Trazolan 100mg

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Trazolan 100mg

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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 Trazolan 100mg

Quick Facts

Property Description
Active Ingredient Trazodone Hydrochloride
Form Oral Tablet (100 mg strength)
Pharmacological Class Serotonin Antagonist and Reuptake Inhibitor (SARI)
General Purpose Mood stabilization and sleep support
Origin Synthetic compound (Triazolopyridine derivative)

What Type of Medicine is Trazolan 100mg?

Trazolan 100mg is a specific presentation of a prescription-only medication in the form of an oral tablet containing the active compound Trazodone Hydrochloride. This substance is a synthetic compound, chemically classified as a triazolopyridine derivative, and fundamentally belongs to the Serotonin Antagonist and Reuptake Inhibitor (SARI) pharmacological class. Trazodone is distinguished as an atypical antidepressant and a second-generation antidepressant due to its unique chemical structure and complex receptor profile. The medication functions by influencing the balance of chemicals in the brain and is a single-agent product, meaning it contains Trazodone as its sole active pharmaceutical ingredient.


Composition and Unique Pharmacological Profile

The 100mg in Trazolan 100mg specifies the exact dosage strength of Trazodone Hydrochloride delivered within the solid tablet vehicle, which includes necessary solid excipients. The drug's multifunctional character arises from a mechanism that combines mild serotonin transporter (SERT) inhibition with potent 5-HT2A receptor antagonism, a feature that differentiates it from the more selective SSRIs. Its profile is further modulated by antagonism at other sites, including histamine and alpha-1-adrenergic receptors. This dual action as both a serotonin reuptake inhibitor and an antagonist is a clinically recognized property of Trazodone, highlighting its specific pharmacological role.


General Purpose and High-Level Action

The core benefit of Trazolan 100mg stems from its ability to help restore chemical balance in the brain, primarily through its effects on serotonergic activity. This action results in significant anxiolytic properties and a pronounced sedative effect. The overall pharmacological profile is utilized when a patient requires simultaneous support for mood stabilization and effective sleep management. By modulating key neurochemicals, the medicine helps stabilize emotional states, reduce generalized distress, and contribute to the restoration of regular sleep patterns, supporting overall psychological equilibrium.

Regulatory References

  1. National Library of Medicine (NIH)
  2. NIH

What side effects are possible with Trazolan 100mg?

Possible Side Effects and Safety Information

Trazolan (trazodone) has an officially documented safety profile that includes common adverse reactions affecting the nervous, gastrointestinal, and cardiovascular systems, as well as several serious warnings.

Common Adverse Reactions

Adverse effects reported in clinical trials with high frequency often relate to central nervous system depression, including drowsiness, dizziness, fatigue, and blurred vision. Other common events are dry mouth, nausea, constipation, diarrhea, and headache.

Serious and Clinically Significant Adverse Reactions

The FDA label includes a Boxed Warning regarding the increased risk of suicidal thoughts and behaviors in pediatric and young adult patients (up to age 24) using antidepressant medications. Patients of all ages should be closely monitored for worsening depression and the emergence of suicidal ideation, especially during the initial months of treatment or following dosage changes.

Serious, though rare, reactions include:

  • Cardiac Arrhythmias: Trazolan can cause QT prolongation and has been associated with Torsade de Pointes and sudden death, requiring caution in patients with pre-existing heart conditions.
  • Serotonin Syndrome: A potentially life-threatening reaction, especially when used with other serotonergic drugs, characterized by mental status changes, autonomic instability, and neuromuscular abnormalities.
  • Priapism: A prolonged, painful erection that may require immediate medical attention to prevent permanent tissue damage.
  • Orthostatic Hypotension and Syncope: A sudden drop in blood pressure upon standing, which can lead to fainting and a subsequent risk of falls, particularly in older adults.
  • Hyponatremia: A low level of sodium in the blood, often occurring in elderly patients.

Safety Considerations and Limitations

Due to the potential for sedation and cognitive impairment, caution is advised when operating machinery or driving. The drug is generally not recommended immediately following a myocardial infarction. Dose adjustments may be necessary to manage common side effects like drowsiness. Patients with conditions that predispose them to priapism (e.g., sickle cell anemia) or with untreated anatomically narrow angles (risk for angle-closure glaucoma) must use this medication with particular caution.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents define Trazolan overdose based on specific, documented clinical manifestations and required emergency actions. Overdose may present with severe Central Nervous System (CNS) effects, including extreme drowsiness, confusion, vomiting, and lack of coordination (incoordination), potentially escalating to seizures or coma.

The physiological effects documented also include critical cardiovascular toxicity. Serious outcomes involve cardiac arrhythmias, such as QTc prolongation and the life-threatening Torsade de pointes, along with severe hypotension. Respiratory arrest is also documented as a possible severe outcome. Severity is noted to increase significantly when Trazodone is co-ingested with alcohol or other CNS depressants.

Immediate medical attention must be sought if any overdose is suspected. Specifically, regulatory information mandates seeking emergency services if the individual collapses, has a seizure, cannot be awakened, or experiences trouble breathing. An explicit emergency action is required for priapism, a prolonged erection, which mandates immediate discontinuation of the drug and emergency medical attention.

Treatment is strictly symptomatic and supportive, as no specific antidote is known. Management often includes continuous cardiac monitoring (ECG/EKG), monitoring of vital signs, and potentially gastric lavage or activated charcoal, consistent with official regulatory guidance.

Therapeutic Uses of Trazolan 100mg

What Trazolan 100mg Treats: Main Uses and Benefits

Trazolan 100mg is commonly used for managing symptoms associated with Major Depressive Disorder (MDD) in adult patients. The medication is utilized in situations involving certain distressing symptoms associated with depression, playing a role in managing core symptoms such as profound low mood, deep sadness, and the difficult loss of interest or pleasure (anhedonia). The overall benefit may assist with achieving emotional stabilization and contributing to easing the overall symptom load.

The medication is also applied across domains where additional symptomatic support is needed for co-occurring sleep disturbances and psychological tension. It is relevant for managing symptom clusters, including difficulty falling asleep, sleep maintenance difficulty, generalized distress, and excessive worry. This application supports patients during difficult episodes by easing distress and assists with maintaining functional stability.


Quick Fact: Symptomatic Domains

Property Description
Primary Indication Major Depressive Disorder (MDD)
Key Symptom Relief Insomnia (initial and maintenance), Low Mood, Psychological Tension
Typical Context Situations requiring simultaneous mood and sleep support
Patient Benefit Supports the management of sleep patterns and contributes to day-to-day comfort

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Population Eligibility for Trazolan 100mg (Trazodone Hydrochloride)

The eligibility to use Trazolan 100mg is strictly defined by regulatory documents, distinguishing between approved, restricted, and prohibited populations.

Who Must Not Use Trazolan (Contraindications)

Use is absolutely contraindicated in patients with a known hypersensitivity to Trazodone Hydrochloride. It must not be used in patients who are currently taking, or have recently discontinued within the last 14 days, a Monoamine Oxidase Inhibitor (MAOI). The medicine is also contraindicated in those experiencing acute myocardial infarction or acute intoxication with alcohol or hypnotics.

Age-Related Eligibility

Age Group Regulatory Status
Adults (18+ years) Approved for use in this population.
Pediatric (Under 18 years) Not approved or not recommended; safety and efficacy are not established.
Older Adults (65+ years) Use requires caution and close monitoring due to increased risk of specific effects.

Populations Requiring Caution (Restricted Use)

Specific populations require caution, as mandated by official labeling. These include patients with cardiac disease, severe hepatic impairment, or severe renal impairment. Use is generally not recommended during the initial recovery phase of myocardial infarction or in patients with conditions that predispose them to priapism.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Trazolan 100mg (Trazodone Hydrochloride) has documented interaction patterns based on its metabolism and its pharmacodynamic effects, as described in official government regulatory documents.

Contraindicated Combinations and Restrictions

Co-administration is strictly contraindicated with Monoamine Oxidase Inhibitors (MAOIs) intended for psychiatric use, requiring a mandatory 14-day separation period when switching between the two drug types. The combination is also prohibited with other medicinal products documented to prolong the QT interval. The use of Trazolan 100mg is also contraindicated during acute alcohol intoxication.

Metabolic and Pharmacodynamic Effects

The primary pharmacokinetic interaction is mediated by the CYP3A4 enzyme. Strong CYP3A4 inhibitors (e.g., Ritonavir) may increase Trazodone exposure, while strong CYP3A4 inducers (e.g., Carbamazepine) may decrease exposure.

Pharmacodynamic interactions include an increased risk of Serotonin Syndrome when combined with other serotonergic agents (e.g., SSRIs, St. John's Wort). Co-administration with other CNS depressants or alcohol enhances sedative effects. Due to Trazodone’s alpha-1-adrenergic antagonism, an additive risk of orthostatic hypotension is documented when combined with antihypertensive agents. Separately, co-administration with anticoagulants like Warfarin may alter Prothrombin Time/INR, requiring monitoring.

Population Note: Elderly patients are documented to be more susceptible to interaction-related orthostatic hypotension and somnolence.

Mechanism of Action

Targeting Arousal and Vigilance Systems

Trazodone's immediate action results from antagonism of three high-affinity targets: the 5-HT2 A, H1, and alpha1 receptors. This mechanism rapidly suppresses activity in central arousal pathways, leading to decreased physiological arousal and altered sleep architecture. The alpha1 antagonism also influences the autonomic regulation of vascular tone.


Modulation of Synaptic Serotonin Availability

The drug also acts as an inhibitor of the Serotonin Transporter ( SERT), increasing the concentration and duration of serotonin available in the synapse. This mechanism modulates activity within serotonergic pathways by providing the necessary elevated serotonin signaling for subsequent receptor interactions.


Functional Selectivity and Mechanistic Coordination

A core feature is the coordinated action between SERT inhibition and the 5-HT2 A antagonism. This dual action prevents the increased serotonin from binding to receptors associated with excessive neuronal excitation, effectively re-routing the signal toward 5-HT1 A receptors. This process leads to a reduction in overall serotonergic system dysregulation and functional equilibrium.

Dosage and Administration Information

How Trazolan 100mg is Used

Trazolan 100mg is an oral tablet containing Trazodone Hydrochloride, and its administration is based on established protocols. The medication is approved for the oral route of administration and is generally provided in the form of tablets that may be scored for dosing flexibility.

Official Dosing and Administration

The established dosing regimen typically begins with an initial adult dose of 150 mg per day, administered in divided doses. The daily dosage may then be gradually increased by increments of 50 mg per day every three to four days, based on the individual response. The maximum dose for outpatients is usually limited to 400 mg per day, while inpatients may receive up to 600 mg per day.

Key Administration Conditions:

The tablets should be taken shortly after a meal or a light snack. This requirement helps reduce potential gastrointestinal upset and influence absorption. Because the medicine can cause drowsiness, standard protocols recommend administering the major portion of the total daily dose at bedtime. Furthermore, the tablets must be swallowed whole or halved along the score line; they must not be crushed or chewed.

Population Group Official Dosing Rule (Example)
Older/Frail Adults Initial dose is typically reduced to 100 mg per day, given in divided or single night-time doses.
Pediatric (under 18) Use is not recommended; safety and efficacy are not established.

For the duration of use, treatment is generally continued for several months after an initial response. When discontinuing Trazodone, the dosage must be gradually reduced (tapered) rather than stopped abruptly, a procedural instruction used to conclude the course of therapy.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Trazolan 100mg

Evidence for Use in Major Depressive Disorder (MDD)

Research has primarily examined the active ingredient in Trazolan (Trazodone) using short-term, acute-phase Randomized Controlled Trials (RCTs). These studies, typically lasting between 6 and 12 weeks, were used in research exploring how symptoms change over time, comparing Trazodone against a placebo and other established antidepressant medicines. Researchers monitored outcomes related to systemic or functional imbalance by using standardized rating scales to measure changes in overall depression severity and the achievement of clinical response thresholds.

Studies conducted during periods of increased symptom activity report how symptoms evolved in the observed populations. These findings describe patterns observed in the studies, where studies described measurements of reductions in total symptom scores. The research focused on outcomes reflecting daily functioning or activity level and assessing core MDD symptoms, such as those related to mood and motivation.

Long-term outcomes, particularly how to sustain changes and prevent symptoms from returning (relapse), are not fully established by the core regulatory RCTs. While longer-term data exist from observational settings, evidence for maintenance treatment is still emerging, and certainty remains low regarding long-term outcome patterns.


Evidence for Sleep Disturbances Co-occurring with Depression

Research has been studied for the active ingredient using both RCTs and specialized studies that use objective measurements, such as Polysomnography (PSG). This research has explored the use of the medicine for the difficult sleep patterns that often occur alongside depression. Studies focused on outcomes related to physical discomfort and sleep difficulties, such as trouble falling asleep and waking up too early.

Studies focusing on episodes where symptoms become more noticeable indicate that patients experienced measurements of faster sleep onset and increased total sleep time during the study period. Findings described patterns where inner tension and agitation were measured as having decreased in self-reports. The results pertaining to objective sleep measures from PSG studies described patterns of changes in sleep architecture, alongside the observed changes in subjective sleep measures.

However, a key limitation is that major regulatory bodies have not reviewed research for a standalone, primary insomnia indication. The research base is strongest for sleep difficulties considered to be secondary or comorbid with MDD. Furthermore, the sample sizes were modest in many objective sleep studies, meaning the results apply only to the populations studied.

Key Studies & References

  1. Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study
  2. Trazodone in the Management of Major Depression Among Elderly Patients with Dementia: A Narrative Review and Clinical Insights
  3. Trazodone Hydrochloride Tablets FDA Labeling Information (DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Trazolan 100mg (FAQ)

Q: How long does it take for Trazolan to work for depression?

Studies and official information indicate that for the treatment of depression, some positive changes were noted as early as the first week of treatment in clinical trials. However, the time it takes for an individual to notice a full therapeutic effect may vary.

Q: Is Trazolan safe to take if I have a heart condition?

Official prescribing information states that this medicine should be used with caution in patients who have pre-existing heart disease. The medicine is generally not recommended for use during the initial recovery phase following a recent heart attack (myocardial infarction).

Q: Can Trazolan be crushed or chewed?

Official administration instructions indicate that tablets must not be crushed or chewed. The tablets must be swallowed whole or may be broken in half only along the pre-scored line.

Q: What should I do if I miss a dose of Trazolan 100mg?

According to official patient instructions, if a dose is missed, official instructions suggest taking it as soon as it is remembered. However, if it is almost time for the next scheduled dose, skipping the missed dose is advised. The regular dosing schedule should be resumed with the next dose, and taking two doses at once to compensate for a missed dose is generally advised against.

Q: How long does Trazolan stay in your system?

The elimination of the active ingredient follows a two-phase pattern. The half-life—the time it takes for half the drug to be eliminated from the body—is reported to range from approximately 4 to 15 hours. The drug and its byproducts are primarily eliminated from the body in the urine over approximately 72 hours.

How should Trazolan 100mg be stored and disposed of?

How to Store and Dispose of Trazolan 100mg?

The storage and disposal of Trazolan 100mg (Trazodone Hydrochloride) tablets must strictly follow official regulatory requirements to ensure product quality and safety.


Storage Requirements

Trazolan 100mg must be stored at Controlled Room Temperature, which ranges from 20 C to 25 C (68 F to 77 F). The medication must be protected from light and moisture and kept in a tight container. Furthermore, the tablets must be stored out of the sight and reach of children.


Disposal Instructions

Unused or expired Trazolan 100mg must be disposed of in accordance with local regulations for pharmaceutical waste. The tablets should not be discarded via household trash, wastewater, or sewage systems.

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

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