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indications:
Short-term treatment of insomnia. Benzodiazepines or benzodiazepine-like drugs are only indicated for the treatment of severe insomnia that prevents normal functioning or causes extreme exhaustion.
Composition:
1 tabl powl. contains 10 mg of zolpidem tartrate.
Action:
A sleeping drug from the imidazopyridine group. In experimental studies, zolpidem has been found to have sedative properties in lower doses than required to achieve anticonvulsant, muscle relaxant or anxiolytic effects. These properties are related to the fact that zolpidem is a selective agonist that binds to the central receptors belonging to the "GABA-omega" (BZ1 and BZ2) high molecular molecule complex that modulates the opening of the chloride channel. The mechanism of action of zolpidem consists in the selective binding of the benzodiazepine omega (BZ1) receptors. After oral administration, zolpidem is rapidly absorbed from the gastrointestinal tract, reaching a maximum concentration in the blood after 0.5-3 h after administration. Bioavailability after oral administration is 70%. It binds 92% of plasma proteins. About 35% of the administered dose of the drug is metabolised by the liver in the "first pass" process. The drug is excreted as metabolites, mainly in the urine (56%) and faeces (37%). T0,5 drug is 2.4 h, while the duration of action is up to 6 h. In the elderly and in patients with hepatic impairment, there is an increased bioavailability of the drug, reduced clearance and an increase in half-life (approximately 10 hours). A moderate reduction in clearance was observed in patients with renal impairment.
Contraindications:
Hypersensitivity to zolpidem or other ingredients of the preparation. Severe hepatic failure. Sleep apnea syndrome. Myasthenia gravis. Severe respiratory failure. Do not use in children and adolescents under 18 years.
Precautions:
Particularly cautiously used in patients with renal insufficiency. Caution should be exercised when administering zolpidem to patients with chronic respiratory failure. Benzodiazepines and benzodiazepine-like drugs are not recommended as first-line medicines for the treatment of patients with mental illness. The drug should be administered with extreme caution in patients with symptoms of depression (benzodiazepines and similar medicines should not be used in monotherapy of depression or anxiety associated with depression - the risk of increased suicidal tendencies). Particularly cautiously use in patients with a history of alcohol or drug addiction. Use with caution in elderly or frail patients. The drug contains lactose - patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take the drug.
Pregnancy and lactation:
There is insufficient data to assess the safety of zolpidem administration during pregnancy and lactation, therefore the drug should not be used in pregnant women (especially in the first trimester) and during breastfeeding.
Side effects:
Common (> 1/100): drowsiness the day after the drug, pain and dizziness, numbness, decreased alertness, confusion, gastrointestinal disturbances (diarrhea, nausea, vomiting), double vision, skin reactions, amnesia. Uncommon (> 1/1000, <1/100): fatigue, muscle weakness, ataxia. Rarely (<1/1000): decreased libido, paradoxical reactions. These symptoms occur mainly at the beginning of treatment and disappear after repeated administration of the drug. Benzodiazepines or benzodiazepine-like medicines can cause post-mortem amelioration or the appearance of pre-existing depression. The use of benzodiazepines or benzodiazepine-like drugs (especially in the elderly) may be accompanied by paradoxical reactions (restlessness, agitation, irritability, aggressiveness, delusions, anger, nightmares, hallucinations, psychoses, inadequate behaviors, worsening insomnia and other behavioral effects ) - in such cases, treatment should be discontinued.Long-term use of benzodiazepines or benzodiazepine-like drugs can lead to the development of physical and mental dependence. Abrupt discontinuation of treatment may cause symptoms of withdrawal syndrome or rebound syndrome (headache, muscle aches, anxiety, tension, restlessness, confusion, irritability, insomnia, in severe cases also feeling unreality, hypersensitivity to stimuli, numbness and tingling of the limbs, hallucinations and fits), for this reason it is recommended to gradually reduce the dose of the drug.
Dosage:
Orally. Adults: the recommended daily dose is 10 mg immediately before going to bed. In the elderly or attenuated and in patients with hepatic impairment, the recommended dose is 5 mg daily. The dose can be increased to 10 mg daily when the clinical response is unsatisfactory and the medicine is well tolerated. The total daily dose should not exceed 10 mg. Treatment with the preparation should last as short as possible. The duration of treatment is from several days to 2 weeks, and including the withdrawal period - maximum 4 weeks. In some cases, it may be necessary to extend the treatment period above the maximum recommended, only after re-assessment of the patient's condition.
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