Tradon

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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 Tradon

Property Description
Active ingredient Gliclazide (C15H21N3O3S)
Form Tablet (Standard and Modified-release)
Pharmacological class Second-generation Sulfonylurea, Insulin Secretagogue
General Purpose Lowering elevated blood glucose (hyperglycemia)
Origin Synthetic compound

Tradon is a prescription-only oral antihyperglycemic agent used for the management of Type 2 diabetes mellitus. Its foundational component is the active ingredient Gliclazide, which is classified as a sulfonylurea type of antidiabetic medication. This synthetic compound is clinically recognized for its role in supporting metabolic control in adult patients who are non-insulin dependent.

Classification and Pharmaceutical Form

The Gliclazide in Tradon is classified as a second-generation sulfonylurea, a subclass characterized by its favorable efficacy and tolerability profile compared to some older antidiabetic agents. This medication is a single-active ingredient product intended for oral administration, primarily supplied as tablets. A distinctive feature is the availability of the modified-release (MR) tablet design, which is intended to promote more stable and consistent drug concentrations over time.

General Purpose and Mechanism Summary

The general purpose of Tradon is to consistently lower elevated blood glucose levels in individuals whose pancreas is still able to produce some insulin. It achieves this by functioning as an insulin secretagogue: it encourages the functional beta-cells within the pancreas to stimulate the release of more endogenous insulin into the circulation. This action is critical for helping the body process circulating sugar more efficiently, which is the necessary therapeutic step for the sustained management of hyperglycemia in Type 2 diabetes.

Regulatory References

  1. National Library of Medicine, NIH

What side effects are possible with Tradon?

Possible Side Effects and Safety Information

The safety profile of Tradon (Trazodone) is defined by officially documented adverse reactions classified by frequency and affected body system, as detailed in regulatory prescribing information. The most frequently reported adverse effects are categorized as Common or Very Common.


Common Adverse Reactions and System-Organ Effects

Adverse reactions that are frequently observed include effects on the Nervous System such as somnolence (drowsiness), dizziness, and headache. Common effects on the Gastrointestinal System include dry mouth and constipation. The Vascular System is affected by orthostatic hypotension (a drop in blood pressure upon standing). Regulatory documents state that orthostatic hypotension and sedation are often observed more prominently during the initial phase of treatment or following a dose escalation.


Serious Adverse Reactions and Safety Constraints

Several reactions are classified as serious or rare in regulatory documents. These include Priapism (a prolonged erection), Serotonin Syndrome, and various cardiac arrhythmias, such as QT prolongation and the potential for Torsade de Pointes. Serious, rare hematologic and hepatic effects, such as agranulocytosis and severe hepatic disorders, are also documented. The medication is officially constrained from use during the acute recovery phase following a myocardial infarction and is contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs).


Population-Specific Safety Notes

Official safety information notes that older adults may be at an increased risk for specific adverse reactions, including orthostatic hypotension and hyponatremia (low sodium levels). Caution is required when the medication is used in patients with hepatic or renal impairment.

Overdose and Emergency Response

Overdose and When to Seek Help

Tradon overdose is officially documented to present with serious effects on the central nervous system (CNS) and the cardiovascular system. Manifestations listed in regulatory documents include excessive drowsiness, dizziness, lack of coordination, and, in severe cases, seizures and loss of consciousness (coma). Cardiovascular signs reported are irregular heart rhythms (arrhythmias), changes in the QTc interval, and low blood pressure (hypotension).

Specific, life-threatening outcomes reported in regulatory information include cardiac arrest, respiratory arrest, and the development of Serotonin Syndrome, a serious condition characterized by mental status changes, hyperthermia, and unstable vital signs. The official profile notes that the severity of an overdose is significantly increased when Tradon is taken with other serotonergic medicines or CNS depressants.

Since no specific antidote is known, regulatory guidance states that management must be symptomatic and supportive, including close monitoring of vital signs and cardiac function. Immediate medical attention is required if any serious symptoms occur, such as a seizure, collapse, or chest pain. Furthermore, men experiencing an erection lasting longer than six hours (priapism) must discontinue the drug and immediately seek emergency medical care to prevent irreversible tissue damage.

Therapeutic Uses of Tradon

Quick Facts About Tradon

  • Main Indication: Supports the management of major depressive disorder (MDD) in adults.
  • Other Applications: May be used to help manage sleep difficulties (insomnia), particularly those linked to depression.

What Tradon Treats: Main Uses and Benefits

Tradon (Trazodone) is a prescription medication utilized in adult patients to support the management of certain mental health conditions. Its primary approved use is the treatment of major depressive disorder (MDD). This medication may help relieve symptoms associated with depression, such as low mood, loss of interest, and decreased energy.

In addition to its primary use, Tradon is frequently utilized by healthcare providers to help manage sleep difficulties (insomnia). Its effects on certain brain chemicals may promote improved sleep. This can be especially helpful for individuals who experience sleep issues related to their depressive condition or anxiety.

Tradon is one option for healthcare professionals to consider in a comprehensive care plan, which may also include psychotherapy and lifestyle adjustments. It may be used on its own or in combination with other therapeutic approaches to help achieve symptom stability and support a better quality of life.

Eligibility and Restrictions for Use

Who Can and Cannot Use Tradon (Trazodone)

Official regulatory documents define the population eligibility for Tradon by setting strict rules regarding age, concurrent medication use, and specific health conditions.

Eligibility Status

Classification Population/Condition
Approved Population Adults (18 years and older).
Contraindicated Patients with known hypersensitivity to trazodone; patients currently using or who have stopped a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days.
Not Recommended Patients in the initial recovery phase following a myocardial infarction (heart attack).

Restrictions and Special Considerations

Use of Tradon is not approved in pediatric patients (under 18 years), as safety and efficacy have not been established by regulatory authorities. The label requires caution and close monitoring in older adults (geriatric population). Conditional use is also mandatory for patients with severe hepatic or renal impairment, pre-existing cardiac disease, or certain risk factors for bipolar disorder. For women who are pregnant or breastfeeding, the label advises caution and consideration of potential risk.

What should I know about interactions with other medicines?

The official regulatory profile for Tradon (Trazodone) documents several clinically significant drug–drug and drug–substance interactions, broadly classified as pharmacokinetic (altering drug exposure) and pharmacodynamic (additive effects). Co-administration with Monoamine Oxidase Inhibitors (MAOIs), including linezolid and intravenous methylene blue, is contraindicated due to the formally documented risk of serotonin syndrome. A mandatory 14-day washout period must separate the discontinuation of one drug before the initiation of the other.

Interaction Type Interacting Substances (Examples) Official Outcome Description
Exposure Modification Strong CYP3A4 Inhibitors (e.g., ritonavir) Increase Tradon plasma concentration and reduce clearance.
Exposure Modification Strong CYP3A4 Inducers (e.g., carbamazepine) Decrease Tradon plasma concentration and exposure.
Pharmacodynamic Risk Other Serotonergic Agents (e.g., SSRIs, triptans, tryptophan) Increases the documented risk of serotonin syndrome.
Pharmacodynamic Risk CNS Depressants (e.g., alcohol), Antihypertensives Enhancement of effects, including risk of orthostatic hypotension.
Pharmacodynamic Risk Antiplatelet Agents, Anticoagulants (e.g., warfarin) Potential to potentiate the risk of bleeding.

Additionally, regulatory documents state that co-administration may increase the plasma concentrations of Digoxin and Phenytoin. Caution is noted for elderly patients, who may experience a greater risk of orthostatic hypotension when combined with other psychotropic agents.

Mechanism of Action

Receptor Antagonism and Serotonergic Signaling

This mechanism involves acting as an antagonist on specific receptor sites, including Serotonin (5-HT2A) and Histamine (H1) receptors, alongside its activity as a weak Serotonin Transporter (SERT) inhibitor. By blocking these receptors and weakly altering Serotonin availability, the drug initiates a cascade that leads to the reduction of excitatory signaling within CNS arousal pathways and alteration of signaling dynamics related to the sleep-wake cycle.

mu-Opioid Receptor Engagement and Monoamine Reuptake Inhibition

This domain outlines the influence on nociceptive transmission (pain signaling) via two pathways: the agonism of mu-opioid receptors by an active metabolite, and the inhibition of Norepinephrine (NET) and SERT transporters. This dual action modifies the activity levels within nociceptive transmission pathways, resulting in the inhibition of ascending pain signals and increased activity within descending pain inhibitory pathways.

Influencing alpha1-Adrenergic and Vascular Tone

This domain focuses on the drug's action as an alpha1-adrenergic receptor antagonist in both central and peripheral pathways. This blockade interferes with norepinephrine signaling that contributes to the regulation of vasomotor tone and central vigilance. The resulting physiological consequence is a potential reduction in peripheral vascular resistance, which contributes to altered signaling dynamics related to systemic vascular resistance.

Dosage and Administration Information

Administration and Dosing of Tradon

The administration of Tradon is based on a once-daily oral regimen. This medication is indicated for use in adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise.


Official Administration Guidelines

Administration Scope Instruction
Recommended Dose 5 mg orally once daily.
Timing (Meals) Can be taken with or without food.
Route of Administration Oral (swallowed whole).
Missed Dose Rule If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time.
Dose Adjustment No dosage adjustment is explicitly required for patients based on age, renal impairment, or hepatic impairment.
Pediatric Use Safety and effectiveness have not been established in patients below the age of 18; use is not recommended in children and adolescents.
Special Caution When used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin, a lower dose of the secretagogue or insulin may be necessary to minimize the risk of hypoglycemia.

Procedural Summary

Patients should take one 5 mg Tradon tablet once per day at approximately the same time, though the exact time of day is flexible. The tablet should be swallowed whole. The consistency of the daily schedule is key to the therapeutic protocol; in the event of a missed dose, the schedule is restored by avoiding a double dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Tradon

Evidence for Use in Major Depressive Disorder (MDD)

The research examining Tradon for Major Depressive Disorder (MDD) primarily consists of Randomized Controlled Trials (RCTs). These studies were used in research exploring how symptoms change over time and compared the compound against a placebo as well as against active comparators studied in research. Researchers were monitoring outcomes related to systemic or functional imbalance by measuring changes in standardized scales used in research to track symptom intensity. Studies report how symptoms evolved in the observed populations during these trials, which were conducted over defined time intervals, typically during acute periods ranging from four to eight weeks.

Evidence for Supportive Use in Insomnia

Tradon was evaluated in studies exploring short-term symptom changes related to sleep, often applied in studies examining patient-reported experiences. The research base includes trials that focused on individuals with primary insomnia and those whose sleep disruption was often related to comorbid conditions like depression. These studies monitored outcomes related to physical discomfort by using both subjective patient-reported outcomes and objective measures from polysomnography. However, research highlights that findings were mixed across different systematic reviews when analyzing the effect on all objective sleep parameters, such as the time required to fall asleep.

Long-Term Research and Sustained Patterns of Symptom Change

While research has explored short-term symptom changes, studies also monitored patients over defined time intervals to examine outcomes reflecting daily functioning or activity level over longer periods. These studies were primarily conducted to examine the use of Tradon for Major Depressive Disorder, with observation periods extending for six months or more. Evidence contributes to understanding symptom patterns over time. However, long-term effects are not fully established, particularly with the newer formulations.

Key Evidence Gaps and Areas of Uncertainty

Evidence highlights what is known — and what is still uncertain — about Tradon. One key limitation is that evidence quality varies across studies, particularly for supportive uses where follow-up durations were limited. Comparative evidence is lacking in large-scale trials against all recently approved medications, and overall, certainty remains low regarding the long-term effects for conditions characterized by fluctuating or episodic manifestations.

Key Studies & References

  1. TRAZODONE hydrochloride Label (Official U.S. FDA Drug Label for immediate-release formulation, establishing MDD indication and original trial context)
  2. Clinical guidance for the use of trazodone in major depressive disorder and concomitant conditions: pharmacology and clinical practice (Narrative review summarizing comparative efficacy and use in comorbid anxiety/insomnia)
  3. Trazodone effectiveness in depression: impacts of trazodone extended release vs SSRIs on the health status and quality of life of patients with major depressive disorder (Example of modern comparative, long-term, and quality-of-life study)

Frequently Asked Questions (FAQ)

Common questions about Tradon (FAQ)


Q: What is Tradon used for, besides the main conditions listed?

The official, approved indication for Tradon (Trazodone) is for the treatment of Major Depressive Disorder (MDD) in adults. While regulatory information states that the drug may have sedative effects, it has not received official regulatory approval for other conditions.


Q: Is Tradon an SSRI or a different type of medicine?

Tradon belongs to a pharmacological class known as a triazolopyridine derivative. It is specifically classified as a Serotonin Receptor Antagonist and Reuptake Inhibitor (SARI), meaning its mechanism of action is distinct from a Selective Serotonin Reuptake Inhibitor (SSRI).


Q: Can Tradon be used for long-term treatment?

Regulatory documents state that the efficacy for long-term maintenance treatment of Major Depressive Disorder has not been formally evaluated. However, official information requires that the need for continued treatment be periodically reassessed.


Q: Does Tradon cause drowsiness or affect my ability to drive?

Regulatory documents indicate the drug has the potential to cause drowsiness, dizziness, and to impair judgment and motor skills. Official labeling highlights the potential for cognitive and motor impairment and advises caution regarding activities requiring mental alertness, such as driving.


Q: Can Tradon interact with common over-the-counter pain relievers?

Official labeling warns that co-administration with certain over-the-counter pain relievers, specifically Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or aspirin, may be associated with an increased risk of bleeding.


Q: Does Tradon interact with herbal supplements like St. John’s Wort or CBD?

The official warning applies to co-administration with other serotonergic agents (drugs that boost serotonin levels), requiring close monitoring. This caution is based on the increased risk of Serotonin Syndrome.


Q: Can Tradon be taken with other medicines for mental health conditions?

The drug is contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs). Regulatory information requires close monitoring when the drug is combined with other serotonergic agents due to the risk of Serotonin Syndrome.


Q: Do studies show Tradon is effective for anxiety or sleep issues?

The official efficacy studies required for regulatory approval are only cited for Major Depressive Disorder. While the European product information notes that the drug has anxiolytic and sedative effects, its only approved indication remains MDD.


Q: What are the official restrictions or warnings for using Tradon in patients with liver issues?

Official product information contains warnings for use in patients with hepatic (liver) impairment, especially severe impairment, due to associated hepatotoxicity (liver damage). This often necessitates monitoring.


Q: What is the purpose of taking Tradon with food?

Official information indicates the medication is associated with reduced side effects and increased absorption when taken shortly after a meal or light snack.


Q: Why is Tradon sometimes given at night?

Due to the potential for the medication to cause drowsiness, official recommendations associate the administration of a major portion of the daily dose with bedtime.


Q: Is Tradon safe for use during pregnancy or while breastfeeding?

Based on animal data, the medication may cause fetal harm, and the official label advises caution when considering use during pregnancy. Because the drug is excreted in human breast milk, official labeling requires caution when use is considered during breastfeeding.


Q: What information is known about Tradon's long-term safety?

While the drug is often continued for several months to stabilize symptoms, the official efficacy for maintenance treatment beyond acute use has not been formally evaluated in regulatory studies. Periodic reassessment of the need for continued treatment is required.


Q: What parts of the brain does Tradon affect?

The medication is believed to act in the central nervous system (CNS). It works by influencing the activity of serotonin through inhibiting its re-uptake and by blocking specific serotonin receptors (5HT2A) in the brain.


Q: Will I experience withdrawal symptoms if I stop taking Tradon?

Regulatory documents require that a gradual dose reduction be used when discontinuing treatment. Monitoring for withdrawal symptoms may be required during this period.


Q: Is there a risk of becoming dependent on Tradon?

Because the official labeling recommends a gradual reduction in dose and monitoring for withdrawal symptoms upon discontinuation, a physical dependence may be associated with regular, long-term use.


Q: What signs of an allergic reaction to Tradon should I watch for?

Official documents include 'Skin Condition/Edema' (swelling) as a reported adverse reaction in clinical trials. Post-marketing reports have included more severe allergic reactions and hypersensitivity.


Q: Can Tradon cause weight changes (gain or loss)?

Official adverse reaction reports from clinical trial data list both 'Weight Gain' and 'Weight Loss' as side effects reported by a small percentage of patients.


Q: What are the different strengths or forms that Tradon comes in?

Immediate-release tablets are the most common form, available in several strengths, including 50 mg, 100 mg, 150 mg, and 300 mg tablets. Other formulations, such as extended-release tablets and an oral solution, are also available.


Q: How long does Tradon stay in my system after the last dose?

Regulatory pharmacokinetic studies indicate that the elimination of the medication is biphasic, with a terminal elimination half-life generally ranging between 5 and 13 hours.


Q: Does Tradon interact with alcohol?

Official labeling states that Tradon may enhance the effects of Central Nervous System (CNS) depressants, which includes alcohol.


Q: Can people with a history of seizures take Tradon?

Official warnings state that caution is required when administering the medication to patients with epilepsy or a history of seizures.


Q: How often is Tradon typically taken?

The official dosing recommendations generally state that the drug is typically taken daily in divided doses.


Q: What is the maximum amount of Tradon officially allowed per day?

Official labeling defines maximum allowed daily amounts, with different limits based on whether the patient is receiving outpatient or inpatient care.


Q: Is there a generic version of Tradon available?

The drug is widely available as a generic immediate-release tablet under the name Trazodone Hydrochloride.


Q: Are there reported cases of memory issues or confusion while using Tradon?

Official adverse reaction reports from clinical trials list both 'Confusion' and 'Impaired Memory' among the nervous system-related side effects reported by patients.


Q: Can I use Tradon if I have glaucoma?

Official labeling contains a warning regarding the need to avoid use in patients with untreated anatomically narrow angles, which is a risk factor for Angle-Closure Glaucoma.


Q: Can I use Tradon if I have a bleeding disorder?

Official regulatory documents caution that the drug may increase the risk of bleeding, particularly when used alongside other medications that affect coagulation (blood clotting).


Q: How is Tradon eliminated from the body?

The medication is extensively metabolized (broken down) primarily in the liver. Approximately 75% of the drug is then excreted from the body in the urine, mostly in the form of inactive metabolites.

How should Tradon be stored and disposed of?

Tradon (Trazodone Hydrochloride) must be stored and discarded strictly according to official regulatory guidelines to maintain its chemical stability and ensure safety.

Required Storage Conditions

Labeled Storage Temperature: Store at Controlled Room Temperature (20 C to 25 C, with excursions permitted up to 30 C).
Handling Requirements: Keep in a tightly closed container and protect from excess heat, moisture, and freezing.
Child Protection: The medicine must be kept out of the sight and reach of children.

Official Disposal

Disposal Instructions: Utilize a designated drug take-back program or permanent disposal site for unused or expired tablets.
Environmental Restriction: Do not flush down the toilet or pour into a drain; follow FDA guidelines for household trash disposal if a take-back option is unavailable.

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

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Equivalent of Tradon found in:

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