What is Stresam?
Stresam is the brand name for the active substance etifoxine hydrochloride, a non-benzodiazepine anxiolytic and anticonvulsant. It was developed in the 1960s and has been authorized for use in several European countries, including France, for decades. As a non-benzodiazepine, it offers a different pharmacological profile from more commonly known anxiety medications, with a lower risk of dependence and side effects like sedation and cognitive impairment.
Primary uses for anxiety
The primary indication for the drug Stresam is the treatment of anxiety disorders, especially those with significant psychosomatic manifestations. Psychosomatic symptoms are physical reactions to mental or emotional stress. This can include a wide range of physical symptoms that, while rooted in anxiety, can feel very real and distressing to the patient.
Common psychosomatic manifestations of anxiety that Stresam is used to treat include:
- Cardiovascular issues like palpitations and rapid heartbeat.
- Gastrointestinal problems such as irritable bowel syndrome and gastric ulcers.
- Physical tension and muscle aches.
- Sleep disturbances and insomnia.
- General feelings of agitation, fear, and nervous tension.
In addition to these symptoms, Stresam is also indicated for the short-term management of adjustment disorder accompanied by anxiety. The European Medicines Agency (EMA) concluded its review in 2022, affirming that the drug could continue to be used for anxiety disorders in some patients, with updated restrictions to minimize serious risks.
Mechanism of action
Etifoxine's anxiolytic effects are achieved through a dual mechanism of action, making it different from benzodiazepines.
- Direct action on GABA-A receptors: Etifoxine directly potentiates the function of GABA-A receptors, which are the main inhibitory neurotransmitter receptors in the brain. Unlike benzodiazepines that bind to one specific site, etifoxine binds to a different site, likely the β2 or β3 subunit, leading to a calming effect.
- Indirect modulation via neurosteroid production: Etifoxine also binds to the mitochondrial translocator protein (TSPO). This binding stimulates the synthesis of endogenous neurosteroids, such as allopregnanolone, which are potent positive allosteric modulators of GABA-A receptors. This dual action enhances the inhibitory effects of GABA, contributing to its anxiolytic properties.
Benefits beyond anxiety
Beyond its primary use for anxiety, etifoxine's effects on the nervous system and neurosteroid production have been studied for other potential therapeutic applications, with promising experimental results.
- Peripheral nerve regeneration: Studies have shown that etifoxine can promote the regeneration of injured peripheral nerves, accelerating axonal regrowth and functional recovery in animal models.
- Neuropathic pain relief: Research indicates that etifoxine can alleviate neuropathic pain and associated symptoms like anxiety and depression in animal studies. This effect is thought to involve its action on neurosteroids and modulation of inflammatory responses.
Safety and side effects
While considered safer than benzodiazepines concerning dependence and cognitive impairment, Stresam is not without side effects. Common adverse effects include temporary drowsiness, especially during the first few days of treatment, and headaches.
Rare but serious side effects include severe skin reactions (like Stevens-Johnson syndrome) and serious liver problems (such as cytolytic hepatitis). Patients with a history of such reactions to etifoxine are strictly contraindicated from using the drug.
Due to the risks of potentiating central nervous system depression, patients are cautioned against consuming alcohol or other CNS depressants while taking Stresam. Patients with pre-existing liver conditions may require monitoring with liver function tests.
Comparison with benzodiazepines
| Feature | Stresam (Etifoxine) | Benzodiazepines (e.g., Lorazepam) |
|---|---|---|
| Mechanism of Action | Dual mechanism: Direct GABAA modulation (different site) and indirect neurosteroid stimulation via TSPO. | Primary GABAA modulation at the classic benzodiazepine binding site. |
| Dependence Risk | Very low potential for dependency; no withdrawal symptoms reported upon discontinuation. | Significant risk of dependence, with potential for severe withdrawal syndromes. |
| Cognitive Effects | Minimal or no effect on alertness, memory, and cognitive performance. | Can cause dose-related anterograde amnesia and impaired cognitive function. |
| Sedation | Slight, transient drowsiness, especially at the start of treatment, typically less pronounced. | More significant sedative effects are common. |
| Side Effects | Rare but serious risks of skin and liver toxicity, common transient drowsiness. | Well-known for sedation, psychomotor impairment, and memory issues. |
| Duration of Use | Short-term; usually a few weeks, maximum 12 weeks for anxiety. | Often prescribed for short-term use due to dependence risk, though sometimes used chronically. |
Conclusion
In conclusion, the drug Stresam, with its active ingredient etifoxine, is an established non-benzodiazepine anxiolytic used in several countries for anxiety disorders, particularly those with psychosomatic symptoms. Its dual mechanism of action provides anxiolytic effects with a lower risk of dependency and less impact on cognition and alertness compared to traditional benzodiazepines. However, it is not approved for use in the US and comes with important safety restrictions, including a small risk of serious skin and liver issues. Due to its specific indications and safety profile, Stresam must be used under strict medical supervision and is contraindicated in specific patient populations.
Disclaimer
Note: This article is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before starting any new medication.
Frequently asked questions
What is Stresam used for and what is its main ingredient?
Stresam is used to treat anxiety disorders, especially those with psychosomatic symptoms like palpitations and digestive issues, and its main ingredient is etifoxine hydrochloride.
Is Stresam a benzodiazepine?
No, Stresam is a non-benzodiazepine anxiolytic that belongs to the benzoxazine chemical class. It has a different mechanism of action and a lower risk of dependence compared to benzodiazepines.
Where is Stresam available?
Stresam is authorized in several countries, including France, Malta, and Bulgaria, but it is not currently available in the United States.
What are the main side effects of Stresam?
The most common side effect is transient drowsiness, which usually subsides with continued use. Rare but serious side effects include severe skin reactions and liver toxicity.
Can Stresam be used for long-term treatment?
No, Stresam is typically prescribed for short-term treatment, ranging from a few days to a few weeks, and should not exceed 12 weeks for anxiety treatment.
Can Stresam be taken with alcohol?
No, combining Stresam with alcohol is not advised because alcohol can increase the sedative effects of the medication.
How does Stresam work in the body?
Etifoxine has a dual mechanism: it directly potentiates GABA-A receptors at a non-benzodiazepine site and indirectly modulates them by stimulating neurosteroid production through the mitochondrial translocator protein (TSPO).
Are there any withdrawal symptoms associated with Stresam?
Unlike benzodiazepines, abrupt discontinuation of Stresam typically does not result in withdrawal symptoms.
Who should not take Stresam?
Stresam is contraindicated in patients with severe liver or kidney impairment, myasthenia gravis, shock, and those with a history of severe skin reactions or liver damage from previous etifoxine treatment.
Does Stresam affect memory or alertness?
No, studies have shown that Stresam has minimal or no deleterious effects on alertness, psychomotor performance, or memory, unlike many benzodiazepines.
Can Stresam be used during pregnancy or breastfeeding?
No, the use of Stresam is not recommended during pregnancy or breastfeeding due to insufficient clinical data on its safety for these populations.
