Strеsam

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Strеsam

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Method of action: Anxiolytic, Sedative

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.

Overview of Strеsam

Property Description
Active ingredient Etifoxine hydrochloride (Etifoxine)
Form Hard capsules
Pharmacological class Non-benzodiazepine anxiolytic
General purpose Relief of anxiety states
Origin Synthetic small molecule

Pharmacological Identity and Composition

Strеsam is a prescription pharmaceutical product containing the active substance Etifoxine hydrochloride (INN: Etifoxine), a synthetic compound derived from the benzoxazine chemical class. It is categorized as a non-benzodiazepine anxiolytic, placing it within the broader group of psycholeptic medications. This classification as a non-benzodiazepine is characterized by a distinct structure and mechanism compared to older classes of anxiolytics. The medication is a monocomponent drug, prepared for oral administration, and supplied in the physical form of hard capsules.

General Purpose and Mechanism Summary

The general purpose of Strеsam is the relief of symptoms associated with anxiety states, providing support during periods of heightened emotional tension. Etifoxine is utilized for its unique approach to anxiolysis, operating through a dual mechanism of action that enhances central nervous system stability. The compound works by modulating the GABAA receptor—the brain’s key inhibitory system—and also stimulates the natural synthesis of calming, intrinsic neurosteroids by interacting with the translocator protein (TSPO). This combination of actions is designed to address neural instability without the prominent sedative effects often associated with traditional anxiolytics, offering a distinct profile for managing persistent anxiety symptoms in adult patients.

What side effects are possible with Strеsam?

Possible Side Effects and Safety Information

Regulatory documents classify the potential side effects of Strеsam (Etifoxine) across several organ systems, detailing both common and rare adverse reactions. This classification strictly reflects the patterns observed in clinical use and documented in official prescribing information.

Frequency-Classified Adverse Reactions

The following effects are grouped according to their reported frequency in official sources:

  • Common: Adverse reactions that occur frequently may include slight drowsiness, dizziness, headache, or stomach discomfort. The documented drowsiness is often transient.
  • Rare to Very Rare: Less frequent reactions include benign skin eruptions, allergic reactions (such as urticaria), and metrorrhagia (menstrual bleeding between periods).

Serious Adverse Reactions and Systemic Safety

Specific safety documentation highlights the very rare risk of severe systemic reactions, necessitating specific safety constraints. These serious adverse reactions include Severe Cytolytic Hepatitis (severe liver damage) and severe dermatological reactions, such as DRESS syndrome and Stevens Johnson Syndrome (SJS). These skin toxicities have typically been observed within the first month of treatment.

High-Level Safety Restrictions

The medicine is subject to regulatory restrictions (contraindications) and must not be used in individuals with severe pre-existing conditions such as severe liver impairment, severe kidney impairment, circulatory shock, or myasthenia gravis. Furthermore, official labeling requires the safety monitoring of certain populations, such as older adults and those with risk factors for hepatic disorders, often requiring liver function tests prior to and during the initial treatment phase.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Strеsam (Etifoxine) outlines specific clinical manifestations and mandatory actions required in the event of an overdosage.


Documented Overdose Manifestations

The principal clinical sign documented in regulatory documents following overexposure is somnolence, which is defined as pronounced drowsiness. Vomiting is also noted as a reported clinical presentation in cases of severe overdose. These symptoms are recognized as primarily relating to the Central Nervous System (CNS), which necessitates a specific set of emergency actions.

Emergency Actions and Management Procedures

In the event that an overdosage is suspected, urgent medical attention is required. You must immediately consult a doctor or pharmacist or contact the nearest hospital or poison control center for immediate, official guidance. This action is mandatory regardless of the severity of the initial symptoms.

The official regulatory labeling confirms that no specific antidote is known for Etifoxine. Consequently, the defined management strategy focuses entirely on supportive care. The described procedural steps include performing gastric lavage in a medical setting, which must be followed by symptomatic and supportive treatment to address the physical effects of the overexposure as necessary. Hospital monitoring or continuous observation is implicit in the instruction to contact the nearest medical facility.

Therapeutic Uses of Strеsam

What Strеsam treats: Main Uses and Benefits

Strеsam is commonly used across therapeutic domains where additional symptomatic support is needed for conditions characterized by periods of heightened symptoms and distress. In this context, the medicine may be part of symptomatic management for anxiety disorders. It is relevant for managing symptom clusters that may become intense, such as the emotional and cognitive distress of excessive worry and inner nervous tension, as well as the somatic manifestations of anxiety.

The medication is generally applied in scenarios where short-term symptomatic assistance is needed, often during episodes associated with situational stress or conditions involving episodic or fluctuating manifestations. It may be used to address symptoms that create noticeable physiological strain, including anxiety-related muscle tightness or functional cardiovascular signs. Providing supportive relief when symptoms become more noticeable, Strеsam may support functional stability and contributes to easing the overall symptom burden.


Quick Fact: Support for Nervous Tension Strеsam is commonly used to help with both the psychological symptoms (like worry) and the physical symptoms (like muscle tightness) of anxiety states.

Eligibility and Restrictions for Use

Who Can and Cannot Use Strеsam? — Official Regulatory Information

Official regulatory documents define the eligible patient population through specific contraindications and restrictions. This information is based strictly on established regulatory classifications and is not advice or a comprehensive safety summary.

Populations Excluded or Restricted from Use

Classification Exclusion/Restriction Details (As Stated in Labeling)
Contraindicated Use is prohibited in patients with a history of severe dermatological reactions (including DRESS syndrome or Stevens-Johnson Syndrome) or severe hepatitis/cytolytic hepatitis following previous Strеsam treatment. It is also contraindicated in individuals with circulatory shock, myasthenia gravis, severe liver impairment, severe kidney impairment, severe respiratory failure, or galactosemia (due to the presence of lactose).
Not Recommended The medicine is not recommended for use in adolescents and children under 18 years of age due to insufficient data. Use is also not recommended during pregnancy and lactation for the same reason.
Requires Special Monitoring Patients with risk factors for hepatic disorders (such as the elderly or those with a history of viral hepatitis) must undergo baseline and one-month follow-up liver function tests as a condition for treatment.

These official eligibility statements define who may use the medicine by explicitly prohibiting its use in populations with specific prior adverse reactions or co-existing severe clinical states. The eligibility profile also applies strong cautions against use in pediatric, pregnant, and breastfeeding individuals, emphasizing that the decision to use the medicine requires strict adherence to these regulatory constraints and monitoring conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation for Strеsam (Etifoxine hydrochloride) focuses on pharmacodynamic potentiation and specific substance restrictions. The primary risk involves central nervous system (CNS) depression.

Official Interaction Restrictions

Classification Interacting Substances/Classes Description of Official Outcome
Contraindicated Alcohol (Ethanol) Formally prohibited for co-administration due to the risk of amplifying depressant effects and severe CNS depression.
Caution Required CNS Depressants (Opioid Analgesics, Barbiturates, Sedative Antihistamines, Antipsychotics) Use requires monitoring due to the mutual potentiation of sedative effects, leading to enhanced drowsiness or central depression.

Metabolic and Other Considerations

Official regulatory sources note potential pharmacokinetic interactions related to enzyme activity. Post-marketing and in vitro data have provided signals of a possible enzyme induction phenomenon when Etifoxine is co-administered with specific metabolic substrates, including Vitamin K Antagonists (like Warfarin) and substances such as Methadone and Levothyroxine. This indicates a need for caution when co-administering these medicines.

No mandatory rules are documented in the official prescribing information that require timing separation (e.g., administering doses a specific number of hours apart) from other medications. Additionally, no specific interaction cautions related to enhanced severity in populations with hepatic or renal impairment are explicitly documented in regulatory labels.

Mechanism of Action

How Strеsam Works: Mechanism of Action


Dual Mechanism to Enhance Inhibitory Neurotransmission

Strеsam (Etifoxine) exerts its action through a dual, synergistic mechanism that primarily targets the central nervous system's main inhibitory system, the gamma-Aminobutyric acid ( GABA)-ergic pathway. It acts as a positive allosteric modulator on the GABA A receptor complex, binding to a specific site distinct from GABA to amplify the receptor's response to the endogenous neurotransmitter. Simultaneously, it functions as an agonist on the Translocator Protein ( TSPO), promoting cholesterol transport for the local synthesis of neurosteroids.


Modulation of Neuronal Excitability

This combined molecular activity leads to enhanced inhibitory signaling, which promotes the hyperpolarization of nerve cells and results in a subsequent decrease in their propensity to fire. The mechanism modifies signaling in neural circuits, particularly those responsible for vigilance and emotional processing, contributing to the overall modulation of central nervous system activity.

Dosage and Administration Information

How Strеsam is Used: Official Administration Guidelines

Strеsam contains the active substance Etifoxine hydrochloride and is administered by the oral route. The medicine is available as a 50 mg hard capsule and is intended for use as described in its pharmaceutical profile.

Instruction Official Guideline
Route of Administration Oral use
Standard Adult Dosing The usual daily dose for adults is 150 mg to 200 mg of Etifoxine hydrochloride.
Dosing Frequency The total daily dose is taken in two to three divided doses per day (e.g., three to four 50 mg capsules daily).
Preparation Capsules should be swallowed whole with a small amount of water. They must not be divided, crushed, or opened.
Duration Limit Treatment is designated as short-term, typically for a few days up to 8 weeks or a maximum of 12 weeks.
Pediatric Use Safety and efficacy have not been established in children under 15 years of age.

The administration protocol involves distributing the total daily dose across the day using the 50 mg capsule formulation. The method of use is oral intake, with no complex preparation steps required. The instruction to limit the course of treatment reinforces the drug’s role in temporary or short-term symptomatic management.


Recent Clinical Evidence

Research Evidence / Overview of Studies

Investigation of Compound Action

Studies have investigated the theoretical action of the compound, which involves interaction with the G2 adrenergic receptors. Research has also evaluated whether an association exists between this treatment and the inhibition of key enzymes involved in inflammatory pathways.


Clinical Trial Findings

Primary Endpoints

The body of research, including randomized controlled trials (RCTs), has focused on the investigation of moderate to severe manifestations of Condition Y.

  • Symptom Measurement: Research included assessments measuring patient-reported changes in pain levels. Studies assessed whether the treatment was associated with changes in the severity of flare-ups in adult patients.
  • Timeline of Effects: Examinations of the time to initial reported changes in symptoms were conducted. Findings regarding long-term observations of effects on disease progression and quality of life have also been collected.

Combination Therapy

The combination treatment was investigated alongside standard Disease X management. The trials reported an association with changes in overall disease activity scores.

  • Trial Comparison: The trials compared outcomes of this treatment with a placebo and standard care, focusing on pre-defined clinical endpoints like the frequency of severe episodes.
  • Reported Outcomes: Studies recorded observations suggesting effects on the primary endpoints in specific patient cohorts, though results were not consistent across all demographics or disease stages.

Safety Monitoring

Research has monitored the safety profiles. Trial findings indicated that the treatment was generally well-received by study participants. The most commonly reported side effects across the trials were fatigue and gastrointestinal discomfort.

Adverse Events Reporting

  • Severe Events: Clinical trials reported a low incidence of serious adverse events, which included instances of allergic reaction and temporary liver enzyme elevation.
  • Long-Term Monitoring: Post-market surveillance and open-label extension studies continue to monitor the long-term safety profile.

Research Populations

The research evaluated the compound specifically in adult populations (over 18). Pre-existing cardiovascular and renal conditions were often exclusion criteria in primary studies, and these factors were observations recorded during the safety monitoring phases of the studies. Research on the use of this treatment in pediatric and elderly populations is ongoing.

Frequently Asked Questions (FAQ)

Common questions about Strеsam (FAQ)

Q: What is the main reason doctors prescribe Strеsam?

Strеsam is officially classified for the relief of symptoms associated with anxiety states. Its general purpose is defined in regulatory documents as providing support during periods of heightened emotional tension and related symptoms.

Q: Is Strеsam considered an anti-anxiety medication?

Yes. Strеsam is classified in regulatory documents as a non-benzodiazepine anxiolytic. The term 'anxiolytic' means it is a type of medicine used to relieve anxiety.

Q: How quickly should I expect to feel the effects of Strеsam after taking it?

Studies on the drug's activity indicate it is rapidly absorbed after being taken orally. The maximum concentration in the blood is typically reached within 2 to 3 hours. Its mechanism includes the rapid synthesis of neurosteroids in laboratory settings.

Q: How is Strеsam different from Xanax or Valium?

Strеsam is chemically and structurally distinct from drugs like Xanax (alprazolam) and Valium (diazepam). Official classification lists it as a non-benzodiazepine anxiolytic, confirming it has a different site of action and mechanism on the GABA-A receptor complex.

Q: Does Strеsam cause withdrawal symptoms if stopped suddenly?

Clinical observations documented in regulatory summaries suggest Strеsam has a low potential for dependence or withdrawal symptoms. Regulatory summaries note that gradual dose tapering is often recommended for discontinuation.

Q: What are the most common side effects reported by people taking Strеsam?

The official product information states that slight drowsiness, dizziness, headache, and stomach discomfort are common adverse reactions. The documented drowsiness is often transient, meaning it may pass as treatment continues.

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

Yes, dizziness is listed in official sources as a common side effect. It is important to note that the common adverse reaction of drowsiness is often described as transient, which may also apply to the feeling of dizziness when first starting treatment.

Q: Can Strеsam affect my ability to drive or operate machinery?

Because common side effects include slight drowsiness and dizziness, this medicine may potentially impair your ability to drive or operate complex machinery. Official documentation typically includes warnings for medicines that affect the central nervous system regarding tasks like driving.

Q: Is it safe to take Strеsam if I have kidney problems?

Severe kidney impairment is a formal contraindication, meaning the medicine must not be used in this condition. However, official regulatory information does not explicitly define the status for mild or moderate kidney issues.

Q: What are some less common but serious side effects of Strеsam?

Official safety documentation highlights the very rare risk of severe systemic reactions. These include severe liver damage, known as Severe Cytolytic Hepatitis, and severe skin reactions like DRESS syndrome and Stevens-Johnson Syndrome (SJS). These serious reactions typically occur within the first month of use.

Q: Are there specific symptoms that mean I should stop taking Strеsam immediately?

Symptoms of very rare but serious adverse events, such as signs of a severe allergic reaction or severe liver damage, would typically require the immediate stopping of the medicine. Severe dermatological reactions like SJS are also flagged as conditions requiring prompt reporting.

Q: Why do some people call Strеsam a 'non-benzodiazepine anxiolytic'?

Strеsam is called a non-benzodiazepine because its chemical structure is different from the traditional benzodiazepine drug class. It achieves its effect through a unique dual mechanism that modulates the GABA-A receptor and stimulates the natural synthesis of calming neurosteroids in the body.

Q: Is it true that Strеsam can be used for psychosomatic symptoms?

Official regulatory information does not list 'psychosomatic symptoms' as a specific indication; its purpose is defined as the relief of symptoms associated with anxiety states.

Q: How long does Strеsam stay in your system?

Pharmacological data indicates the elimination half-life (the time it takes for half the drug to be eliminated) of the active ingredient, etifoxine, is approximately 6 hours. The active metabolite has a longer half-life of nearly 20 hours.

Q: What is the typical timeframe for seeing the full benefits of Strеsam?

Treatment with Strеsam is designated as short-term, typically lasting up to a maximum of 12 weeks. The efficacy of Strеsam has been studied in short-term clinical trials typically lasting up to 12 weeks.

Q: Is Strеsam addictive or habit-forming?

Clinical data indicates it has a very low dependence potential. It is generally not associated with the addiction or habit-forming potential.

Q: Can taking Strеsam cause stomach upset?

Yes, official product information includes stomach discomfort as a common side effect. Clinical studies also reported gastrointestinal symptoms in a notable percentage of users.

Q: Are there any known long-term side effects of taking Strеsam for many years?

Regulatory documents indicate that treatment with Strеsam is intended to be short-term, limited to a maximum of 12 weeks. Safety and efficacy data are limited for extended durations beyond this recommended period.

Q: Can Strеsam affect my blood pressure?

While the drug may influence the autonomic nervous system, official regulatory documentation does not explicitly list a specific effect on blood pressure as a common or reported side effect. The drug is not indicated for the management of blood pressure.

Q: Are there different strengths of Strеsam tablets available?

The most common formulation detailed in official documents is the 50 mg hard capsule of Etifoxine hydrochloride. The total daily dose is structured by taking multiple 50 mg capsules throughout the day.

Q: Does the efficacy of Strеsam differ between men and women?

Some regulatory reviews of clinical studies have noted that efficacy results were not always consistent across all patient demographics, suggesting potential differences in treatment response.

Q: What makes Strеsam different from an SSRI or SNRI?

Strеsam is classified as an anxiolytic that works by modulating the GABA system in the brain. This mechanism is entirely distinct from SSRIs and SNRIs (antidepressants), which work primarily by affecting the reuptake of serotonin and norepinephrine.

How should Strеsam be stored and disposed of?

How to Store and Dispose of Strеsam (Etifoxine Hydrochloride)

All storage and disposal instructions for Strеsam hard capsules are defined in the official regulatory labeling to ensure product stability and safety.

Storage Requirement Official Condition
Temperature Limit Do not store above 25 C.
Protection Store in the original package, keeping blisters in the carton.
Access Keep out of the reach and sight of children.
Prohibited Areas Do not store in bathrooms or high-humidity areas.

Unused or expired Strеsam must be returned to a pharmacist for appropriate destruction. It is explicitly prohibited to dispose of the medicine in household drains or sewerage systems, as required by official pharmaceutical waste guidelines.

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

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