Адаптол

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Адаптол

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Method of action: Tranquilizing

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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 Адаптол

Property Description
Active Ingredient Tetramethyltetraazabicyclooctandione (Temgicoluril)
Form Tablets (Oral)
Pharmacological Class Anxiolytic (Non-benzodiazepine tranquilizer)
General Purpose Emotional stabilization, reduction of anxiety and tension
Origin Synthetic

What Type of Medicine is Адаптол and What Does it Contain?

Адаптол is an anxiolytic agent, classified as a non-benzodiazepine tranquilizer, primarily used for emotional stabilization. Its active component is the synthetic compound Tetramethyltetraazabicyclooctandione, internationally recognized as Temgicoluril.

This medication is a single-component preparation supplied as tablets for oral use. The structural difference from traditional benzodiazepine tranquilizers defines its unique pharmacological class. The chemically equivalent entity is known commercially as Mebicar, which shares the same active substance. Адаптол is notably associated with production in the Baltic region for various Eastern European markets, where it has an established pharmacological presence.


What is the General Purpose of This Anxiolytic Agent?

The general purpose of Адаптол is to alleviate symptoms of internal emotional tension, chronic anxiety, and fear by modulating the brain's emotional centers, thereby achieving emotional equilibrium. The substance is intended for the management of symptoms of restlessness and irritability.

A key benefit of this anxiolytic is its capacity to reduce unrest while preserving normal cognitive function, alertness, and motor coordination. It selectively influences neurotransmitter activity, supporting emotional balance without significant sedative effects, muscle relaxation, or functional impairment associated with some other tranquilizer classes. This profile enables its use during periods requiring maintained intellectual and professional activity, a distinguishing factor in its clinical positioning.

What side effects are possible with Адаптол?

Possible Side Effects and Safety Information

The official safety profile for Адаптол (Temgicoluril) is documented based on regulatory standards, classifying the primary documented adverse events.

Adverse Reaction Classification

Adverse reactions listed in the official prescribing information are typically classified as Rare, meaning they affect less than 1 in 1,000 patients. These effects are grouped into several System-Organ Classes:

  • Vascular Disorders: May include low blood pressure (hypotension).
  • Nervous System Disorders: May manifest as dizziness and general weakness.
  • Gastrointestinal Disorders: Occasional indigestion.
  • General Disorders: Includes a decrease in body temperature (hypothermia).
  • Skin and Immune Disorders: Primarily allergic reactions, such as skin itch, which are noted as possible after the administration of high doses.

Safety Considerations and Restrictions

Official regulatory documents contain specific safety notes:

Consideration Regulatory Statement
Pediatrics & Pregnancy Not recommended for use in children under 18 years of age, or during pregnancy and lactation.
Functional Safety The effects of weakness and hypotension may impair the ability to drive or operate machinery.
Exposure Pattern Changes in blood pressure and body temperature are documented to normalize after treatment completion.
Dependence The regulatory profile includes a statement that no tolerance, drug dependence, or withdrawal syndrome has been observed in clinical studies.

In the event of an allergic reaction, regulatory guidance states that the medicine should be discontinued. These regulatory classifications define the medicine's risk profile, focusing on rare physiological and functional effects.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented overdose profile for Tetramethyltetraazabicyclooctandione (Temgicoluril), based strictly on government regulatory agency documentation.


Overdose Manifestations and Required Actions

The regulatory documentation indicates that the substance has a low acute toxicity profile, suggesting that severe outcomes are not expected. Overdose is primarily associated with mild, non-severe symptoms.

Officially documented clinical signs may include a decrease in vital functions, specifically hypotension (decreased blood pressure) and hypothermia (decreased body temperature).

Urgent Medical Attention: Individuals must seek medical attention or contact emergency services if symptoms are persistent, severe, or worsening, particularly when accompanied by symptomatic hypotension.


Management and Monitoring

No specific antidote is known for intoxication with this compound, a statement explicitly included in official regulatory summaries. Consequently, the mandated intervention for overdose is symptomatic and supportive therapy, coupled with general detoxification measures.

Hospital monitoring may be required to manage supportive care. Regulatory guidance specifically mandates continuous monitoring of blood pressure due to the identified risk of hypotension. Gastric lavage may be necessary following recent, massive ingestion of the tablets.

Therapeutic Uses of Адаптол

This medication is commonly used to help with symptoms related to psychological stress and tension. The compound is grouped within a category addressing psycholeptic and neurological function. It is used for managing conditions characterized by heightened emotional intensity, such as neurotic states and generalized anxiety disorders, and may assist with symptoms related to persistent inner tension, irritability, and feelings of unrest.

The medication is also considered relevant for easing symptom clusters linked to autonomic dysfunction, where physical discomfort, like non-cardiac chest discomfort (cardialgia) and palpitations, may interfere with daily comfort. In complex therapeutic regimens, it is applied as supportive symptom management during the process of nicotine abstinence and is relevant in settings where short-term symptom stabilization is important.

“The primary goal of this supportive medication is to help patients cope more steadily with symptom fluctuations and maintain a sense of stability when symptoms are more noticeable.”


Symptom Focus: Inner Tension and Autonomic Imbalance

This compound is relevant in clinical settings that involve symptomatic discomfort from both psychological distress (anxiety, irritability) and the physical symptoms (palpitations, chest tension) that stem from stress, and may assist with maintaining functional stability.

Eligibility and Restrictions for Use

Who Can and Cannot Use Адаптол?

This section details the population eligibility and restrictions for Адаптол (Tetramethyltetraazabicyclooctandione or Temgicoluril) as defined by regulatory documents. The information strictly covers who is permitted to use the medicine, who is prohibited, and under what conditions use is limited.


Regulatory Eligibility Status

Population Group Eligibility Status Regulatory Basis
Adults (18+ years) Permitted Primary eligible population
Children & Adolescents (<18) Not Recommended Safety and efficacy not established
Pregnancy/Lactation Not Recommended Insufficient clinical safety data
Hypersensitivity Contraindicated Absolute prohibition

Conditional Use and Restrictions

Use of Адаптол is contraindicated for any individual with a known hypersensitivity to the active substance, Temgicoluril, or its excipients. This represents the only absolute exclusion defined in the official labeling. The medicine is not recommended for the pediatric population (under 18 years) because its safety and efficacy in this age group have not been established by regulatory bodies. Similarly, due to a lack of sufficient clinical safety data, use is not recommended during pregnancy or while breastfeeding.

For patients with renal impairment (kidney failure), caution is advised, as formal studies regarding dose adjustments for this condition have not been conducted. Conversely, no dose adjustment is required for the elderly population or for patients with hepatic impairment (liver failure), suggesting permitted use under standard conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Tetramethyltetraazabicyclooctandione (Adaptol) is primarily defined by documented pharmacodynamic potentiation when co-administered with other centrally acting agents. The prescribing information confirms the following interaction patterns.

Drug–Drug and Drug–Substance Interactions

Co-administration with other tranquilizers (including benzodiazepines), hypnotics, antidepressants, or neuroleptics may result in an additive effect or potentiation of their central nervous system (CNS) actions. This pharmacodynamic effect is a key consideration when combining this medicine with other psychotropic agents.

Interaction with alcohol (ethanol) is strictly restricted, as the concomitant use of alcoholic beverages is documented to intensify the medicine's effects on the nervous system.

Other Interaction Considerations

The medicine's administration is documented to be independent of food intake. There is no official documentation of a clinically significant drug–drug interaction involving metabolic enzymes (like CYP450) or drug transporters, and regulatory documents do not specify mandatory timing separation rules for co-administration.

Specific cautions are noted for patients with renal impairment, as comprehensive interaction data regarding kidney function are not fully studied in this population, suggesting that the relevance of interactions may differ.

Mechanism of Action

The substance, Tetramethyltetraazabicyclooctandione (Temgicoluril), modulates several signaling systems in the central nervous system (CNS). Its mechanism involves enhancing inhibitory GABA (gamma-aminobutyric acid) activity while concurrently adjusting the balance of monoamines by increasing Serotonin and decreasing Norepinephrine. This focused activity on neural pathways regulating excitability is characterized by a lack of significant functional interaction with CNS components that specifically govern profound sedation or muscle tone.

The mechanism involves the modulation of the hypothalamic and limbic-reticular systems, which are central structures for processing emotional reactivity. By modulating signaling within these areas, the substance alters the sequence of molecular steps associated with heightened emotional arousal. This modulation alters the physiological expression of heightened emotional states.

The substance's action also influences the body's stress regulatory pathway. The mechanism attenuates the stress-induced elevation of circulating corticosterone and decreases the associated secretion of certain proinflammatory cytokines. This systemic stabilization modulates the physiological expression (somatic manifestations) associated with central excitability.

Dosage and Administration Information

Administration Guidelines for Адаптол (Temgicoluril)

This section describes the administration parameters for the anxiolytic agent Адаптол.


Administration Scope

Usage Parameter Standard Parameters
Route of Administration Oral only (tablets or capsules).
Standard Adult Dose Typically 300 mg to 500 mg per administration.
Frequency Generally 2 to 3 times daily.
Timing with Meals Permitted independently of food intake.
Maximum Dosing Highest single dose: 3 g (3000 mg). Highest daily dose: 10 g (10,000 mg).
Duration of Use Treatment courses range from a few days up to 2 to 3 months, with specific supportive protocols (e.g., 5 to 6 weeks for nicotine cessation support).

Population and Procedural Rules

The standard guidelines outline specific rules for various patient groups and administration procedures:

  • Age-Group Rules: Use is not recommended for children and adolescents under 18 years of age.
  • Organ Function: No specific dose reduction is mandated for older adults or patients with liver impairment.
  • Missed Dose: A forgotten dose should not be compensated for by doubling the subsequent administration; the patient should simply continue the treatment schedule with the next regular dose.
  • Tablet Handling: The break-mark on the 500 mg tablet is provided solely to aid in swallowing and is not intended for dividing the dose into exact halves.

These protocols define the routine use of the drug, encompassing the route, frequency, and dose limits.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Адаптол

Evidence for Neurosis, Anxiety, and Emotional Tension Studies

Research has examined the compound through Randomized Controlled Trials (RCTs), alongside various Observational Studies, in adult populations used in research exploring how symptoms change over time, particularly those experiencing mild-to-moderate anxiety and internal emotional tension. Studies were designed to measure outcomes related to systemic or functional imbalance, specifically looking at changes measured in standardized anxiety rating scales and patient-reported assessments of inner tension, fear, and irritability. This research primarily focuses on short-term or episodic symptom patterns over periods typically lasting a few weeks to a few months.

The findings from these studies describe patterns observed in the observed populations, reporting changes measured in scores for anxiety and tension. Research examined the medicine's influence on functional outcomes, such as alertness and cognitive function, with some studies describing patterns of non-impairment in these areas as measured against specific comparator conditions. These findings provide insight into symptom patterns in individuals with neurotic states.

Evidence for Autonomic Dysfunction and Psychosomatic Symptoms

This part reviews the research involving individuals with physical discomforts related to stress, such as non-cardiac chest discomfort (cardialgia) and palpitations, describing the specific studies that examined these psychosomatic symptom clusters, often within complex therapeutic regimens.

Studies described patterns where the compound's use was associated with concurrent changes measured in both the emotional state and the physical symptom profile. However, because the medicine was evaluated in complex, combined therapy settings, precisely determining the independent influence of the compound on the somatic symptoms may be uncertain.

Long-Term Studies and Follow-up Durations

The majority of studies conducted on this compound utilize follow-up durations [that] were limited, typically reporting outcomes over periods of a few weeks up to approximately three months. Consequently, long-term effects are not fully established, and there is limited information for long-term outcomes regarding the maintenance of stability or the potential for symptom return over extended periods.

Frequently Asked Questions (FAQ)

Common questions about Адаптол (FAQ)


Q: Why do some people say Адаптол helps with anxiety?

A: Official regulatory documents classify this medication as an anxiolytic agent. Its general purpose, as described in official documents, is the emotional stabilization and the reduction of symptoms of internal tension, fear, and chronic anxiety. This effect is achieved by modulating certain centers in the brain that process emotional reactivity.


Q: What are the most commonly reported side effects of Адаптол?

A: Official prescribing information generally classifies documented adverse reactions as Rare, meaning they are reported to affect less than 1 in 1,000 patients. These rare effects include symptoms like dizziness, general weakness, occasional low blood pressure, and temporary decreases in body temperature. The official documentation does not specify which of these rare effects is the most frequent.


Q: Is it normal to feel slightly dizzy when starting Адаптол?

A: Dizziness is documented in regulatory sources as a Rare side effect of the medicine. While there is no specific statement that addresses dizziness only upon starting treatment, dizziness and weakness are documented as possible rare adverse events.


Q: Can Адаптол be used to manage irritability?

A: Official documentation supports that the general purpose of the medicine is to manage symptoms of internal emotional tension, which includes restlessness and irritability. Research evidence has also examined the compound in studies looking for changes in patient-reported assessments of irritability.


Q: What does official research say about the effectiveness of Адаптол?

A: Official research and studies have examined the compound in adult populations experiencing mild-to-moderate anxiety and internal emotional tension, often through Randomized Controlled Trials. The findings describe patterns observed in these studies, reporting measured changes in patient scores for anxiety and tension symptoms. These findings help provide insight into the medicine's role in managing neurotic states.


Q: What happens if I forget to take a dose of Адаптол?

A: According to official administration guidelines, a forgotten dose should not be compensated for by doubling the subsequent administration. Regulatory guidelines advise that treatment should simply continue with the next regular dose.


Q: Can I take Адаптол if I have an existing mental health condition?

A: Regulatory documents confirm that co-administration with other psychotropic agents—such as tranquilizers, hypnotics, or antidepressants—may result in an additive effect or potentiation of their central nervous system actions. Co-administration may result in an additive or potentiation of CNS effects, which is a key consideration when the medicine is used.


Q: How quickly can I expect to notice any effects from Адаптол?

A: Official sources do not define a precise timeframe for the onset of subjective, noticeable effects. However, the substance is documented to be rapidly absorbed and quickly cleared from the body.


Q: Is Адаптол known to cause dependence or withdrawal symptoms?

A: The regulatory safety profile includes a specific statement that no tolerance, drug dependence, or withdrawal syndrome has been observed in clinical studies associated with this medicine.


Q: Are there any serious or rare side effects associated with Адаптол?

A: Reported adverse reactions are officially classified as Rare, meaning they occur in less than 1 in 1,000 patients. These rare effects include low blood pressure, dizziness, weakness, temporary decrease in body temperature, and allergic reactions. In the event of an allergic reaction, regulatory guidance states the medicine should be discontinued.


Q: Can Адаптол be used by people with low blood pressure?

A: Low blood pressure, or hypotension, is listed in official documents as a rare possible side effect of the medication. Pre-existing low blood pressure is not documented as an absolute contraindication, but potential users should be aware of this known effect.


Q: Does Адаптол affect sleep patterns?

A: A distinguishing factor noted in official documents is the medicine's capacity to reduce emotional unrest while importantly preserving normal cognitive function and alertness. It is not associated with the significant sedative effects or muscle relaxation seen with some other tranquilizer classes.


Q: Can people with kidney problems take Адаптол?

A: For patients with renal impairment (kidney failure), official guidance states that caution is advised. This caution is advised because formal studies regarding dose adjustments for this specific condition have not been conducted.


Q: Is there a risk of allergy when taking Адаптол?

A: Yes, official labeling notes that use is contraindicated (absolutely prohibited) for any individual with a known hypersensitivity to the active substance or its inactive ingredients. Allergic reactions, such as skin itch, are also documented as a rare possible adverse event.


Q: What is the maximum duration of treatment usually described in official sources?

A: The treatment courses described in regulatory documents vary but typically range from a few days up to a maximum of two to three months.


Q: Are there different strengths of Адаптол tablets?

A: Official administration guidelines reference standard doses ranging from 300 mg to 500 mg per administration. This indicates that the medicine is commercially available in different tablet strengths.


Q: Why do official sources categorize Адаптол as an anxiolytic?

A: The medicine is categorized as an anxiolytic agent due to its pharmacological profile. The categorization is due to its documented mechanism of action, which involves modulating the neural pathways in the brain that regulate emotional reactivity and tension.


Q: Can Адаптол cause temporary changes in body temperature?

A: Yes, a decrease in body temperature, known as hypothermia, is documented as a rare adverse reaction in official safety information. This source also notes that any changes in body temperature that may occur are typically documented to normalize after treatment completion.


Q: Can Адаптол be used for quitting smoking?

A: Official administration guidelines mention the use of the medicine in specific supportive protocols, including for nicotine cessation support.

How should Адаптол be stored and disposed of?

How to Store and Dispose of Adaptol (Mebicar)

Official regulatory information provides specific, mandatory conditions for storing and disposing of Adaptol tablets to maintain product stability and protect the environment.


Storage Requirements

Adaptol must be stored in its original package to ensure protection from light and moisture. The required storage temperature must not exceed 25 C, with some regulations specifying a range of 15 C to 25 C in a dry environment. The medicine must not be used after the expiry date printed on the package.

Safety and Disposal

For child safety, this medicine must always be kept out of the sight and reach of children. Unused or expired Adaptol must not be thrown away via wastewater or general household waste. Patients are instructed to ask their pharmacist for guidance on proper disposal, as these measures are required to help protect the environment.

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

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