Index of drugs

Short-term treatment of insomnia in adults in case of insomnia weakening or causing extreme exhaustion. Benzodiazepines or benzodiazepine-like drugs are indicated only if sleep disturbances are severe, prevent normal functioning and cause extreme exhaustion.

1 tabl powl. contains 10 mg of zolpidem tartrate. The drug contains lactose.

A sleeping drug from the imidazopyridine group. In experimental studies it has been shown that it has a calming effect in doses lower than those that cause anticonvulsant, myorelaxis or anxiolytic effects. This action is associated with specific agonist effects on central receptors belonging to the "GABA-omega" large-molecule receptor complex (BZ1 and BZ2), which modulates channel opening for chloride ions. Zolpidem mainly works on the subtypes of the omega receptor (BZ1). After oral administration, zolpidem is rapidly absorbed from the gastrointestinal tract, reaching C_max within 0.5-3 h. Bioavailability is 70%. It is 92% bound to plasma proteins. First-pass metabolism in the liver is about 35%. Zolpidem is excreted as metabolites, mainly in the urine (56%) and faeces (37%). T_0,5 is 2.4 h, while the duration of action is about 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 h). A moderate decrease in clearance is observed in patients with renal impairment.

Hypersensitivity to zolpidem or other ingredients of the preparation. Severe hepatic failure. Sleep apnea syndrome. Severe respiratory failure.Myastenia gravis. Children and youth under 18 years.

After repeated use over a period of several weeks, the hypotensive effect of short-acting benzodiazepines and benzodiazepine-like hypnotics may develop. The use of benzodiazepines or benzodiazepine-like drugs can lead to the development of physical and mental dependence. The risk of addiction increases with increasing dose and duration of treatment; it is also greater in patients with mental disorders and / or alcohol or drug addiction. In cases where physical dependence has developed, a sudden discontinuation of treatment will be accompanied by withdrawal symptoms. Transient syndrome, consisting of intensification of symptoms that were the reason for starting treatment with benzodiazepines or benzodiazepine-like drugs, may occur after discontinuation of treatment. Symptoms may be accompanied by other reactions, including mood changes, anxiety and anxiety. When using benzodiazepines and benzodiazepine-like drugs with a short duration of action, the withdrawal syndrome may occur in between doses, especially if high doses are taken. Since the occurrence of withdrawal symptoms / "rebound" symptoms is more likely after abrupt cessation of treatment, a gradual dose reduction is recommended. Caution should be exercised in patients with chronic respiratory failure (benzodiazepines may inhibit the activity of the respiratory center), in elderly or weakened patients (risk of falls and consequent fracture of the femoral neck) and in patients with renal insufficiency. Benzodiazepines are not indicated for the treatment of patients with severe hepatic impairment (risk of accelerating the development of hepatic encephalopathy). The use of benzodiazepines and benzodiazepine-like preparations as basic medicines in patients with mental illness is not recommended. Use with caution in patients with depressive symptoms. There may be suicidal tendencies. Due to the possibility of intentional overdosing by the patient, the lowest possible amounts should be prescribed. Depression and anxiety associated with depression are not recommended as monotherapy (risk of increased suicidal tendencies).The use of the preparation may lead to tolerance and mental addiction - special care should be taken in patients with a history of alcohol or drug addiction. Benzodiazepines may cause secondary amnesia. Symptoms of amnesia usually occur a few hours after taking the drug. In order to reduce the risk, the patient should be provided with the possibility of uninterrupted 8-hour sleep. The risk of day-to-day psychomotor disorder, including impaired driving ability, is increased if: zolpidem was taken less than 8 hours before activities requiring consciousness, higher than recommended dose, other CNS depressants or other medicines that increase the concentration of zolpidem in the blood, alcohol or substances not allowed. When using benzodiazepines or benzodiazepine-like medicines, symptoms such as restlessness, agitation, irritability, aggressiveness, delusions, fits of rage, nightmares, hallucinations, psychoses, somnambulism, inadequate behavior, and increased insomnia may occur. If they occur, stop taking the medicine. The occurrence of these reactions is more likely in elderly patients. The tablets contain lactose - they should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The drug should not be used during pregnancy (especially in the first trimester). The drug used in the final period of pregnancy or during delivery may cause hyponatraemia, low blood pressure and moderate respiratory failure in the newborn. In neonates whose mothers have taken long-term benzodiazepines during the last period of pregnancy, withdrawal symptoms during post-natal period may develop as a result of physical dependence. Zolpidem is excreted in small amounts in breast milk - do not use the drug during breastfeeding.

Common: drowsiness the day after taking the drug, emotional indigestion, decreased alertness, confusion, fatigue, headache and dizziness, double vision, dizziness, ataxia, weakness in muscle strength. Uncommon: diarrhea, nausea, vomiting, skin reactions, paradoxical reactions (anxiety, agitation, irritability, aggressiveness, delusions, fits of anger, nightmares, hallucinations, psychoses, somnambulism, inadequate behavior or other behavioral side effects), progressive amnesia that it may be associated with inadequate behavior. Not known: increased liver enzymes, excessive sweating, angioneurotic edema, disturbances of walking, falls, development of tolerance to the drug, fall (especially in elderly patients and when the drug was not taken as directed), decreased libido. Benzodiazepines or benzodiazepine-like medicines can cause post-mortem amelioration or the appearance of pre-existing depression. Using the drug (even in therapeutic doses) can lead to the development of physical and mental dependence. Discontinuation of treatment may lead to withdrawal symptoms (headache and muscle pain, anxiety, tension, anxiety, confusion, irritability, in severe cases: derealization, depersonalization, hyperaesthesia, numbness and tingling of the extremities, hypersensitivity to light, noise and touch, hallucinations or convulsive attacks) or transient insomnia "with rebound".

Orally. Adults: 10 mg daily (maximum dose), immediately before bedtime. Do not take the Next dose on the same night. Treatment with the preparation should be as short as possible. Typically, the duration of treatment is from several days to 2 weeks, 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-evaluation of the patient's condition.Special groups of patients. In the elderly, in patients who are attenuated and in patients with hepatic insufficiency, the recommended dose is 5 mg daily; this dose can be increased up to 10 mg a day for good tolerability. The product is not recommended for use in children and adolescents <18 years.Way of giving. The tablets should be taken immediately before bedtime with a liquid.