Europe — EMA
Heminevrin (Clomethiazole Edisilate)
Heminevrin (clomethiazole edisylate) is an EU‑approved oral sedative‑hypnotic for alcohol withdrawal, sedation and insomnia. Learn uses, effects, and safety.
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What is Clomethiazole Edisilate?
Heminevrin is a prescription medication whose active ingredient is clomethiazole edisylate. It is supplied in oral dosage form, though specific strength and formulation details are not publicly disclosed. Classified as a thiazole‑derivative sedative, Heminevrin acts as a positive allosteric modulator of the GABA‑A receptor, enhancing inhibitory neurotransmission in the central nervous system. The product is marketed within the European Union and is available by prescription only.
What is Clomethiazole Edisilate used for?
Heminevrin is indicated for several clinical situations where central nervous system depression is required.
- Management of alcohol withdrawal syndrome - Procedural sedation in hospital settings - Short‑term treatment of severe insomnia - Adjunctive therapy for acute agitation - Supportive care in acute stress reactions
What are the side effects of Clomethiazole Edisilate?
Heminevrin may produce a range of side effects, varying from mild to serious.
Common: - Drowsiness or somnolence - Dizziness or light‑headedness - Headache - Nausea or gastrointestinal discomfort - Dry mouth - Mild hypotension
Serious: - Respiratory depression, especially when combined with other depressants - Severe hypotension or cardiovascular instability - Hepatic dysfunction or elevated liver enzymes - Allergic reactions such as rash or angioedema - Seizures or paradoxical excitation - Profound sedation leading to loss of consciousness
What precautions apply to Clomethiazole Edisilate?
When prescribing Heminevrin, clinicians should observe several safety considerations.
- Use only under direct medical supervision and according to approved indications - Assess liver function before initiation and monitor periodically - Avoid abrupt discontinuation to reduce risk of withdrawal phenomena - Exercise caution in elderly patients due to increased sensitivity to sedation - Contraindicated in patients with known hypersensitivity to clomethiazole or related compounds - Monitor respiratory status in individuals with pre‑existing respiratory compromise - Evaluate for potential dependence with prolonged use
What does Clomethiazole Edisilate interact with?
Heminevrin can interact with other medications, altering its safety profile.
Avoid: - Concomitant use of other central nervous system depressants (e.g., benzodiazepines, opioids, barbiturates, alcohol) - Monoamine oxidase inhibitors (MAOIs) - Certain antihistamines with sedative properties
Use with caution: - Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs) - Antiepileptic drugs that affect GABA pathways - Antihypertensive agents that may enhance hypotensive effects - Strong CYP450 inhibitors that could increase clomethiazole levels - Herbal supplements such as kava or valerian that have sedative actions



