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Миасер

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Миасер

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Method of action: Antidepressant

Treatment option:

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.

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Overview of Миасер

What is Миасер? (Mianserin)

Property Description
Active ingredient Mianserin hydrochloride (INN: Mianserin)
Form Film-coated tablets (Oral)
Pharmacological class Antidepressant; Specific Noradrenergic and Serotonergic Antidepressant (NaSSA)
General purpose Alleviating symptoms of depressive illness
Origin Synthetic, Tetracyclic compound

What Type of Medicine is Миасер?

Миасер is a prescription-only medicine whose active component is the substance Mianserin hydrochloride, which is classified as an antidepressant. The drug is structurally identified as a synthetic tetracyclic compound belonging to the piperazinoazepine derivative group.

Its specific mode of action has earned it the classification of a specific noradrenergic and serotonergic antidepressant (NaSSA), a unique group defined by targeted receptor antagonism rather than general reuptake inhibition. This designation highlights its differentiating feature: it modulates noradrenaline and serotonin activity through targeted receptor blocking, providing a distinct pharmacological profile for the treatment of depressive illness.

Composition, Form, and General Purpose

Миасер is supplied as a single-ingredient product in the form of film-coated tablets intended for oral administration. The composition includes Mianserin hydrochloride as the active substance and standard inert solid excipients, ensuring stable and reliable delivery within the body.

The overall goal of using this medication is to alleviate the general symptoms associated with depressive illness in adults. The drug exerts its therapeutic effect by modulating the levels and activity of key neurotransmitters. Furthermore, Mianserin's strong H1-histamine receptor antagonism is a key differentiating feature, contributing to its ability to concurrently address common symptoms like sleep disruption when depression is accompanied by significant insomnia.

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What side effects are possible with Миасер?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse reactions and safety risks for Miссер (mianserin), as classified in authoritative government regulatory documents.

Frequency-Classified Adverse Reactions

The safety profile is structured by the frequency of reported adverse events:

  • Very Common (Affecting more than 1 in 10 people): Drowsiness (especially at the start of treatment), dry mouth, and constipation.
  • Common (Affecting up to 1 in 10 people): Ongoing drowsiness, tremor, headache, dizziness, vertigo, and weakness. Weight gain has also been reported as common or uncommon.
  • Rare and Very Rare: These reports include severe events like agranulocytosis (a serious reduction in white blood cells), bone marrow depression, seizures (convulsions), liver dysfunction (jaundice, hepatitis), and heart rhythm abnormalities (such as QTc prolongation and Torsade de pointes).

Serious Safety Risks and Contraindications

Regulatory agencies highlight specific serious risks requiring immediate attention:

  • Hematological Risk: A severe reduction in white blood cells (agranulocytosis) is a known, rare risk, often occurring 4–6 weeks into treatment. Any sign of infection, such as fever or sore throat, warrants immediate evaluation.
  • Suicide Risk: An increased risk of suicidal thoughts, self-harm, and hostility is documented, particularly in children, adolescents, and young adults (up to 25 years old). Close supervision is required during early treatment and following dose changes.
  • Discontinuation Syndrome: Stopping the medication abruptly can lead to withdrawal symptoms, including dizziness, anxiety, nausea, and headache.
  • Contraindications: The use of Miссер is prohibited in patients with severe liver disease, during periods of acute mania, and in cases of known hypersensitivity to the substance.

Population and Organ System Safety Notes

Caution is advised for specific patient populations and existing conditions:

  • Pediatric Use: The medication is generally not recommended for use in children and adolescents under 18 years of age due to safety concerns, including the increased risk of suicide-related events.
  • Metabolic and Cardiac Effects: Safety documentation notes the potential for metabolic changes, including elevated cholesterol, triglycerides, and effects on glucose tolerance, particularly in diabetic patients. Caution is also necessary for patients with pre-existing heart conditions or a history of seizure disorders.
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Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Mianserin requires immediate contact with emergency medical services or a doctor. The drug container and any remaining tablets should be brought to the emergency department for reference in management.

Overdose manifestations documented in regulatory sources primarily involve Central Nervous System (CNS) depression. Symptoms commonly seen include prolonged sedation, drowsiness, confusion, and an altered state of consciousness. However, severe and potentially life-threatening outcomes have been reported, necessitating urgent medical care.

These severe outcomes include serious effects on the cardiovascular system, such as hypotension (low blood pressure) and cardiac arrhythmias. Neurological complications such as convulsions and progression to coma are also officially listed risks.

Management is restricted to symptomatic and supportive therapy, as no specific antidote is known for Mianserin overdose. Continuous monitoring, especially of cardiac function and vital signs, is required during hospitalization. Overdose severity may be heightened when the medication is taken in combination with other substances (polypharmacy).

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Therapeutic Uses of Миасер

What Миасер treats: main uses and benefits

This medication is commonly used to help manage the symptomatic burden across conditions characterized by periods of heightened symptoms. It is relevant in conditions involving core emotional symptoms, such as pervasive low mood and distress, and provides support that assists with maintaining functional stability.

The medicine is indicated for treating primary depressive illness, including specific forms like endogenous depression and reactive depression. It is commonly used in situations where symptoms that interfere with daily functioning, such as anxiety or insomnia, are present. The medication plays a role in managing symptom clusters that include insomnia and anxious tension, which are frequently associated with depression. This offers symptomatic relief that helps patients cope more steadily with difficult episodes.

It is considered relevant when supportive symptom management is appropriate and may be part of symptomatic management in contexts involving acute or disruptive symptom patterns when additional symptomatic support is needed. The medication is also utilized for easing symptoms in specific groups, such as older adults and those with stable cardiovascular conditions.


Quick Fact Relief for
Primary Focus Depressive Symptoms (low mood, distress)
Secondary Focus Sleep Disturbance (insomnia, anxious tension)
Contextual Use Symptom Augmentation (support in complex cases)

Regulatory References

  1. Mianserin SPC
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Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Mianserin

Official regulatory documents define strict criteria for Mianserin eligibility, classifying use as allowed, restricted, or absolutely contraindicated in specific patient populations.

Eligibility scope Classification in Official Labeling
Populations for whom use is allowed Adults (18 years and older) for the treatment of primary depressive illness. Use in Older Adults is generally acceptable, though requires close supervision.
Populations for whom use is contraindicated Patients with known hypersensitivity to mianserin, those in a manic phase, or patients with severe liver disease. Use during pregnancy and lactation is also contraindicated/not recommended [1.1, 2.2].
Age-related eligibility rules Not Recommended for use in children and adolescents under 18 years of age. Safety and long-term efficacy are not established in this pediatric population [1.6, 2.2].
Condition-specific eligibility rules Caution is required for patients with epilepsy, cardiac disturbances (e.g., heart block), diabetes mellitus, and mild to moderate hepatic or renal impairment [1.1, 1.4].

Official eligibility statements:

  • The medicine is contraindicated in patients with a history of mania, severe liver disease, or known hypersensitivity to the drug [1.1, 2.2].
  • Use is not recommended for children and adolescents under 18 and is contraindicated for pregnancy and lactation [2.2, 3.4].
  • Special caution and monitoring are mandated for patients with epilepsy or various cardiac conditions [1.1, 1.4].

Connection to the overall eligibility profile: Regulatory documents designate Mianserin for use exclusively in adults who do not have any of the documented absolute contraindications. Eligibility is restricted by mandates for caution in populations with pre-existing organ or systemic conditions, and the medicine is officially not recommended for those under 18 or in reproductive stages [2.2, 2.4].

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of Mianserin (Миасер) based on two primary domains: pharmacodynamic potentiation and pharmacokinetic (PK) metabolic effects.


Formal Restricted and Contraindicated Combinations

Co-administration with Mono Amine Oxidase Inhibitors (MAOIs) is a formally restricted combination. Mianserin must not be started within two weeks of stopping MAOI therapy. Conversely, an MAOI such as Moclobemide should not be started until at least one week after Mianserin administration is discontinued.

Exposure-Modifying and Pharmacodynamic Interactions

  • Enzyme Inducers: Agents like Carbamazepine and Phenobarbital accelerate the metabolism of Mianserin, resulting in a documented reduced plasma concentration of the drug.
  • CNS Depressants: Mianserin may potentiate the central nervous depressant action of alcohol, anxiolytics, hypnotics, and antipsychotics.
  • Anticonvulsants: Mianserin may antagonize the anticonvulsant effect of certain antiepileptics by potentially lowering the seizure threshold.
  • Anticoagulants: Concurrent use with coumarin-type anticoagulants (e.g., Warfarin) is permissible but necessitates that close additional monitoring procedures be carried out.

Regulatory labels require that patients avoid alcohol during treatment due to its ability to potentiate the central nervous depressant action of Mianserin. For patients with hepatic or renal insufficiency, normal regulatory precautions should be exercised, and dosages of any concurrent therapy should be kept under review.

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Mechanism of Action

Dual Disinhibition of Noradrenaline and Serotonin Pathways

Mianserin's primary action is the antagonism of presynaptic alpha2-adrenergic autoreceptors, which functionally removes the inhibitory negative feedback loop on neurons, leading to the disinhibition and increased release of Noradrenaline and Serotonin. This targeted blockade initiates the slow, long-term process of modulating key monoamine systems involved in the regulation of central monoamine pathways.


High-Affinity Central Histamine Suppression

The drug exerts a separate, rapid-onset mechanism through its high-affinity antagonism of the Histamine H1 receptors in the brain. This action directly suppresses central histaminergic transmission, which is crucial for maintaining alertness. This domain leads to the immediate physiological consequence of reduced central arousal and supports a state of decreased physiological alertness.


Postsynaptic Serotonin Receptor Modulation

Mianserin also targets and blocks specific postsynaptic Serotonin 5-HT2 A and 5-HT2 C receptors. This antagonism functionally enhances the signaling of other Serotonin receptors ( 5-HT1), resulting in altered dynamics of the serotonergic system and contributing to the long-term adaptation of neural circuits.

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Dosage and Administration Information

How to use Миасер

Миасер is strictly for oral administration and is supplied as a film-coated tablet. The tablet must be swallowed whole with fluid and must not be chewed. The total daily dose can be taken either in divided portions or as a single dose. Due to the medication’s properties, the single dose is often administered at night.

The use protocol begins with an initial adult daily dose, typically 30 mg or 40 mg. This is followed by a period of titration where the dosage is gradually increased based on the patient’s response. The established maintenance regimen usually ranges between 30 mg and 90 mg per day, with doses up to 120 mg daily. Once the effective dose is reached, treatment should be maintained for several months to ensure the desired duration of effect. If a regular dose is missed, it is advised not to take a double dose to compensate.

Specific considerations apply to various patient populations. For older adults, the starting dose should not exceed 30 mg daily, and subsequent dose increases must be slow and closely supervised, often resulting in a lower long-term maintenance dose. The use of this medicine is not recommended in children and adolescents under the age of 18 years.

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Recent Clinical Evidence

Research evidence / Overview of Studies for Миасер

This section summarizes the published research regarding Mianserin (Miaser), focusing on the types of studies conducted, the outcomes researchers measured, and the limitations or gaps that remain in the current evidence landscape. The information here describes what has been observed in study populations and does not constitute individual medical advice.


Evidence for Use in Major Depressive Disorder (MDD)

Research for MDD primarily involves short-term, controlled clinical trials, some of which compare Miaser against an inactive treatment (placebo) or other standard treatments. These studies have been used in research exploring how symptoms change over time in adult patients with depression. Researchers typically measured changes in depressive symptoms using standardized clinical rating scales. Studies monitored changes in symptom scores during the short-term follow-up.

A key consideration is that the majority of these acute-phase studies date back several decades. This means the results apply only to the populations studied under the diagnostic criteria and treatment contexts of that time. Evidence contributes to understanding symptom patterns, but it does not determine whether an individual will respond similarly today.


Research on Use in Treatment-Resistant Depression

Research has also evaluated Miaser in the context of treatment-resistant depression (TRD), where symptoms have not fully responded to a prior antidepressant treatment. The available evidence includes Randomized Controlled Trials (RCTs) that explored strategies such as adding Miaser to an existing antidepressant (augmentation) or switching entirely to Miaser.

For augmentation, research monitored observations related to daily functioning when Miaser was added compared to continuing the original treatment. Conversely, for the strategy of switching entirely to Miaser, findings were mixed; studies described patterns where the symptom scores following the switch to Miaser were observed to be similar to scores in patients who continued the previous antidepressant treatment.


What is Still Uncertain About Miaser Evidence

Research to date leaves several gaps. What remains uncertain includes the full long-term profile of Miaser, as long-term effects are not fully established because follow-up durations were limited in many of the primary controlled trials. Also, direct comparisons of Miaser to many newer treatments are limited, meaning comparative evidence is lacking. The evidence highlights what is known—and what is still uncertain about Miaser.

Key Studies & References

  1. Mianserin prevention of depression and functional deficits after stroke: a randomized, double-blind, placebo-controlled trial
  2. NICE Guideline: Depression in adults: treatment and management (General Contextual Guideline)
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Frequently Asked Questions (FAQ)

Common questions about Миасер (FAQ)


Q: What is the typical starting dose for a healthy adult?

According to official prescribing information, treatment with Mianserin usually begins with a starting dose of 30 mg or 40 mg per day. This initial dosage is followed by a period of gradual adjustment to find the optimal effective dose, which commonly falls between 30 mg and 90 mg daily. The precise dosage and any necessary adjustments are determined by the treating healthcare provider.


Q: Will Миасер make me gain weight?

Official regulatory documents acknowledge that weight gain has been reported as an undesirable effect of Mianserin. This change is classified in safety data as a common or uncommon occurrence. Concerns about weight changes or any other side effect should be discussed with a healthcare professional.


Q: How long does it take for the antidepressant effect to start working?

Clinical studies often report that antidepressant effects may become noticeable after one to three weeks of treatment, though individual response times can vary. Like many other medicines in this class, Mianserin works through a slow, long-term process of modulating key neurotransmitter systems.


Q: Can Миасер interact with Warfarin or other blood thinners?

Yes, regulatory documentation states that concurrent use of Mianserin with coumarin-type anticoagulants, such as Warfarin, may alter their effects. When these medicines are used together, close additional monitoring procedures of the patient's blood clotting are mandated by official guidelines.


Q: Does this medicine affect heart rhythm, like QTc?

Official safety data lists heart rhythm abnormalities as a rare or very rare potential side effect of Mianserin. These can include conditions like QTc prolongation and Torsade de pointes. For patients with pre-existing heart conditions, official guidelines advise special caution and monitoring by a healthcare provider.


Q: What specific foods or supplements should I avoid while taking Миасер?

Official product information advises against the consumption of alcohol due to its potential to increase the central nervous depressant action of Mianserin. Beyond alcohol, no specific foods or non-alcoholic supplements are routinely listed in the main regulatory documents as mandatory to avoid.


Q: Is it safe to drive or operate heavy machinery while on this medication?

Official information indicates that drowsiness is a common side effect, especially when starting treatment. Official guidelines state that due to the risk of drowsiness, patients are warned of the possible hazard when performing tasks that require full concentration, such as driving or operating machinery.


Q: Can Mianserin be safely taken during pregnancy or while breastfeeding?

Mianserin is generally not recommended for use during pregnancy, and its administration is based on the prescribing professional's assessment of potential risks versus benefits. Official guidance indicates that use during breastfeeding is contraindicated, and if treatment is considered necessary, cessation of breastfeeding is advised to avoid exposure to the infant.

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How should Миасер be stored and disposed of?

How to Store and Dispose of Miaser (Mianserin Hydrochloride)

Official regulatory labeling dictates strict conditions for the storage and disposal of Miaser tablets to ensure stability and proper waste management.

Storage Requirements

The medicine must be stored at a temperature not above 30°C. It is mandatory to keep Miaser in its original package to ensure it is protected from both light and moisture. For safety, the product must always be stored out of the sight and reach of children.

Condition Requirement
Temperature Store below 30 C
Protection Protect from light and moisture
Child Safety Keep out of sight and reach of children

Disposal Instructions

Unused or expired Miaser must not be disposed of via household waste or wastewater. The product should be discarded in accordance with local pharmaceutical requirements. Patients are instructed to return unwanted medicine to the pharmacy for appropriate disposal.

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

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