Мелитор

Quick links to important sections

Мелитор

Selected form

Method of action: Antidepressant, Psychoanaleptics

Treatment option:

Medically reviewed

Marina Burgos

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 Мелитор

Quick Facts

Property Description
Active ingredient Agomelatine (INN)
Form Film-coated tablets (25 mg strength)
Pharmacological class Atypical Antidepressant / Other Antidepressant
General purpose Management of Major Depressive Episodes
Origin Synthetic compound (Melatonin analogue)

Мелитор is a prescription-only medicine containing the active ingredient Agomelatine, a synthetic psychotropic agent manufactured and clinically recognized for use in adults experiencing major depressive episodes. It is supplied as a single active ingredient product in the form of film-coated tablets intended for oral administration. The molecule's synthetic origin as an analogue of melatonin is a key differentiating factor in its pharmacological approach.

What Type of Medicine is Мелитор?

Мелитор is categorized as an atypical antidepressant belonging to the pharmacological group of Other Antidepressants (ATC code N06AX22). This classification is based on its mechanism, which is distinctly different from common classes like Selective Serotonin Reuptake Inhibitors (SSRIs).

The molecule’s action combines melatonergic agonist (MT1 and MT2 receptors) properties with a selective 5-HT2C receptor antagonist effect. This dual mechanism is the distinctive factor setting Мелитор apart, offering a strategy focused on neurobiological stabilization rather than primary serotonin modulation.

Composition, Form, and General Purpose

The medicine's composition is centered on Agomelatine combined with necessary pharmaceutical excipients that form the tablet. The general therapeutic purpose is to address the neurobiological disturbances, particularly the disruption of circadian rhythms, frequently observed in patients with depression. Agomelatine exerts its effects through mechanisms distinctly different from many traditional antidepressant treatments. By modulating these systems, Мелитор aims to restore equilibrium and provide symptomatic relief, specifically targeting the improvement of mood regulation and disturbed biological timing associated with the core depressive state.

Regulatory References

  1. EMA Valdoxan (Agomelatine) EPAR Overview
  2. Valdoxan EPAR Summary for the Public

What side effects are possible with Мелитор?

Possible side effects and safety information

The safety profile for Agomelatine (Мелитор) is structured by classifying documented adverse reactions according to frequency, as noted in official regulatory documents. Most adverse reactions are usually mild or moderate and tend to appear within the first two weeks of treatment.

Frequency-Classified Adverse Reactions

Classification Examples of Reactions
Very Common (ge 1/10) Headache
Common (ge 1/100 to < 1/10) Nausea, dizziness, somnolence, insomnia, fatigue, anxiety, abnormal dreams, increased liver enzymes (ALAT/ASAT)
Uncommon (ge 1/1,000 to < 1/100) Migraine, blurred vision, agitation, irritability, pruritus, eczema, weight decreased
Rare (ge 1/10,000 to < 1/1,000) Hallucinations, mania/hypomania, akathisia, hepatitis, jaundice, hepatic failure
Not Known Suicidal thoughts or behaviour

Serious Safety Considerations

The regulatory profile highlights the potential for serious hepatobiliary disorders, including hepatic failure, which has been rarely reported. Elevations of liver enzymes are classified as common and typically occur during the first months of treatment. The label requires routine monitoring of liver function before initiating treatment and periodically during the initial months.

Suicidal thoughts or behaviour are classified as Not Known in frequency and may increase in the early stages of recovery; monitoring is necessary until significant remission occurs. Mania/hypomania is also listed as a rare serious reaction.

Population-Specific Safety Notes

The medicine is contraindicated for use in patients with active liver disease or in those with baseline transaminase levels exceeding three times the upper limit of normal. Use is not recommended in patients 75 years of age and older, and safety has not been established for use in children and adolescents (lt 18 years).

Overdose and Emergency Response

Overdose and When to Seek Help

The documented experience with Agomelatine overdose is limited. The required emergency response involves administering symptomatic and supportive treatment, as official labeling states that no specific antidote is known.

Documented Overdose Manifestations

Overdose manifestations reported in regulatory documentation primarily involve central nervous system and gastrointestinal symptoms. These officially documented presentations include:

  • Somnolence and general fatigue
  • Agitation, anxiety, and dizziness
  • Pain in the upper part of the stomach
  • Cyanosis (blue-ish skin or mucous membrane discoloration)
  • General feeling of being unwell (malaise)

Required Emergency Actions

Following any known or suspected acute overdose, the user is required by official guidance to contact a doctor immediately for medical evaluation.

Official labeling mandates urgent action for signs of potential severe toxicity, particularly the risk of hepatic failure:

  • Treatment must be discontinued immediately if signs of potential liver injury occur (e.g., jaundice, dark urine, pain in the upper right abdomen, or sustained unexplained fatigue).
  • Urgent medical advice must be sought immediately if these signs of severe toxicity develop.
  • If treatment is ceased due to elevated liver enzymes (transaminases exceeding three times the upper limit of normal), regulatory documents require repeated blood tests to monitor the levels until they return to the normal range.

Therapeutic Uses of Мелитор

What Мелитор Treats: Main Uses and Benefits

Melitor is primarily used for the management of Major Depressive Episodes (MDE) in adults, addressing the core emotional components of the condition. This includes the treatment of acute episodes and supporting long-term remission maintenance. The medication helps relieve persistent low mood, feelings of sadness, and emotional instability during acute episodes, providing symptomatic support that contributes to easing the overall symptom load.

A key therapeutic focus involves specifically addressing the pronounced sleep disturbances and disruption of the circadian rhythm often associated with depression. This focus supports improved comfort during periods of heightened symptoms and the regulation of a more natural sleep-wake cycle. The relevant therapeutic applications involve managing symptom clusters related to mood, sleep timing, and motivation.

“The medicine is relevant for easing symptoms that are highly characteristic of a major depressive episode.”

The medication is also applied to address associated symptoms like anhedonia—the loss of interest or pleasure—and low motivation that can cause symptoms that interfere with daily functioning. By helping to reduce the overall symptom burden, it assists with maintaining functional stability. It is relevant for managing symptoms that interfere with daily comfort.

Quick Fact: Relief for Disturbances
This treatment is commonly used across conditions presenting with acute episodes, especially when symptoms related to disrupted biological timing and sleep quality are pronounced.

Regulatory References

  1. Australian Product Information (Valdoxan)

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The eligibility for Agomelatine (Мелитор) is strictly defined by regulatory documents, with absolute exclusions based on liver function and co-administered medications.

Contraindicated Populations (Must Not Use) Age-Related Rules
Hepatic impairment (active liver disease or cirrhosis). Adults Only: Established for patients aged 18 to < 75 years.
Transaminase levels (ALT/AST) exceeding 3 imes ULN at treatment initiation. Not Recommended: Patients under 18 years or aged 75 years and over.
Concomitant use of potent CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin). Not Established: Use is not recommended for elderly patients with dementia.
Hypersensitivity to agomelatine or any excipient.

Condition-Based Restrictions (Caution Required):

The medicine may be used only with caution in patients with moderate to severe renal impairment or a history of bipolar disorder/mania. Caution is also required in individuals with hepatic injury risk factors (e.g., diabetes, obesity, substantial alcohol intake).

Pregnancy and Lactation Status:

Use during pregnancy is preferably avoided due to limited human data. Breast-feeding should be discontinued if the patient is taking the medicine, as it is unknown if the drug is excreted in human milk.

What should I know about interactions with other medicines?

The official regulatory documents define the Agomelatine interaction profile based heavily on its metabolism by the Cytochrome P450 1A2 (CYP1A2) enzyme. This pharmacokinetic interaction establishes mandatory regulatory restrictions and cautions for co-administered medicinal products.

  • Contraindicated Combinations: Co-administration with potent CYP1A2 inhibitors is formally contraindicated. This classification applies to medicines such as the antidepressant Fluvoxamine and the antibiotic Ciprofloxacin. The co-use of Fluvoxamine is documented to result in a marked, approximate 60-fold increase in Agomelatine’s systemic exposure (AUC).

  • Exposure-Modifying Substances: Caution is advised with moderate CYP1A2 inhibitors, including Oestrogens, which cause a several-fold increase in exposure, and medicines like Propranolol and Enoxacin. Agents that induce CYP1A2, such as Rifampicin, may decrease bioavailability. Heavy smoking (over 15 cigarettes per day) is also officially documented as an environmental inducer that reduces Agomelatine exposure.

  • Substance and Cautionary Notes: The combination of Agomelatine and alcohol is not advisable. Official labeling requires caution when combining Agomelatine with other medicines that present a risk of hepatic injury, particularly in patients with pre-existing liver-related risk factors. Official clinical trials found no evidence of pharmacokinetic or pharmacodynamic interaction with medicines such as Benzodiazepines, Lithium, or Paroxetine.

Mechanism of Action

The primary mechanism of Agomelatine involves a highly specific dual interaction with central nervous system receptors, acting as an agonist at the MT1 and MT2 melatonin receptors while simultaneously functioning as an antagonist at the 5-HT2C serotonin receptor. This direct molecular targeting of two distinct receptor families is the foundational step that initiates the resulting physiological effects.

This dual receptor action leads to a synergistic disinhibition of monoamine neurons, effectively removing an inhibitory brake to promote the functional release of Noradrenaline and Dopamine specifically within the frontal cortex. This selective boost to key signaling molecules, combined with the melatonergic action, modulates the activity of neurotransmitter processes.

By activating MT1 and MT2 receptors in the brain's master clock, the drug engages mechanisms that influence biological timing, helping to phase advance and promotes resynchronization of circadian rhythms. This systemic effect on rhythmicity, coupled with enhanced neuroplasticity (BDNF expression), results in altered physiological and cellular activity patterns.

Dosage and Administration Information

Official Administration Guidelines

Мелитор (agomelatine) is supplied as a 25 mg film-coated tablet for oral use and is governed by strict regulatory instructions regarding its administration and monitoring.

Category Official Label Instructions
Route of administration Oral use only. The tablet must be swallowed whole with water, independent of meals.
Dosing schedule The starting and recommended dose is 25 mg once daily. The dose may be increased to the maximum of 50 mg daily only if no improvement is noted after two weeks of use.
Timing in relation to meals May be taken with or without food.
Frequency and Schedule Once daily (q.d.), administered specifically at bedtime (in the evening).
Age-group administration rules No dose adjustment is needed for older adults under 75 years of age. Use is generally not recommended for adults aged 75 years and older.
Missed-dose rules If a dose is missed, the standard instruction is to skip the missed dose and take the next planned dose at the usual time; only one dose must be taken per day.

Procedural Structure

The standard protocol mandates that treatment duration should continue for a minimum of six months after symptom recovery to support long-term stability. The official instruction for discontinuation is that no gradual dosage tapering is required.

Special Procedural Conditions: Administration is tied to mandated procedural monitoring of Liver Function Tests (LFTs). LFTs are required before starting treatment, before any dose increase to 50 mg, and then periodically at specified intervals, including around 3, 6, 12, and 24 weeks during the course of treatment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Мелитор (Agomelatine)

The evidence base for Мелитор (agomelatine) comes from formal clinical research, primarily Randomized Controlled Trials (RCTs). These studies was studied for use in adults experiencing major depressive episodes (MDE), and the results have been synthesized by regulatory bodies and scientific meta-analyses as part of understanding symptom patterns.


Evidence for Acute Treatment of Major Depressive Episodes (MDE)

This section summarizes the structure of the short-term clinical trials used in research exploring how symptoms change over time and the specific scales and measurements relevant in evidence describing how symptoms are measured.

How Acute Trial Findings Were Reported

When the results from numerous acute trials were combined and reviewed (meta-analyses), findings describe patterns observed in the studies over the short term. Research reports indicated a difference in the change of symptom scores favoring the group receiving the medicine over the placebo group.

When studies included active comparators, the measured symptom change was reported as similar to the pattern observed with those treatments. Scientific reviewers have described the magnitude of the measured difference between the medicine and placebo as modest in the context of general antidepressant data. Evidence quality varies across studies, and some analyses have flagged the potential for publication bias, suggesting that not all conducted trials reported equally consistent outcomes.

Research on Long-Term Effect and Relapse Prevention

This part was studied for conditions characterized by fluctuating or episodic manifestations to see how the medicine might be related to symptom recurrence. While one key maintenance study data show patterns related to a longer duration before a relapse occurred for patients continuing the medicine, when the results from all long-term trials were pooled, some analyses reported mixed findings regarding relapse rates. Certainty regarding the long-term prevention of symptom return remains low due to mixed findings and inconsistencies in the data provided.

Understanding Research Gaps and Limitations

This final section synthesizes what regulatory reviews and peer-reviewed meta-analyses have stated about the primary limitations of the current evidence. Findings describe group patterns, not personal outcomes. A key finding is that evidence quality varies across studies, and for long-term use, follow-up durations were limited in some studies, meaning long-term effects are not fully established. Regulatory information notes that the data for certain patient groups, particularly those aged 75 years and older, remain insufficient for documented change in symptoms.

Key Studies & References

  1. A benefit-risk assessment of agomelatine in the treatment of major depression (Critical review including elderly studies and overall efficacy assessment)
  2. Agomelatine in the treatment of anhedonia, somatic symptoms, and sexual dysfunction in major depressive disorder (Study on specific symptom components)

Frequently Asked Questions (FAQ)

Common questions about Мелитор (FAQ)


Q: What is the main difference between Мелитор and standard SSRI antidepressants?

A: The key difference lies in its mechanism of action, according to official information. Unlike standard SSRIs that primarily modify serotonin reuptake, Мелитор stimulates the MT1 and MT2 melatonin receptors while blocking the 5-HT2C serotonin receptor. This dual action is considered distinct from traditional antidepressant classes.


Q: Is Мелитор classified as a habit-forming medicine?

A: Regulatory data indicates that Мелитор does not have documented abuse potential. Furthermore, official instructions state that no gradual dose reduction is necessary when treatment is discontinued, which suggests a low risk of dependence.


Q: How does Мелитор's action on melatonin receptors relate to its effect on mood?

A: The official product information explains that the action on melatonin receptors is designed to help resynchronize the body’s altered circadian rhythms. Since the disruption of these rhythms is often observed in depression, this mechanism is thought to contribute to mood regulation.


Q: How long does it typically take to notice any effect from Мелитор?

A: Official guidelines indicate that the initial dose is reviewed by a doctor after two weeks of use. If no improvement in symptoms is noted by this point, the dose may be adjusted. This two-week period is a key clinical assessment window defined in regulatory instructions.


Q: Do the initial side effects of Мелитор, such as dizziness or nausea, usually go away over time?

A: According to official product information, most adverse reactions are typically mild or moderate and tend to appear within the first two weeks of starting treatment. These effects are generally described as temporary and usually resolve as the treatment continues.


Q: Is it common for people to experience changes in appetite or weight while taking Мелитор?

A: Changes in weight are documented in the safety profile. Specifically, a decrease in weight is listed as an uncommon side effect.


Q: What kind of abnormal dreams or nightmares are sometimes reported with Мелитор?

A: The safety profile lists both abnormal dreams and nightmares as common side effects of the medicine. However, official regulatory summaries do not provide further descriptive detail on the content or nature of these dreams.


Q: Does Мелитор affect sexual function differently than other antidepressants?

A: Clinical studies reviewed by regulatory authorities reported that, when compared to certain other antidepressant treatments, the medicine was associated with the preservation of sexual function.


Q: Why are liver function blood tests required before and during treatment with Мелитор?

A: Liver function blood tests are a mandatory procedural requirement due to the risk of liver injury, which is a serious safety consideration. Regular monitoring is required by official regulations to detect any potential issues early.


Q: What are the possible signs of a liver issue that a patient should be aware of while on this medicine?

A: According to official regulatory documents, symptoms that may suggest a liver issue include dark urine, light-coloured stools, the yellowing of the skin or eyes, pain in the upper right belly area, or sustained, unexplained fatigue.


Q: Are there any specific over-the-counter medicines or supplements that should not be taken with Мелитор?

A: Regulatory guidance advises that patients should inform their healthcare professional about all medicines and supplements they take, including those bought without a prescription. This is necessary because some over-the-counter products may affect the CYP1A2 enzyme, leading to drug interactions.


Q: Is it necessary to avoid alcohol completely while taking Мелитор?

A: Official information states that the combination of the medicine and alcohol is not advisable. This is because alcohol may potentially worsen symptoms of depression and may also cause excessive sleepiness when combined with the medicine.


Q: Is there a known risk of manic episodes for people with a history of bipolar disorder who take Мелитор?

A: Official documents advise that the medicine should be used with caution in individuals who have a history of bipolar disorder, mania, or hypomania. Furthermore, regulatory instructions state that discontinuation is required if a patient develops manic symptoms.


Q: Does Мелитор affect the ability to concentrate or operate machinery?

A: The official product information includes a dedicated section regarding the effects on the ability to drive and use machinery. Due to common side effects such as dizziness and somnolence (sleepiness), official documents contain warnings regarding the need for caution.


Q: Is there evidence of Мелитор helping with anxiety symptoms in addition to depression?

A: The medicine is officially indicated for the management of major depressive episodes. Regulatory documents note that anxiety is one of the associated symptoms of depression that the medicine is used to treat.


Q: Why does Мелитор have different drug interactions compared to an SSRI or SNRI?

A: The unique drug interaction profile is based on how the body processes the medicine. Official documents state that it is primarily metabolized by the CYP1A2 enzyme, which is a different metabolic pathway than the primary metabolism of many common SSRI and SNRI antidepressants.


Q: What is the risk of withdrawal symptoms when discontinuing Мелитор?

A: According to official regulatory instructions, no gradual dosage tapering is required when the medicine is stopped. This procedural instruction suggests a low likelihood of experiencing discontinuation or withdrawal symptoms.


Q: What is meant by the drug class 'melatonergic antidepressant'?

A: This term describes the drug’s dual mechanism of action, which is distinct from many other antidepressants. It involves stimulating the MT1 and MT2 melatonin receptors while simultaneously blocking the 5-HT2C serotonin receptors.


Q: What are the symptoms of an overdose of Мелитор?

A: Official regulatory information reports that symptoms observed following an overdose have included sleepiness, fatigue, anxiety, and agitation. Other reported symptoms are dizziness, tension, upper stomach pain, cyanosis (blue discoloration), and general discomfort.


Q: Does Мелитор cause gastrointestinal side effects like constipation or diarrhea?

A: Official documents list both diarrhoea and constipation among the common gastrointestinal side effects associated with the medicine.


Q: Can Мелитор be safely used with common pain relievers or cold medicines?

A: Official documents highlight the need for caution with co-administration of any medicine that can affect the CYP1A2 pathway. Since some common cold or pain relief medicines contain ingredients that interact with this enzyme, patients are advised to disclose all medicines to their prescriber.


Q: Are there any known effects of Мелитор on blood pressure or heart rate?

A: Data from clinical trials reported in regulatory risk management plans indicate that the medicine had a neutral effect on both heart rate and blood pressure.


Q: How quickly must a patient report signs of potential liver problems?

A: If a patient develops symptoms or signs that suggest potential liver injury, official regulatory instructions state that discontinuation is required immediately and contacting the prescribing physician without delay is advised.


Q: Is a change in sleep pattern (like feeling sleepy during the day) an expected initial effect?

A: Sleepiness (somnolence) and fatigue are listed as common side effects. Since most adverse reactions tend to appear within the first two weeks of treatment, these effects may be noted in the initial phase.

How should Мелитор be stored and disposed of?

How to Store and Dispose of Melitor (Agomelatine)

Official regulatory information defines specific environmental and packaging requirements necessary to maintain the integrity of Melitor tablets.


Storage Requirements

Constraint Official Requirement
Temperature Does not require any special temperature storage conditions.
Protection Must be stored in the original package to protect from moisture.
Stability Labeled shelf life is 3 years (in original, unopened packaging).

Disposal Instructions

For unused or expired Melitor, disposal must adhere strictly to local regulations. Regulatory documents indicate that the product has no special requirements for disposal beyond the obligation to discard all unused medicinal product or waste material in accordance with local requirements for pharmaceutical waste.

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

Available in countries:

Equivalent of Мелитор found in:

A-Z Index: