Mytra

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Mytra

Medically reviewed

Rosario Oropesa

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 Mytra

Property Description
Active Ingredient Trazidone
Form Prescription Oral Tablet
Pharmacological Class Serotonin Receptor Antagonist and Reuptake Inhibitor (SARI)
General Purpose Management of mood and sleep disturbances
Origin Synthetic chemical compound

What is Mytra: A Quick Introduction to the Medicine

Mytra is the designated brand name for a pharmaceutical agent containing the active ingredient Trazidone, designed to offer specific general therapeutic support for certain long-term mood and sleep processes. Mytra is exclusively supplied in an oral form as a scored, film-coated tablet, allowing for easy and standardized ingestion. It is generally classified as a prescription-only (Rx) medicine.

This compound represents a synthetic chemical entity, meaning it is carefully manufactured under controlled laboratory conditions rather than being derived from a natural source. The primary goal of Mytra is to modulate key physiological activities related to the central nervous system, acting as a foundational component in a comprehensive treatment plan that is clinically recognized for its long-standing efficacy in this therapeutic area.

Pharmacological Class and Composition of Mytra

Mytra is categorized under the Serotonin Receptor Antagonist and Reuptake Inhibitor (SARI) pharmacological group, which defines the general therapeutic category it belongs to based on its action within the central nervous system. Its formulation is distinct because it relies on the single active ingredient, Trazidone, which differentiates it from combination therapies often used in similar conditions.

The fundamental strength of Mytra lies in Trazidone, which is the sole agent responsible for its targeted effects. The active component is recognized for its profile in influencing serotonin pathways, facilitating its use as a therapeutic tool.

What is Mytra Used For? (General Therapeutic Purpose)

The general therapeutic purpose of Mytra is to aid in the management of mood disorders and associated sleep disturbances, providing systemic support or correction for imbalances that contribute to the condition. It is a medicine prescribed to stabilize a chronic health process, often used in scenarios where a patient requires a therapeutic agent with an established history of safe use to encourage normal sleep patterns alongside mood stabilization. Mytra functions as a longer-term, modulating treatment, focused on addressing the underlying issues of the health concern rather than offering acute relief.

Regulatory References

  1. Trazodone: MedlinePlus Drug Information

What side effects are possible with Mytra?

The safety profile of Mytra, which contains the active ingredient Trazidone, is defined by adverse reactions officially documented in government regulatory sources, categorized by frequency and the body system affected.

Documented Adverse Reactions

Common effects are primarily related to the Central Nervous System and Autonomic functions, often observed during the initial period of treatment. These include drowsiness, sedation, dizziness, fatigue, dry mouth, nausea, and a sudden drop in blood pressure upon standing, known as orthostatic hypotension.

Serious Adverse Reactions officially noted in labeling, though rare, include Priapism (a prolonged, painful erection), the risk of Serotonin Syndrome, and various Cardiac Arrhythmias, such as QT prolongation. Cases of severe hepatotoxicity have also been documented in post-marketing reports.

Regulatory Safety Statements

Official documents highlight specific safety constraints and population considerations:

  • Suicidality Risk: The regulatory profile contains a warning regarding the increased risk of suicidal thoughts and behaviors, particularly in young adults (age 18 to 24), noted early in treatment or following dose adjustments.
  • Older Adults: Increased susceptibility to effects like somnolence, orthostatic hypotension, and hyponatremia (low sodium levels) is recognized in this population.
  • Restrictions: Mytra is not recommended for use during the acute recovery phase of a myocardial infarction (heart attack) and is contraindicated with the use of MAO Inhibitors. The medicine may impair cognitive and motor skills, a safety limitation documented in official sources.

These official classifications define the medicine’s recognized risks, confirming that the incidence and type of adverse reaction may vary based on both the individual patient and the stage of treatment.

Overdose and Emergency Response

Overdose and when to seek help

This section describes the officially documented information regarding Mytra overdose, strictly based on government regulatory labeling.


Documented Overdose Profile

Overdose of Mytra has been officially documented to commonly involve drowsiness and vomiting. Other central nervous system effects include dizziness, headache, tremor, and lack of coordination.

The overdose is classified as potentially severe and life-threatening due to the risk of serious cardiovascular compromise (e.g., irregular heartbeat, low blood pressure, and QT prolongation) and central nervous system events like seizures, respiratory arrest, and coma. Priapism is also a rare but severe documented outcome.

Risk Note: The risk of a fatal outcome is officially documented to increase significantly when Mytra is co-ingested with other CNS depressant drugs (e.g., alcohol).


Required Emergency Actions

The regulatory guidance mandates two core actions:

  1. Seek immediate medical attention for all suspected overdose situations.
  2. Contact a poison control center for management instructions.

Management: No specific antidote is known for Mytra overdose. Management, therefore, centers on intensive symptomatic and supportive treatment, including close monitoring of vital signs and continuous ECG observation to manage cardiovascular risks.

Therapeutic Uses of Mytra

What Mytra Treats: Main Uses and Benefits

Mytra is commonly used to help with conditions characterized by periods of heightened symptoms such as Major Depressive Disorder, addressing core symptoms related to systemic imbalance, including persistent low mood and a loss of interest. As a therapeutic option, the medication is applied across domains where additional symptomatic support is needed. It may assist with managing symptoms that interfere with daily functioning and supports the maintenance of functional stability when symptoms are more noticeable.

The therapeutic benefit of Mytra is relevant for managing symptom clusters that interfere with daily comfort, specifically Major Depressive Disorder, associated insomnia (difficulty falling asleep and staying asleep), and co-occurring anxiety or heightened tension. This application offers symptomatic relief in settings where symptoms are prominent.

“The medication may assist with managing symptoms related to heightened physiological activity, such as generalized tension and irritability.”

Quick Fact: Support for Sleep and Mood Symptoms Mytra contributes to easing the overall symptom burden and may help patients cope more steadily with symptom fluctuations, providing support during episodes of heightened discomfort.

Regulatory References

  1. NIH MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Mytra?

This section defines population eligibility for Mytra (Trazidone) based solely on official regulatory documentation.


Contraindicated Populations

Use of Mytra is contraindicated (strictly prohibited) in patients with a known hypersensitivity to the drug or any ingredient in the formulation, or in patients currently taking a Monoamine Oxidase Inhibitor (MAOI) or who have stopped one within the last 14 days. The medicine is also not recommended for patients during the initial recovery phase following a myocardial infarction (Acute MI).


Age- and Condition-Based Restrictions

Population Group Eligibility Status (Regulatory Wording)
Adults (18+ years) Indicated for use.
Children/Adolescents (<18) Safety and efficacy have not been established; not recommended.
Geriatric Patients (65+ years) Use requires caution; may necessitate a reduced initial starting dose.
Severe Organ Impairment Use with caution in patients with severe hepatic (liver) or renal (kidney) impairment.
Pregnancy/Lactation Use requires caution; potential benefits must be weighed against potential risks to the infant.

Official Eligibility Constraints

Use of Mytra requires caution and monitoring in patients with pre-existing cardiac disease or risk factors for prolonged QTc interval. Patients must also be screened for bipolar disorder and monitored for activation of mania. The medicine should be avoided in patients with untreated angle-closure glaucoma.

What should I know about interactions with other medicines?

Mytra Interactions with other medicines and products

This section outlines important known interactions between Mytra and other prescription medicines, over-the-counter products, or certain substances. Combining Mytra with specific substances can alter the effects or blood levels of either product, potentially leading to inadequate treatment or increased side effects. Always consult with a healthcare professional before starting, stopping, or changing any medications or supplements.


Serotonin-Impacting Agents

Co-administration of Mytra with medicines that increase serotonin levels in the brain can increase the risk of serotonin syndrome, a potentially serious condition. This interaction is primarily pharmacodynamic (involving a direct, additive effect on a body system).

Interacting products include:

  • MAO Inhibitors (MAOIs): Use is contraindicated. A washout period of at least 14 days is required when switching between Mytra and an MAOI (such as phenelzine or tranylcypromine).
  • Triptans: Used for migraine treatment (e.g., sumatriptan).
  • Other Serotonergic Drugs: Including certain opioids (e.g., tramadol, fentanyl), Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), and the herbal supplement St. John's wort.

Central Nervous System (CNS) Depressants

Combining Mytra with other substances that slow CNS activity can result in additive sedation and impairment. This can affect activities requiring mental alertness, such as driving.

Interacting product classes include:

  • Benzodiazepines (e.g., diazepam, alprazolam).
  • Alcohol: Avoid co-use, as it significantly enhances the sedative effects.
  • Other Sedating Agents: Including certain antihistamines and opioid analgesics.

Pharmacokinetic Interactions

Mytra is metabolized by specific liver enzymes, primarily CYP3A4. Agents that affect this enzyme can change Mytra’s concentration in the body (a pharmacokinetic interaction):

  • CYP3A4 Inhibitors (e.g., cimetidine, certain antifungals): Can increase Mytra levels, potentially increasing the risk of side effects.
  • CYP3A4 Inducers (e.g., carbamazepine, rifampicin): Can decrease Mytra levels, potentially reducing its effectiveness. Dosage adjustments may be necessary during co-treatment.

Mechanism of Action

Mytra (Trazodone) modulates central nervous system signaling through a multifaceted pharmacodynamic profile involving high-affinity receptor antagonism and lower-affinity reuptake inhibition.

Dual Antagonism to Modulate Central Arousal

The molecule acts as a rapid and selective antagonist on the Serotonin 5- HT2A receptor and the Histamine H1 receptor. This dual receptor blockade initiates a signaling sequence that reduces the activity of central arousal circuits, resulting in a shift toward decreased central vigilance and the suppression of wake-promoting signals.

Multimodal Serotonin Regulation

At sustained concentrations, the mechanism incorporates weak inhibition of the SERT transporter alongside antagonism of the 5- HT2C receptor. This supports the sustained adjustment of serotonergic activity; the 5- HT2C antagonism counterbalances the consequences of increased synaptic serotonin, influencing the activity of neural circuits.

alpha1 -Adrenergic Receptor Modulation

Antagonism of the alpha1 -adrenergic receptor influences signaling patterns associated with the autonomic nervous system. This action results in alterations to vascular tone and contributes to the overall inhibitory effect on central arousal, which defines the final physiological response profile of the molecule.

Dosage and Administration Information

How Mytra is Used

Mytra is administered exclusively via the oral route as a tablet. The medicine's usage is governed by official protocols detailing the required dosing, frequency, and necessary context for administration.

Administration Scope Official Guideline
Route of Administration Oral administration only (immediate-release or extended-release tablets).
Timing in Relation to Meals Must be taken shortly after a meal or a light snack to mitigate administration-related effects.
Dosing Schedule (Adults) Initial dose is 150 mg per day in divided doses. The dose may be gradually increased every three to four days. Maximum dose is 400 mg per day (outpatient) or 600 mg per day (inpatient).
Age-Group Rules Older adults typically start with a reduced dose, such as 100 mg per day, followed by careful adjustment. Pediatric use is not approved.
Special Procedures Requires gradual dose reduction (tapering) when discontinuing treatment to prevent adverse effects.

The immediate-release formulation follows a divided-dose frequency pattern, typically administered two or more times daily, with the largest portion reserved for bedtime. This scheduling strategy aligns with the drug's properties to support sleep processes. The tablets are scored and can be broken to facilitate dose adjustment, but they must be swallowed whole and not chewed. This established procedural structure defines the standardized, label-based approach to using the medicine, ensuring that administration follows the regulatory guidance for both initiation and eventual cessation of use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Mytra

Evidence for Use in Major Depressive Disorder (MDD)

The clinical evaluation of Mytra for Major Depressive Disorder (MDD) has primarily relied on Randomized Controlled Trials (RCTs) and systematic reviews. Researchers focused on populations of Adults and specific research explored its use in the elderly. These studies monitored how symptoms evolved during defined time intervals, typically spanning 8 to 12 weeks in the acute phase.

Studies used clinical endpoints focused on measuring change using established depression severity scales. Findings from regulatory submissions reported measurements of outcomes related to predefined levels of symptom change and symptom resolution. The evidence is classified as having a High level of establishment, which reflects the historical breadth of data and long-standing regulatory acceptance of the research for this indication.

Evidence for Sleep Disturbances Associated with Mood Conditions

Research explored Mytra's profile for managing sleep problems, particularly insomnia that may occur alongside depression or other conditions. Research examined both subjective reports of sleep quality and objective measures of sleep, such as Total Sleep Time (TST) and continuity. Most of these sleep-focused studies were short-term, covering intervals such as four weeks.

Findings reported how symptoms evolved in the observed populations, with studies describing patterns related to changes in sleep continuity and TST in some cohorts. The evidence base for this clinical situation is generally classified as Moderate.

Understanding the Scientific Limitations and Uncertainties

A key limitation is the reliance on evidence generated by the older, immediate-release formulation, making the long-term profile of the newer extended-release version less comprehensively established. Long-term effects are not fully established across all research scenarios. Data for certain groups, such as children, remain insufficient, and research does not determine whether an individual will respond similarly to observed group patterns.

Frequently Asked Questions (FAQ)

Common questions about Mytra (FAQ)


Q: Can Mytra cause weight changes?

Official regulatory documents, including those used for prescribing, list changes in weight (both gain or loss) as a possible side effect of Mytra. This information is provided to help frame discussions about potential effects.


Q: Are there any common foods or drinks to avoid while taking Mytra?

Official guidelines note to avoid alcohol because it can increase the sedative effects of Mytra. Additionally, Mytra is officially directed to be taken shortly after a meal or light snack as this method is intended to mitigate certain administration-related effects.


Q: Can Mytra be taken with common pain relievers like ibuprofen?

The official prescribing information for Mytra's active ingredient notes that using it with certain pain relievers, specifically NSAIDs (nonsteroidal anti-inflammatory drugs) like ibuprofen, may increase the risk of bleeding. This statement is part of the drug's official warnings and precautions.


Q: Can Mytra affect sleep patterns?

While Mytra is often used in the management of sleep disturbances, official documents list some side effects that can include difficulty falling asleep or staying asleep (insomnia) and restlessness. This indicates that unintended changes in sleep can occasionally occur as an adverse reaction.


Q: Can Mytra be taken on an empty stomach?

Official instructions require Mytra to be taken shortly after a meal or light snack, as official instructions require taking it with food. Taking the medicine without food can lead to higher levels of the drug in the blood, which may increase the risk of side effects such as dizziness or feeling lightheaded.


Q: Is it normal to feel a bit dizzy when starting Mytra?

Dizziness and lightheadedness are listed in the official documents as common side effects, particularly due to a sudden drop in blood pressure when standing up (orthostatic hypotension). These effects may be more noticeable during the initial period of treatment or after a dose adjustment.


Q: Is Mytra safe for people with kidney problems?

Official documents state that Mytra should be used with caution in patients with kidney problems, particularly if the impairment is severe. The prescribing information also notes that the drug's use has not been formally studied in patients with renal impairment.


Q: What is the difference between Mytra and its generic version?

The brand-name Mytra and its generic versions must contain the same active ingredient (Trazidone) and must be proven to work the same way in the body. The main differences are typically limited to the inactive ingredients (like fillers or colorings) used in the tablet formulation.


Q: How is the safety of Mytra monitored after it's approved?

Drug safety continues to be monitored by regulatory bodies after the initial approval through post-marketing surveillance systems. This involves the collection and review of adverse event reports from various sources to identify and manage potential new risks, leading to updates in the official labeling.


Q: Can people with liver issues use Mytra?

Official prescribing information describes that Mytra requires caution in patients with liver problems, especially severe impairment. Official documents also mention that severe liver disorders, including liver failure, have been reported in patients taking the medicine.


Q: Are there any specific lifestyle changes recommended when taking Mytra?

Official warnings include advice such as avoiding alcohol and being cautious when driving or operating machinery due to potential cognitive impairment. It is also advised to sit up or stand slowly to reduce the risk of dizziness or fainting.


Q: Is Mytra safe to use during pregnancy or while breastfeeding?

Official information requires that the potential benefits must be carefully weighed against potential risks to the fetus if used during pregnancy. If the medicine is used until delivery, newborns should be monitored for potential withdrawal symptoms. For breastfeeding, the drug is known to be excreted into human milk, and a determination must be made regarding continued use versus discontinuing the medicine.


Q: What are the ingredients in the Mytra pill/formulation?

The Mytra pill contains the active ingredient Trazidone along with a variety of inactive ingredients (such as fillers and binders) necessary to form the tablet. The complete list of both active and inactive ingredients for each product strength is included in the official prescribing information.


Q: Why is Mytra sometimes prescribed at different strengths?

Mytra is manufactured in different strengths (e.g., 50 mg, 100 mg, 150 mg) to allow for the gradual adjustment of dosage required during the initial treatment phase. These different strengths also accommodate the variations in the final therapeutic dose levels needed for specific patient goals.


Q: What happens if I take more Mytra than prescribed (general information)?

Taking more than the prescribed amount of Mytra may lead to symptoms that can include vomiting, increased drowsiness, changes in heart rate, seizures, and difficulty breathing. Official information indicates that if this occurs, immediate medical attention is necessary.


Q: How long does Mytra stay in your system after the last dose?

The pharmacokinetic data in official documents indicates that Mytra's active ingredient has an elimination half-life ranging approximately from 4 to 15 hours. The half-life is the time it takes for the amount of drug in the body to decrease by half.


Q: Are there any known allergic reactions to Mytra?

Allergic reactions (hypersensitivity) are listed in official documents as a possible, though rare, side effect. Signs that are described as severe may include swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing.


Q: Can Mytra be taken with antacids?

Antacids are generally not listed as a specific interaction that requires dose adjustment or avoidance in the official label. However, official guidance advises that patients should provide their healthcare provider with a complete list of all products, including over-the-counter items like antacids.


Q: Is Mytra a new drug, or has it been around for a while?

The immediate-release formulation of Mytra's active ingredient has a long history, having been approved by the FDA in December 1981. The extended-release formulation received its regulatory approval much later, in February 2010.


Q: What makes Mytra different from older treatments for the same condition?

Historically, the active ingredient in Mytra was noted in early research as having certain properties, such as minimal anticholinergic side effects and low cardiotoxicity, when compared to some older classes of antidepressant medications used for similar conditions.


Q: Why do official documents warn about X risk factor with Mytra?

Warnings are included in official documents to describe risks identified during studies or post-marketing surveillance. For example, the warning about increased risk of suicidal thoughts and behaviors is based on regulatory analyses of clinical trial data involving young adults taking antidepressant drugs. The risk of QT prolongation is due to the drug's known cardiac effect.


Q: What patient groups were included in the main clinical trials for Mytra?

The clinical trials that led to regulatory approval focused primarily on adult patients with the approved indication, and specific research also explored the drug's use in the elderly. Trials typically exclude patient groups with severe co-existing conditions, such as severe heart or liver conditions.


Q: Can Mytra affect blood sugar levels?

Official consumer information for Mytra notes that changes in blood sugar levels have been reported as a side effect. Patients who have diabetes or pre-diabetes should use the drug with caution.


Q: Can Mytra be split or crushed (informational question)?

The immediate-release tablets are scored and may be broken in half to help facilitate dose adjustments. However, the tablets must be swallowed whole and should not be chewed or crushed, unless the specific product label provides an alternative instruction.


Q: Do children or teenagers use Mytra?

Mytra is currently not approved for use in pediatric patients (those under 18 years of age). Official regulatory documents clearly state that the safety and effectiveness have not been established in this population.

How should Mytra be stored and disposed of?

How to Store and Dispose of Mytra

Official regulatory guidelines for Mytra (Trazodone) mandate specific conditions to ensure its stability and safety.

Storage Requirements

Condition Mandate
Temperature Store at Controlled Room Temperature (typically 20 C to 25 C) and do not freeze or expose to excessive heat.
Protection Keep the medicine away from moisture and direct light.
Container Must be kept in the original container and sealed tightly closed to maintain product integrity.

Child Safety and Disposal

It is mandatory to store Mytra out of the sight and reach of children and pets. For disposal, follow local requirements or use a drug take-back program. Do not discard unused or expired tablets in wastewater, such as flushing down the toilet or pouring down a sink.

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

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