Mirtaz

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Mirtaz

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 Mirtaz

Property Description
Active ingredient Mirtazapine
Form Tablets (Film-coated, Orally Disintegrating - ODT)
Pharmacological class Noradrenergic and Specific Serotonergic Antidepressant (NaSSA)
General purpose Mood stabilization and Antidepressant agent
Origin Synthetic compound

What Type of Medicine is Mirtazapine?

Mirtaz is a prescription-only psychotropic agent containing the active ingredient Mirtazapine, a synthetic compound utilized to help restore emotional balance. It is clinically recognized as an atypical antidepressant, distinctly categorized as a Noradrenergic and Specific Serotonergic Antidepressant (NaSSA). This classification reflects its unique mode of action, which involves the specific modulation of key brain chemicals (neurotransmitters) that influence mood, differing from the action of Selective Serotonin Reuptake Inhibitors (SSRIs). This mechanism helps restore the balance of certain natural substances in the brain.

Composition and Available Forms

The core composition of Mirtaz is the single active substance, Mirtazapine, which is derived from the piperazino-azepine chemical group. Mirtaz is designed for oral administration and is supplied in two main pharmaceutical preparations: the conventional film-coated tablets and the orally disintegrating tablets (ODT). The ODT form is a distinguishing feature, as it is specifically engineered with specialized excipients to dissolve rapidly on the tongue without needing water for swallowing.

General Purpose of Mirtazapine Therapy

The overall purpose of Mirtazapine therapy is to act as an antidepressant agent that helps stabilize mood and improve overall emotional well-being. By facilitating the function of mood-critical neurotransmitters through its unique receptor-antagonism mechanism, Mirtazapine provides targeted pharmacological support for the central nervous system. A typical, neutral use scenario involves utilizing the medicine as part of a regimen to support mental balance and emotional regulation.

What side effects are possible with Mirtaz?

Possible Side Effects and Safety Information: Mirtazapine

This section outlines possible side effects and safety information strictly documented in government regulatory sources (e.g., FDA, EMA). It is not a guide for use or a medical recommendation.


Frequency-Classified Adverse Reactions

Side effects are categorized by frequency of occurrence, as defined in regulatory labeling:

Classification Examples of Documented Reactions
Very Common (ge 1/10) Somnolence/Sedation, Increased Appetite, Weight Gain, Dry Mouth.
Common (ge 1/100 to < 1/10) Dizziness, Headache, Constipation, Lethargy, Peripheral Edema.
Rare (ge 1/10,000 to < 1/1,000) Elevation in serum transaminases (liver enzymes).
Very Rare (< 1/10,000) Agranulocytosis (Bone Marrow Depression).
Not Known (Frequency cannot be estimated) Serotonin Syndrome, Hyponatremia.

Serious Adverse Reactions

Regulatory documents highlight rare but clinically serious adverse reactions that require immediate attention:

  • Suicidal Thoughts and Behavior: Risk is increased in children, adolescents, and young adults (up to age 24), especially when starting treatment or adjusting the dosage.
  • Agranulocytosis: A severe drop in white blood cell count; symptoms like fever, sore throat, or other signs of infection warrant immediate monitoring.
  • Serotonin Syndrome: A potentially life-threatening condition associated with confusion, agitation, rapid heart rate, and severe muscle rigidity.
  • QTc Prolongation: Caution is advised, particularly in patients with pre-existing heart conditions or when used with other medications that affect heart rhythm.

Safety Restrictions and Monitoring

  • Contraindications: Use is prohibited within 14 days of taking a Monoamine Oxidase Inhibitor (MAOI). The orally disintegrating tablet form is restricted for use in patients with Phenylketonuria (PKU) due to the presence of phenylalanine.
  • Special Populations: The medicine is generally not recommended for use in pediatric patients. Caution and dose reduction may be necessary for patients with moderate to severe hepatic or renal impairment due to reduced clearance.

Overdose and Emergency Response

Mirtaz Overdose and when to seek help

The official regulatory documents state that an overdose of Mirtazapine is typically characterized by documented clinical manifestations such as drowsiness (somnolence), disorientation, impaired memory, and tachycardia (accelerated heart rate). Severe outcomes, including fatalities, have been reported, predominantly when Mirtazapine was ingested in combination with other pharmacological agents (mixed overdose). The potential for a Serotonin Syndrome reaction is a serious documented concern, which requires immediate clinical assessment.

Required Emergency Actions

Due to the potential for severe and life-threatening complications, regulatory guidance mandates that patients seek immediate medical attention upon suspected overdose. Management is primarily symptomatic and supportive, aiming to ensure an adequate airway, oxygenation, and ventilation for the patient. Required procedures include continuous monitoring of cardiac rhythm and vital signs; no specific antidote for Mirtazapine overdose is documented in official labeling.

Population Considerations

Official prescribing information notes that patients with moderate to severe renal or hepatic impairment experience reduced clearance of Mirtazapine. This reduction may lead to elevated systemic drug exposure, potentially increasing the severity of the overdose symptoms in these populations.

Therapeutic Uses of Mirtaz

What Mirtaz Treats: Main Uses and Benefits

Mirtazapine is primarily an antidepressant agent commonly used to help with Major Depressive Disorder (MDD), addressing the full scope of emotional, cognitive, and physical symptoms associated with this condition. The medication is commonly used to treat depression and is generally considered relevant in situations where patients experience moderate to severe illness.

This medication is applied in addressing symptom clusters that may become disruptive, including core depressive affect, vegetative symptoms, and associated anxiety. It is primarily used for major depressive episodes, but may be part of symptomatic management for co-occurring anxiety or situations involving severe insomnia and significant appetite loss during acute phases. Its role is considered relevant to provide support that helps ease the overall symptom burden during difficult episodes. By addressing these areas, the treatment assists with maintaining functional stability and supports patients during episodes of heightened discomfort.


Quick Fact: Relief for Sleep and Appetite Mirtazapine is considered relevant when depression is complicated by prominent, debilitating insomnia and a low appetite, contributing to general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Mirtaz — Official Regulatory Information

The eligibility profile for mirtazapine is defined by strict requirements and restrictions documented in official government regulatory sources, such as the FDA and EMA. It is primarily indicated for use in adults (18 years and older).


Absolute Contraindications

Category Official Regulatory Statement
Monoamine Oxidase Inhibitors (MAOIs) Contraindicated in patients taking an MAOI, including linezolid and intravenous methylene blue, or within 14 days of stopping either mirtazapine or an MAOI.
Hypersensitivity Contraindicated in patients with a known allergy or hypersensitivity to mirtazapine or any of the product's excipients.

Age-Related and Conditional Use

Category Official Regulatory Statement
Pediatric Use Not approved for use in pediatric patients (under 18 years of age); safety and efficacy have not been established.
Organ Function Use requires caution in patients with moderate to severe renal or hepatic impairment, as drug clearance is significantly reduced.
Geriatric Use Use in older adults requires caution due to reduced clearance and an increased risk for specific adverse events.
Pregnancy/Lactation Use during pregnancy is permitted only if clearly needed. Caution should be exercised when administered to a nursing woman (breastfeeding).
Specific Comorbidities Caution is advised for patients with a history of seizures, mania/hypomania, or certain cardiovascular risks (e.g., QTc prolongation).

The official eligibility structure is defined by these absolute non-use criteria and a clear age limit, while also establishing constraints for populations with compromised physiological status, requiring mandatory caution and monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Mirtazapine’s interaction profile is officially defined by constraints related to pharmacodynamic load and metabolic capacity, as stipulated in government regulatory documents.

Contraindicated Combinations and Timing Rules

  • Contraindicated Combinations: Mirtazapine is formally contraindicated for co-administration with Monoamine Oxidase Inhibitors (MAOIs), including drugs like Linezolid, due to the documented risk of developing serotonin syndrome.
  • Timing Requirement: A mandatory period of at least 14 days must elapse when discontinuing an MAOI before initiating Mirtazapine, and vice versa.

Pharmacodynamic and Pharmacokinetic Interactions

Interaction Type Interacting Substances Official Outcome Statement
Pharmacodynamic Risk Other serotonergic drugs (e.g., SSRIs, Triptans, St. John's Wort) Increases the documented risk of serotonin syndrome.
Pharmacodynamic Risk CNS Depressants, Alcohol Additive CNS depression, worsening cognitive and motor impairment.
Pharmacokinetic Exposure Strong CYP3A Inhibitors (e.g., Itraconazole, Ritonavir) Officially documented to increase Mirtazapine plasma concentration.
Pharmacokinetic Exposure Strong CYP3A Inducers (e.g., Carbamazepine, Phenytoin) Officially documented to decrease Mirtazapine plasma concentration.

Population and Specific Substance Notes

Official regulatory documentation specifies that Mirtazapine clearance is reduced in patients with established hepatic or renal impairment, resulting in elevated systemic exposure. Caution is also documented when co-administering with medicines that prolong the QTc interval due to increased cardiac risk. The Orally Disintegrating Tablet (ODT) formulation contains aspartame, a source of phenylalanine, relevant for individuals with Phenylketonuria (PKU).

Mechanism of Action

Mirtazapine initiates its core pharmacodynamic action by binding as an antagonist to the presynaptic alpha2-adrenergic autoreceptors and heteroreceptors. This blockade removes the inhibitory negative feedback that typically regulates neuronal activity, promoting a simultaneous release of the neurotransmitters Norepinephrine (NE) and Serotonin (5- HT) into the synaptic space. This mechanism of disinhibition enhances the availability of these signaling molecules, modifying pathways involved in physiological signaling.

Additionally, Mirtazapine acts as an antagonist at specific postsynaptic receptors, particularly the 5- HT2 and 5- HT3 receptor subtypes. This antagonism results in the increased Serotonin being preferentially channeled to the non-blocked mathbf5- HT1 A receptors. This establishes a functional selectivity by bypassing receptor subtypes associated with specific physiological effects.

A key component of its profile is the antagonism at the central Histamine H1 receptors. This targeted pathway interference engages the histamine pathway, resulting in the modulation of the sleep-wake cycle, an inherent physiological consequence of this specific receptor blockade.

Dosage and Administration Information

How to Use Mirtaz

Mirtazapine is administered exclusively by the oral route and is available as film-coated tablets and orally disintegrating tablets (ODT). The medicine should be taken once daily, preferably as a single dose in the evening immediately before sleep, and may be consumed either with or without food. The ODT form requires specific handling: it must be removed from the blister using dry hands, placed on the tongue where it dissolves quickly, and must be swallowed with saliva, without the need for additional water.


Standard Dosing and Adjustment

For adults, the recommended initial starting dose is typically 15 mg once per day. The effective daily maintenance dose generally falls within the range of 15 mg to 45 mg, which is the maximum permitted dose. Any necessary adjustments to the dose must be spaced by an interval of no less than one to two weeks to allow for proper assessment of the response.


Protocol Duration and Discontinuation

Treatment should continue for a sufficient period, often at least six months after the person is deemed symptom-free. When therapy is to be concluded, the medicine must be discontinued gradually via dose reduction, a practice known as tapering.


Population-Specific Usage

The starting dose for older adults may be initiated at a lower level, such as 7.5 mg daily, and closely monitored. Additionally, a dose decrease is required for patients diagnosed with moderate to severe renal or hepatic impairment due to reduced clearance. The medicine is not recommended for use in individuals under 18 years of age.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Mirtazapine (Mirtaz)

This section provides an overview of the official clinical research and study landscape for Mirtazapine, focusing on how the medicine has been evaluated in authoritative government and peer-reviewed scientific sources. The text is strictly descriptive, providing context about the evidence without offering clinical guidance or personal advice.


Evidence for the Acute Treatment of Major Depressive Disorder (MDD)

Studies exploring the use of Mirtazapine are primarily short-term randomized controlled trials (RCTs). This research was conducted during periods of increased symptom activity and applied in studies examining patient-reported experiences related to MDD. These studies monitored adult outpatients and compared Mirtazapine to an inactive placebo or to other active controls, examining outcomes related to systemic or functional imbalance using standardized rating scales.

The studies explored changes measured during the short-term period, typically lasting six to twelve weeks. The findings describe patterns where symptom scores were observed in the Mirtazapine groups when compared to the placebo groups. Other studies monitored outcomes of Mirtazapine against active controls, where the observed patterns were often similar to those controls.

However, certain research limitations apply. The primary evidence is derived from trials with maximum follow-up periods of 12 weeks; long-term clinical outcomes and the sustainability of observed patterns beyond the first year are not fully characterized by controlled studies. Data for certain groups remain insufficient to fully determine the effects on the risks of suicide-related events due to specific limitations in trial design. Evidence highlights what is known—and what is still uncertain—about these short-term effects.


Studies Addressing Associated Symptoms

Sleep Disturbance / Insomnia

Research was conducted in trials assessing short-term or episodic symptom patterns of sleep disturbance that commonly occur with MDD. Studies report how symptoms evolved in the observed populations, indicating that patients receiving Mirtazapine was associated with greater changes in sleep-related factor scores compared to those receiving placebo. Research explored whether the effect was sustained for patients with primary insomnia disorder; one controlled study reported that changes in sleep severity scores were observed to be statistically significant up to six weeks, but the research did not report sustained differences when compared to placebo at later time points.

Appetite Loss / Weight Management

Research examined this medicine in observational settings evaluating daily-life functioning, specifically monitoring outcomes related to physiological strain such as appetite and weight. Some studies report how symptoms evolved in the observed populations, noting that participants receiving Mirtazapine was associated with a change in the frequency of increased appetite and experienced weight gain compared to those receiving placebo. This change is generally observed as an associated physiological event rather than a primary therapeutic target.


What is Still Uncertain About Mirtazapine

Key limitations noted by researchers include that results apply only to the specific populations studied, and the evidence quality varies across studies. Certainty remains low for some long-term outcomes. There is a documented lack of sufficient data regarding the long-term effects of Mirtazapine, and the comparative evidence is lacking for many long-term endpoints.

Key Studies & References

  1. Efficacy of mirtazapine for sleep quality in major depressive disorder: a meta-analysis of randomized controlled trials

Frequently Asked Questions (FAQ)

Common questions about Mirtaz (FAQ)

Q: How does Mirtazapine work in the brain to improve my mood?

A: According to official product information, Mirtazapine is classified as an atypical antidepressant because it modulates specific receptors in the brain. This action leads to the increased availability of key neurotransmitters, specifically Serotonin and Norepinephrine, which are implicated in the regulation of mood. It also blocks receptors associated with specific physiological effects, like the Histamine H1 receptor.

Q: What should I do if I forget to take my Mirtazapine dose?

A: Official instructions suggest taking the missed dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed one should be skipped. It is advised to resume the regular dosing schedule, and two doses should not be taken together to make up for the missed one.

Q: How long does it typically take for Mirtazapine to start working?

A: Clinical trials and official information indicate that observed symptom improvement may begin within the first one to two weeks of starting treatment. However, the full therapeutic effect may take longer to be achieved. Dosing adjustments are often spaced by at least one to two weeks to allow for a proper assessment of the clinical response.

Q: Does Mirtazapine have a potential for dependence or withdrawal symptoms?

A: Official information advises that Mirtazapine is to be discontinued gradually via dose reduction, a process known as tapering. Abrupt cessation of therapy may be associated with discontinuation symptoms, such as dizziness, nausea, headache, or a general feeling of malaise.

Q: Is there a specific time of day I should take Mirtazapine?

A: The official product information states that Mirtazapine is generally taken once daily. Administration is often recommended as a single dose in the evening, immediately before sleep, which is related to its known pharmacological effects.

Q: Can I crush or split the Mirtazapine tablet if I have trouble swallowing it?

A: The film-coated tablet is intended to be swallowed whole. The Orally Disintegrating Tablet (ODT) form is designed to dissolve rapidly on the tongue without needing water; this form is not intended to be split, crushed, or chewed, and should be used immediately after removal from the blister pack.

How should Mirtaz be stored and disposed of?

How to Store and Dispose of Mirtazapine

Storage Requirements

Mirtazapine must be stored at controlled room temperature, specifically between 20°C and 25°C (68°F and 77°F). It must be protected from light and moisture, and kept from freezing. Conventional tablets should remain in their original container and be kept tightly closed. Orally Disintegrating Tablets (ODT) must stay in the blister packaging until the moment of use and should be used immediately after removal.

Child Safety and Disposal

The medication must be stored out of the reach of children. Unused Mirtazapine should not be disposed of by flushing down the toilet. Disposal should follow official guidance, utilizing a drug take-back program if available. If not, the product should be mixed with an undesirable substance and placed in a sealed bag before discarding in the household trash.

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

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