A sleeping drug from the imidazopyridine group. It selectively binds to the subtype of the omega-1 receptor, which is the alpha-receptor of GABA-A. Modulation of channel activity for chloride ions through this receptor leads to the occurrence of specific sedative effects of zolpidem. The drug shortens the latent sleep phase, reduces the number of nocturnal awakenings, extends the duration of sleep and improves its quality. The second sleep phase and the deep sleep phase (III and IV) are prolonged, at the recommended doses the drug does not affect the duration of the REM phase. The oral bioavailability is 70%. The maximum concentration in the blood occurs after 0.5-3 h. Plasma proteins are bound in 92%. It is metabolized in the liver and excreted as inactive metabolites mainly in the urine (approximately 60%) and faeces (approximately 40%). It does not induce liver enzymes. T0,5 it is about 2.4 h (0.7-3.5 h). In elderly patients, the hepatic clearance is reduced, the maximum concentration of the drug in the blood is about 50% higher, T0,5 lengthens (up to approx. 3 h). In patients with renal insufficiency (dialysed or not), the renal clearance is moderately reduced. In patients with hepatic impairment, the bioavailability of the drug increases, T0,5 it lengthens (up to about 10 hours).
Contraindications:
Hypersensitivity to zolpidem or other ingredients of the preparation. Severe hepatic failure. Sleep apnea syndrome. Severe and / or severe respiratory failure. Muscle tiredness(myasthenia gravis).
Precautions:
Use with caution in patients with impaired respiration, in elderly or weak patients, and in patients with hepatic impairment. Do not use the preparation in children under 18 years of age, due to the lack of data on the efficacy and safety of use in this age group. The use of hypnotics in the initial treatment of mental illness is not recommended. Caution should be exercised in patients with symptoms of depression (suicidal risk) and prescribed the lowest dose to prevent intentional overdose. The use of zolpidem may mask the symptoms of pre-existing depression. If used for more than a few weeks, the hypnotic effect may be reduced (tolerance). The use of the preparation may lead to the development of mental or physical dependence, especially in patients with mental disorders and / or alcohol or drug addiction in the past. The product contains lactose - should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Avoid using the drug during pregnancy. The use is not recommended during breastfeeding.
Side effects:
Common: drowsiness, pain and dizziness, worsening of insomnia, amnesia (may be associated with abnormal behavior), hallucinations, agitation, nightmares, fatigue, diarrhea, nausea, vomiting, abdominal pain, upper or lower respiratory tract infection. Uncommon: confusion, irritability, double vision. Frequency unknown: disturbances of consciousness, anxiety, aggression, delusions, anger, behavioral disorders, somnambulism, addiction (discontinuation symptoms or rebound phenomena may occur after discontinuation of treatment), libido disorder, depression, gait disturbances, tolerance to drug, falls ( mainly in elderly patients), respiratory depression, muscle weakness, rash, pruritus, urticaria, hyperhidrosis, angioneurotic edema, increased liver enzymes. The use of sedatives and hypnotics (especially in elderly patients) may be accompanied by psychic and paradoxical reactions (anxiety, insomnia agitation, irritability, aggressiveness, delusions, fits of rage, nightmares, hallucinations, inadequate behavior and other behavioral disorders) - in such cases treatment should be discontinued. After discontinuation of treatment, insomnia may recur with symptoms such as mood swings, anxiety and anxiety.In cases where physical dependence has developed, the symptoms of withdrawal syndrome occur at the moment of abrupt discontinuation of treatment: headache, muscle aches, severe anxiety, psychological tension, anxiety, confusion, irritability; in severe cases: derealization, depersonalization, hypersensitivity to acoustic stimuli, light, touch, numbness and tingling of limbs, hallucinations, fits.
Dosage:
Orally. Adults: the recommended dose is 10 mg daily. Elderly or weak patients are advised to give a dose of 5 mg daily, the daily dose should not exceed 10 mg. In patients with liver failure, the dose should be reduced to 5 mg. In adults (under 65 years of age) there is a possibility of increasing the dose to 10 mg in the case of good patient status and good tolerability. The preparation should be taken immediately before going to bed or after laying down. To reduce the risk of follow-up obstruction, the patient should be given an uninterrupted 7-8-hour sleep after taking the medicine. Long-term use is not recommended. The recommended duration of use should not exceed 4 weeks. If necessary, the treatment period may be extended, but only after re-evaluation of the patient's clinical status.
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