Is etifoxine safe for treating anxiety in individuals over 12 years old?

Etifoxine Safety for Anxiety Treatment in Individuals Over 12 Years Old

Etifoxine should not be used for more than 12 weeks in individuals over 12 years of age for anxiety treatment, as its safety beyond this duration has not been established. 1

Safety Profile of Etifoxine

• Etifoxine (Stresam®) is a non-benzodiazepine anxiolytic developed in the 1960s for anxiety disorders 1
• The recommended dosage is 150 mg per day with a maximum treatment duration of 12 weeks 1
• Unlike benzodiazepines, etifoxine shows fewer adverse effects such as anterograde amnesia, sedation, impaired psychomotor performance, and withdrawal syndromes 2
• The most common adverse effect is drowsiness at the initial stage of treatment 1
• Etifoxine does not typically cause withdrawal syndromes when discontinued 1, 2
• Significantly less rebound anxiety has been observed after abrupt cessation of etifoxine compared to benzodiazepines like lorazepam or alprazolam 2

Contraindications and Precautions

• Etifoxine is contraindicated in situations such as shock, severely impaired liver or kidney function, and severe respiratory failure 1
• Skin and subcutaneous disorders are the most frequently reported adverse events, but these generally resolve after drug cessation 2
• Unlike benzodiazepines, etifoxine appears to have a very low dependence potential 2
• Etifoxine has no significant effect on psychomotor performance, vigilance, or free recall, unlike lorazepam 2

Comparison with Other Anxiety Treatments

• For adolescents (12-18 years), SSRIs are the first-line pharmacological treatment for anxiety disorders according to clinical practice guidelines 3
• The American Academy of Child and Adolescent Psychiatry recommends cognitive-behavioral therapy (CBT) as the initial treatment for anxiety disorders in adolescents 4
• For moderate to severe anxiety with significant functional impairment, combination treatment (CBT plus medication) may be more effective than either treatment alone 3, 4
• SSRIs such as fluoxetine, fluvoxamine, paroxetine, and sertraline have substantial empirical support for effectiveness and safety in treating anxiety in adolescents 3
• SNRIs could also be offered to patients 6 to 18 years old with anxiety disorders, with duloxetine being the only SNRI with FDA indication for generalized anxiety disorder in children 7 years and older 3, 4

Monitoring and Safety Considerations

• Close monitoring for adverse effects is essential, particularly during the first 4 weeks of treatment with any anxiety medication 4
• Key adverse effects to monitor include suicidal ideation and behavior, behavioral activation/agitation, gastrointestinal symptoms, weight changes, and sleep disturbances 4
• The pooled absolute rates for suicidal ideation across all antidepressant classes for youth treated for anxiety have been reported to be 1% compared to 0.2% for those treated with placebo 3
• Using standardized symptom rating scales to systematically track treatment response is recommended 4

Clinical Considerations for Etifoxine Use

• Etifoxine has been shown to be non-inferior to alprazolam in the treatment of adjustment disorder with anxiety in adults 5
• After medication discontinuation, anxiety scores continued to improve in etifoxine-treated patients but increased in alprazolam-treated patients 5
• Etifoxine works through dual mechanisms: modulation of GABAergic neurotransmission and stimulation of neurosteroid production 1, 2
• Recent data suggest that etifoxine possesses neuroprotective, neuroplastic, and anti-inflammatory properties 2

Important Limitations and Gaps

• Most clinical guidelines for anxiety treatment in adolescents focus on SSRIs and SNRIs rather than etifoxine 3
• The Japanese Society of Anxiety and Related Disorders guideline specifically excludes children and young patients under 18 years of age from its recommendations on social anxiety disorder treatment 3
• There is limited research on etifoxine specifically in adolescent populations, with most studies focusing on adult populations 2, 5
• The 12-week limitation for etifoxine treatment suggests caution for long-term management of chronic anxiety disorders 1