Index of drugs

Short-term treatment of insomnia. The drug is used only in the treatment of insomnia disturbing the proper functioning or extremely burdensome for the patient.

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

A short-acting hypnotic of the imidazopyridine group. Zolpidem binds selectively to the subtype of the omega-1 receptor (also known as the benzodiazepine-1 subtype), which is an alpha-unit within the GABA-A-receptor complex. Modulation of channel activity for chloride ions through the receptor leads to a specific hypnotic effect. In humans, zolpidem shortens the time needed to fall asleep and reduces the number of awakenings, extends sleep and improves its quality. After oral administration, zolpidem is rapidly and well absorbed (70%), reaching C_max after 0.5-3 h. It binds plasma proteins in about 92%. It is metabolized in the liver, mainly with the participation of CYP3A4, into inactive metabolites that are excreted in urine (56%) and faeces (37%). Zolpidem can not be removed from the body by dialysis. T_0,5 is about 2.4 hours; drug action persists up to 6 h. Increased drug concentration has been observed in the elderly and in patients with hepatic impairment.

Hypersensitivity to zolpidem or to any of the excipients. Severe hepatic failure (risk of encephalopathy). Severe respiratory failure. Sleep apnea syndrome. Myasthenia gravis. Children and adolescents <18 years old.

The persistence of insomnia after 7-14 days of treatment may indicate a different basis of the disorder and provide an indication for the verification of the diagnosis. Zolpidem should be used with particular caution in patients with mental illness; after detoxifying treatments after an overdose, e.g. drugs; with liver failure; in old age or weakened; with breathing disorders (use the lowest recommended doses); with depression (the possibility of deliberate overdose, the smallest amount of the drug should be prescribed). Benzodiazepines and benzodiazepine-like drugs should not be used as the sole treatment for depression or anxiety associated with depression, as suicidal tendencies may occur in this group of patients. Because of the muscle relaxant effect, there is a risk of falls and bone fractures in the hip joint, especially in older patients when they get up at night. If you take zolpidem you may experience amnesia (especially if you do not have 7-8 h of sleep after taking the medicine), paradoxical reactions (in which case the drug should be discontinued), tolerance and addiction (especially during long-term use and in high doses and in patients who abuse alcohol) and drugs), discontinuation symptoms (in case of sudden cessation of use). The risk of occurrence of the next-day psychomotor disorders, including disturbances in the ability to drive vehicles, is increased if: zolpidem was taken in less than 8 hours before commencing activities requiring the presence of the mind; a greater than recommended dose was used; zolpidem is used concomitantly with other CNS depressants or other medicines that increase blood levels of zolpidem, alcohol or non-permitted substances. Zolpidem should be taken as a single dose immediately before bedtime and no further dose should be taken on the same night. Due to the lactose content, do not use the preparation in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The drug should not be used during pregnancy (especially in the first trimester). If indications are given for use with zolpidem later in pregnancy or during delivery, the effects of the drug on the newborn should be considered: hypothermia, hypotension, respiratory failure. In newborn babies born to mothers taking long-term benzodiazepines or drugs that act similar to benzodiazepines in the final stages of pregnancy, physical dependence may develop and withdrawal symptoms may occur.Zolpidem is excreted in small amounts in breast milk - use during breastfeeding is not recommended.

Palpitations (occasionally arrhythmia), changes in the blood picture (leukopenia, agranulocytosis), dizziness, feeling of bewilderment, headache, drowsiness, amnesia, apathy, emotional lability, sleep disorders, change of taste, ataxia, unsteady gait, nightmares, anxiety night vision, blurred vision, cough, asthma, diarrhea, nausea, vomiting, bloating, muscle spasms, arthritis, menstrual disorders, decreased libido, change in appetite, increased thirst, weight change, hypersensitivity reactions (rash, urticaria). Paradoxical reactions (psychomotor agitation, insomnia, irritability, delusions, nightmares, hallucinations, psychoses, change of behavior) may occur. There is a risk of falls and bone fractures in the hip joint. Long-term use of the drug may lead to physical and mental dependence. Abrupt discontinuation after long-term use may result in symptoms of withdrawal syndrome, whose symptoms are: insomnia, headache, myalgia, increased anxiety and tension, psychomotor agitation, confusion and irritability; less often: depersonalization, derealization, hyperaesthesia, numbness and tingling of the extremities, hypersensitivity to light, noise and touch, hallucinations or epileptic seizures.

Orally. Adults: a single dose of 10 mg immediately before bedtime. The maximum daily dose is 10 mg, do not take the Next dose of the drug the same night. The duration of treatment should be kept to a minimum; the treatment period should usually be several days up to 2 weeks; treatment should be discontinued within a maximum of 4 weeks, including the withdrawal period.Special groups of patients. In elderly (> 65 years old) or debilitated patients, treatment should be started at a dose of 5 mg (1/2 plate). In patients with hepatic impairment, treatment should be initiated at a dose of 5 mg (½ surface tablet); there is a possibility of increasing the dose if the patient is in good condition and when the medicine is well tolerated.