Stresam is a non-sedating tranquilizer drug that is used to treat anxiety. Although not being a benzodiazepine, its anxiolytic effect is comparable to that of lorazepam. Several studies also suggest that tofisopam has neurotrophic action, and potentially can be used in peripheral nerve injury
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Stresam is a non-benzodiazepine anxiolytic drug, prescribed in France since 1979 for psychosomatic manifestations of anxiety. The active ingredient of Stresam is Etifoxine.
Its anxiolytic properties have been shown in rodents: etifoxine reduces stress-induced physiological and endocrine modifications, like hyperthermia, activation of colonic activity. Binding and electrophysiological experiments have demonstrated that etifoxine enhances the inhibitory GABAergic system notably implied in the regulation of anxiety, as do benzodiazepines, barbiturates and neurosteroids, by different ways.
It has an affinity with chloride channel coupled to the GABAA receptor complex, and binds to these receptors via an allosteric site distinct from benzodiazepines. Indeed, it has been shown that etifoxine preferentially acts on GABAA receptors containing the b2 or b3 subunit. The second way might involve the stimulation of mitochondrial-type benzodiazepine receptors known to control neurosteroid synthesis like allopregnanolone, also positive modulator of GABAA receptors with anxiolytic-like properties.
As sedative properties of benzodiazepines are mediated by the GABAA receptor alpha1 subtype, etifoxine, with regard to its pharmacological profile, might be distinguished from benzodiazepines in general in terms of its clinical effects and safety. In humans, its efficacy in the treatment of anxiety disorders has previously been shown in a double-blind controlled study. Compared to lorazepam, a short-acting BZD (elimination half-life of 12 h), no impairment in vigilance, mnesic or psychomotor performance was revealed in healthy young subjects receiving single oral doses of stresam (50 and 100 mg).
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Dosage and Administration
Orally, with a little water.
The dose of the drug is determined by the doctor, individually, depending on the condition of the patient.
Usually it is prescribed 1 capsule 3 times a day, or 2 capsules 2 times a day. (150-200 mg / day)
The duration of treatment is from several days to 4-6 weeks, depending on the condition of the patient.
The following are the undesirable phenomena (AEs) that were noted when taking this drug, according to the classification by system organ class and frequency of occurrence (“rare”: ≥1 / 10 000 and <1/1000, “very rare”:
<1/10 000) in decreasing order of frequency.
Nervous system disorders
Rarely: slight drowsiness that appears in the first days of treatment and usually disappears on its own during treatment.
Violations of the skin and subcutaneous tissue
Rarely: skin reactions: maculopapular rash, erythema multiforme, pruritus, swelling of the face.
Very rarely: allergic reactions: urticaria, angioedema.
Frequency is not established: anaphylactic shock, drug-induced hypersensitivity syndrome with eosinophilia, Stevens-Johnson syndrome, leukocytoclastic vasculitis.
Disorders of the liver and biliary tract
Frequency is not installed: hepatitis, cytolytic hepatitis.
Disorders of the genitals and breast
Frequency is not installed: metrorrhagia in women taking oral contraceptives.
Disorders of the gastrointestinal tract
Frequency not established: lymphocytic colitis.
Hypersensitivity to the active ingredient or another component of the drug, shock, myasthenia gravis, severe disorders of the liver and / or kidneys. Due to the presence of lactose in the preparation, the drug should not be used in galactosemia, glucose and galactose malabsorption syndrome, as well as in the case of lactase deficiency.
Not recommended for use under the age of 18 years.
potentiates the action of drugs that depress the central nervous system, such as opioid analgesics, barbiturates, sleeping pills, antihistamines, antipsychotics, etc. Also enhances the effects of alcohol.
Pregnancy and Lactation
It is not recommended to use the drug during pregnancy. If you detect pregnancy while taking the drug, you should consult with your doctor about the continuation of treatment.
It is not recommended to use the drug when breastfeeding.
If you experience skin or allergic reactions, as well as complications of the liver, the drug should be stopped.
In case of skipping the drug intake, do not double the dose at the next dose.
In connection with the risk of drowsiness, it is necessary during the treatment to avoid driving vehicles and activities requiring increased attention, for example, controlling various mechanisms.
IT IS NOT RECOMMENDED TO TAKE THE DRUG TOGETHER WITH ALCOHOLIC BEVERAGES.
DO NOT EXCEED THE PRESIGNED DOCTOR.
Symptoms: lethargy, excessive drowsiness. Treatment: If necessary, have symptomatic treatment. The specific antidote is absent.
- Brand name: Stresam
- Active ingredient: Etifoxine
- Dosage form: Capsules
- Manufacturer: Biocodex
- Country of Origin: France
- Synthesis of 6-chloro 2(-ethylamino)-4-methyl-4-phenyl-[-4-14C]-4H-3,1-benzoxazine (Etifoxine)
- Erratum: Efficacy of etifoxine compared to lorazepam monotherapy in the treatment of patients with adjustment disorders with anxiety: a double-blind controlled study in general practice (p 139–149)
- The anxiolytic etifoxine protects against convulsant and anxiogenic aspects of the alcohol withdrawal syndrome in mice
- A double blind parallel group placebo controlled comparison of sedative and amnesic effects of etifoxine and lorazepam in healthy subjects
- Evaluation of the psychotropic effect of Etifoxine through pursuit rotor performance and GSR
- The effects of a single administration of etifoxine on several psychological tests
- PREVENTIVE AND CURATIVE EFFECTS OF ETIFOXINE IN A RAT MODEL OF BRAIN OEDEMA
- Neurosteroid allopregnanolone mediates anxiolytic effect of etifoxine in rats
- Reduction and prevention of vincristine-induced neuropathic pain symptoms by the non-benzodiazepine anxiolytic etifoxine are mediated by 3α-reduced neurosteroids
- Etifoxine (Stresam®) for chemotherapy-induced pain?
- The anxiolytic etifoxine activates the peripheral benzodiazepine receptor and increases the neurosteroid levels in rat brain
- Implication of 5-HT2 receptor subtypes in the mechanism of action of the GABAergic compound etifoxine in the four-plate test in Swiss mice
- Effects of stress and etifoxine on pentobarbital-induced loss of righting reflex in Balb/cByJ and C57BL/6J mice
- Lack of interaction between etifoxine and CRF1 and CRF2 receptors in rodents
- Effects of etifoxine on stress-induced hyperthermia, freezing behavior and colonic motor activation in rats
- L’étifoxine : un nouveau regard sur le récepteur GABA et l’anxiété
- The modulatory effects of the anxiolytic etifoxine on GABAA receptors are mediated by the β subunit
- Effects of etifoxine on ligand binding to GABAA receptors in rodents
- Functional modulation of gamma-aminobutyric acidA receptors by etifoxine and allopregnanolone in rodents