required when starting or stopping either Trazone or an MAOI.

Metabolically, Trazone is a substrate of the CYP3A4 enzyme. Strong CYP3A4 inhibitors (e.g., ketoconazole) increase Trazone exposure, whereas strong inducers (e.g., rifampin, carbamazepine) decrease Trazone exposure.

Pharmacodynamically, combining Trazone with other serotonergic agents (e.g., SSRIs, triptans, St. John's Wort) creates an additive risk of Serotonin Syndrome. Further additive risks include bleeding with antiplatelet agents (e.g., NSAIDs) and CNS depression with alcohol or other sedating agents. Co-administration also results in increased serum concentrations of Digoxin and Phenytoin. Regulatory documents note that elderly patients may experience a greater susceptibility to additive effects such as orthostatic hypotension when co-medication is present. Food timing must be observed as it affects Trazone absorption.

Mechanism of Action

How Trazodone Works: Mechanism of Action

Trazodone's mechanism is defined by its action as a Serotonin Antagonist and Reuptake Inhibitor (SARI). Its physiological effects result from the engagement of four distinct receptor systems and the Serotonin Transporter ( SERT). The resulting changes are time-dependent, with some effects appearing immediately due to high-affinity receptor blockade and others developing over weeks due to required neuroadaptation.


Modulating Serotonin and Emotional Regulation Pathways

Trazodone's mechanism involves interaction with the serotonergic system. The drug is a potent blocker of the 5- HT2A receptor, which modulates how key brain circuits respond to serotonin signaling. Concurrently, it acts as a less potent inhibitor of the SERT, leading to a milder increase in synaptic serotonin levels. This combined action leads to altered signaling within neurochemical pathways governing emotional regulation.


Suppressing Central Arousal and Autonomic Tone

The drug engages high-affinity targets like the Histamine H1 and Alpha-1 Adrenergic (alpha1) receptors. Antagonism at the H1 receptor functionally suppresses signals critical for central arousal and wakefulness. The alpha1 blockade reduces sympathetic signaling centrally and peripherally, leading to a modulation of autonomic tone and vascular resistance. These high-affinity, rapid-onset mechanisms govern the drug’s acute physiological response.

Dosage and Administration Information

Instruction Map: How to use Trazone

This map consolidates instructions for Trazodone hydrochloride administration.


Administration Scope

Instruction Detail
Route of administration Oral route only for tablet, capsule, and solution forms.
Dosing schedule The standard initial dose for the Immediate-Release (IR) tablet is 150 mg per day in divided doses, with the outpatient maximum dose generally not exceeding 400 mg per day. The dose is adjusted by increments of 50 mg every three to four days.
Timing in relation to meals (if applicable) IR tablets must be administered shortly after a meal or light snack. Conversely, the Extended-Release (ER) tablet must be taken on an empty stomach.
Preparation requirements (if applicable) IR tablets are scored and can be broken in half along the score line for dosing flexibility.
Age-group administration rules For older or frail adults, the initial dose is reduced, such as to 100 mg per day in divided doses, with single doses over 100 mg generally avoided. Use is not approved for patients under 18 years of age.
Special procedural conditions ER tablets must not be crushed or chewed to preserve the controlled-release mechanism. Dose adjustments may be necessary when co-administered with strong CYP3A4 inhibitors or inducers.

Resulting Procedural Structure

Procedural step sequence:

  • Initiate treatment with the defined initial daily dose and administer according to the food requirement of the specific tablet form.
  • Increase the dose following the titration schedule up to the maximum daily dose for the setting.
  • Maintain the lowest effective dose for a prolonged duration (e.g., four to six months) following an adequate response.
  • Conclude treatment only by implementing a gradual dose reduction (tapering) process.

Connection to the Overall Use Protocol

The protocol establishes the standardized oral route and specifies distinct numeric dose ranges and titration increments for adults and older adults. This structure governs administration through food timing requirements for the immediate-release and extended-release forms, and requires a gradual dose reduction upon discontinuation to properly conclude the course of use.

Recent Clinical Evidence

Research evidence / Overview of studies for Trazone

This section summarizes the types of clinical research that have been conducted on Trazodone, focusing on the available evidence regarding its use in exploring certain conditions. The information here describes the research landscape, not personalized advice or recommendations.


Evidence for Use in Major Depressive Disorder (MDD)

The core evidence for Trazodone involves numerous Randomized Controlled Trials (RCTs). These short-term activity trials, which often compared Trazodone to a placebo (an inactive substance) or to other active antidepressant medications, were used in research to explore the characteristics of symptoms in adult patients. Researchers primarily focused on outcomes related to systemic or functional imbalance by measuring changes in the overall severity of depressive symptoms using standardized scales.

Studies report how symptoms evolved in the observed populations over the typical follow-up periods of six to eight weeks. These trials described patterns observed in the studies where a proportion of studied patients met the criteria for a symptomatic response or remission during the defined time interval. This evidence contributes to the broader evidence landscape for conditions characterized by fluctuating or episodic manifestations.

Despite the body of available evidence, long-term outcomes are not fully established. While some research extends into the medium term (up to six months) to observe sustained patterns, there is limited information for long-term outcomes and the sustained nature of the findings. Furthermore, many of the older studies were conducted using the immediate-release form of the medication, and comparative evidence is lacking between the extended-release formulation and other established antidepressant formulations.


Evidence for Symptomatic Relief of Sleep Disturbances

Trazodone was studied for its use in exploring sleep disturbances, which often occur alongside mood conditions. Research here includes RCTs and numerous systematic reviews and meta-analyses. Studies monitored patient-reported outcomes describing perceived discomfort related to sleep, with researchers measuring changes in parameters like the total time spent asleep and the frequency of waking up during the night. The research explored short-term symptom changes, typically over a period of just a few weeks.

Findings describe patterns observed in the studies related to changes in short-term sleep measures across various studied populations, including older adults. These studies contribute to understanding symptom patterns and the temporary physiological imbalance that can cause sleep problems.


Research on Anxiety and Agitation Symptoms

Trazodone was evaluated in studies examining symptoms of anxiety and agitation, particularly those associated with a diagnosis of Major Depressive Disorder. This evidence often comes from secondary analysis of data collected in trials primarily designed to look at depression. Researchers used standardized rating scales to monitor changes in anxiety scores and scores related to psychomotor agitation.

The research describes measurements of anxiety symptoms when the medication was observed in patients with comorbid depression. However, findings were mixed when Trazodone was studied for agitation in certain non-depressive populations. The evidence contributes to understanding symptom patterns, but research does not determine whether an individual will respond similarly.


Key Research Gaps and Uncertainties

The research landscape for Trazodone's primary indication is extensive, but the research still presents several key limitations. Evidence quality varies across studies, especially for secondary uses like exploring sleep or agitation. The research indicates that many studies have limited follow-up durations, and long-term effects are not fully established.

Key Studies & References

  1. Trazodone Hydrochloride tablet: Label (Prescribing Information) - DailyMed
  2. TED—trazodone effectiveness in depression: a naturalistic study of the effeciveness of trazodone in extended release formulation compared to SSRIs in patients with a major depressive disorder - Frontiers in Pharmacology (2023)
  3. The efficacy and safety of trazodone for sleep problems in depressive patients: a GRADE-assessed systematic review and meta-analysis of clinical trials - PubMed (2025)
  4. Trazodone: a multifunctional antidepressant. Evaluation of its properties and real-world use - J Gerontol Geriatr (2021)
  5. Trazodone - Alzheimer's Drug Discovery Foundation (Evidence Summary)

Frequently Asked Questions (FAQ)

Common questions about Trazone (FAQ)


Q: Does Trazone cause weight gain or weight loss?

A: According to official regulatory documents, changes in weight have been reported as an adverse effect. These events, which include weight gain or weight loss, are typically described as uncommon in the official product information.

Q: Can Trazone make me feel dizzy or drowsy the next day?

A: Official documents indicate that Trazone may cause common side effects such as somnolence (sleepiness) and dizziness. These effects are noted to occur during use and may affect alertness.

Q: Is Trazone considered addictive or habit-forming?

A: Official product information does not use the term 'addictive' or 'habit-forming.' However, regulatory documents state that concluding treatment requires a gradual dose reduction, known as tapering, to minimize the risk of experiencing a discontinuation syndrome.

Q: How long does Trazone stay in your system?

A: Pharmacokinetic data available in regulatory documents describe the drug's terminal elimination half-life. This measurement, which helps determine how quickly the medicine is cleared from the body, is documented to range from approximately 5 to 13 hours.

Q: Are there any common foods or supplements that interact with Trazone?

A: Official product information notes that Trazone has a known interaction with the herbal supplement St. John's Wort. This supplement is documented to result in decreased Trazone exposure. Official instructions also require immediate-release tablets be taken shortly after a meal, indicating food affects the medicine's absorption.

Q: Can I drive a car while I am taking Trazone?

A: Regulatory labeling addresses functional safety by advising caution regarding activities that require full mental alertness. Because Trazone can cause drowsiness and affect judgment, official advice is against driving or operating complex machinery until an individual knows how the medicine affects them.

Q: What happens if I miss a scheduled amount of Trazone?

A: Official guidance on administration of the medicine advises against taking a double or extra dose to compensate for a missed amount. This guidance is provided to maintain consistency with the defined course of use.

Q: Does Trazone affect blood pressure?

A: Official information indicates that the medicine is documented to cause a common side effect known as orthostatic hypotension (a drop in blood pressure upon standing). This side effect is related to the drug's activity on the vascular system.

Q: Is Trazone safe for women who are pregnant or breastfeeding?

A: Caution is advised in regulatory documents for both pregnancy and breastfeeding. Adequate human studies are lacking regarding use during pregnancy. For breastfeeding, caution is advised because the medicine is known to be excreted in human milk.

Q: Does taking Trazone with food change how it works?

A: Official administration instructions mandate specific timing in relation to meals for different tablet forms. This requirement is in place because the presence of food affects the medicine's absorption and how it is cleared, which is necessary for the intended effect.

Q: What information is available about stopping Trazone after using it for a while?

A: Official documents require that when treatment is concluded, a gradual dose reduction (tapering) process must be implemented. This gradual reduction is required to minimize the risk of a discontinuation syndrome, which is a set of symptoms that can occur after abrupt cessation.

Q: Can Trazone cause anxiety or nervousness to increase?

A: Nervousness is listed in regulatory documents as a less common side effect.

Q: What are the signs that Trazone might not be the right fit for someone?

A: Regulatory documents highlight serious adverse reactions, such as symptoms of Serotonin Syndrome, a prolonged erection (Priapism), or changes toward mania/hypomania.

Q: Does the time of day I use Trazone matter?

A: The time of use is governed by the mandatory administration requirement to take the medicine in relation to meals or on an empty stomach. This specific timing is critical to ensuring the correct absorption and resulting effectiveness of the medicine.

Q: Are there any known issues with taking Trazone long-term?

A: The official research summaries indicate that clinical trials providing data for long-term use, defined as beyond four to six months, are limited. Therefore, long-term outcomes and sustained patterns of use are not fully established in regulatory documents.

Q: Does Trazone affect laboratory test results?

A: The medicine’s metabolite is documented in clinical lab studies to potentially interfere with certain diagnostic screens. This interference can result in false-positive readings for specific substances, such as amphetamines, on some urine drug screening tests.

Q: Is the active ingredient in Trazone available in a generic version?

A: Regulatory drug listings confirm that the active ingredient, Trazodone hydrochloride, is available in a generic form (e.g., Trazodone Hydrochloride tablets, USP), in addition to the brand-name product.

Q: Are there any specific safety warnings for people with glaucoma who use Trazone?

A: Caution is advised for patients who have untreated narrow-angle glaucoma. Official cautions are in place due to a documented risk of angle-closure glaucoma.

Q: How do researchers measure the success of Trazone in clinical trials?

A: In clinical trials, researchers measure outcomes by using standardized scales to evaluate changes in the overall severity of symptoms. For certain studies, they also monitor patient-reported outcomes that describe changes in discomfort related to sleep.

Q: Can Trazone cause changes in mood or emotional state?

A: Official information carries a Boxed Warning about the risk of suicidal thoughts and behavior in certain populations. Furthermore, official warnings note a documented risk of activating mania or hypomania (excessively elevated mood) in some patients.

Q: What is the expected duration of treatment with Trazone?

A: The official protocol suggests that following an adequate response, the medicine is typically maintained at the lowest effective dose for a prolonged duration. This duration is often cited in research as being four to six months.

Q: Does Trazone interact with common pain relievers like ibuprofen or aspirin?

A: Official interaction warnings indicate that combining Trazone with common antiplatelet agents, which include NSAIDs like ibuprofen, is documented to result in an additive risk of bleeding.

Q: Can Trazone be used alongside herbal supplements?

A: Regulatory information specifically lists a known interaction with the herbal supplement St. John’s Wort. This interaction causes a decrease in Trazone exposure in the body.

Q: Does Trazone affect a person's ability to concentrate?

A: Official side effect listings indicate that Trazone can cause effects such as confusion and decreased concentration. These effects relate to the drug's activity in the central nervous system.

Q: Is it necessary to have a medical condition to be eligible for Trazone?

A: The medicine is a prescription-only product that is officially approved for use in adults for the treatment of Major Depressive Disorder.

How should Trazone be stored and disposed of?

Official Storage and Disposal Guidelines

Condition Requirement
Temperature Store at controlled room temperature (20 C to 25 C / 68 F to 77 F). Do not allow the medication to freeze or be exposed to excess heat.
Protection Keep the medicine in its original container, tightly closed, and protected from light and moisture.
Child Safety Always store the product securely out of the sight and reach of children to prevent accidental access.
Stability For containers like HDPE bottles, the product should typically be used within 100 days after opening, as defined in regulatory documents.
Disposal Do not dispose of unused medication in household waste or by flushing it down a sink or toilet. Consult a pharmacist or healthcare provider regarding authorized take-back programs or appropriate local hazardous waste disposal methods for unused product.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Trazone found in:

A-Z Index: