Ambien is used for a short time to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.
Other names: Zolpidem
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Zolpidem is a hypnotic from the group of lmidazopyridines, close in pharmacological activity to benzodiazepines, which has effects qualitatively similar to those of other drugs in this group: muscle relaxant, anxiolytic, sedative, hypnotic, anticonvulsant, amnestic. The development of these effects is associated with a specific agonistic effect on the central omega receptors (benzodiazepine receptors of type I and II), related to macromolecular GABA receptor complexes, causing the opening of neuronal anion channels for chlorine.
Zolpidem selectively interacts with central type I benzodiazepine receptors (a subtype of omega-1 receptors). Therefore, the sedative effect of the drug is observed at lower doses than the doses required for the development of muscle relaxant, anticonvulsant and anxiolytic effects.
In humans: zolpidem shortens the period of falling asleep and reduces the number of awakenings, increases the total duration of sleep and improves the quality of sleep. These effects are associated with the characteristic EEG profile of the drug, which differs from that of benzodiazepines. Zolpidem prolongs stage II sleep and deep sleep (stages III and IV). At recommended doses, zolpidem does not affect the overall duration of REM sleep.
Absorption. After oral administration, the bioavailability of zolpidem is 70%, the maximum plasma concentration of the drug is reached 0.5-3 hours after administration.
Distribution. In the therapeutic dose range, the pharmacokinetics of zolpidem is linear. Communication with plasma proteins is about 92%. The volume of distribution in adults is 0.54±0.02 l/kg.
Metabolism and excretion. Zolpidem is excreted in the form of inactive metabolites (metabolism occurs in the liver), mainly by the kidneys (about 60%) and through the intestines (about 40%). Zolpidem does not induce liver enzymes.
The half-life (T1 / 2) is about 2.4 hours (0.7-3.5 hours).
In elderly patients, the hepatic clearance of the drug is reduced. The maximum concentration (Cmax) increases by approximately 50% with a slight increase in the half-life (up to 3 hours on average). The volume of distribution is reduced to 0.34±0.05 l/kg.
In patients with renal insufficiency (regardless of receiving or not receiving hemodialysis procedures), a moderate decrease in drug clearance is observed. Other pharmacokinetic parameters do not change. Zolpidem is not excreted by hemodialysis and other types of dialysis. In patients with liver failure, bioavailability increases, clearance decreases and T1 / 2 of zolpidem increases (up to 10 hours).
Treatment of transient and situational insomnia in adults with clinically significant (severe) sleep disturbance, including difficulty falling asleep.
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Due to insufficient data on the use of the drug in pregnant women, as a preventive measure, it is preferable to avoid the use of the drug Zolpidem during pregnancy, although animal studies have not revealed a teratogenic effect of zolpidem.
When using the drug in women of childbearing age, they should be warned about the need to consult a doctor about stopping the drug in case of planning a pregnancy or if pregnancy is suspected.
If it is necessary to use the drug during pregnancy, the ratio of the expected benefit to the mother and the possible adverse effects on the fetus or newborn should be taken into account.
When taking high doses of zolpidem in the second and third trimester of pregnancy, it is possible to reduce the mobility of the fetus and change its heart rate.
If zolpidem is taken at the end of pregnancy or during childbirth, it may enter the fetus and, based on the pharmacodynamic effects of zolpidem, hypothermia, decreased muscle tone, and moderate respiratory depression can be expected in the newborn. Cases of severe respiratory depression have been reported in the newborn when the mother received zolpidem in late pregnancy in combination with other drugs that depress the central nervous system (CNS).
In addition, children born to women who have taken long-term sedative/hypnotic drugs at the end of pregnancy may become physically dependent, and there is a risk of developing a "withdrawal" syndrome in the postnatal period. The time of onset of such phenomena depends on the rate of excretion from the body of the newborn sedative / hypnotic drug that entered it before birth from the mother through the placenta.
Breastfeeding period. Small amounts of zolpidem pass into breast milk, so zolpidem is not recommended for use during breastfeeding.
The drug is intended for oral administration.
The recommended dose for adults is 10 mg per day. The minimum effective dose should be taken and not exceed a dose of 10 mg.
The drug Zolpidem is taken immediately before going to bed or already in bed, since its effect begins very quickly. Zolpidem should be taken once and not repeated overnight.
Children: The safety and efficacy of zolpidem in children and adolescents under 18 years of age have not been established, therefore zolpidem should not be used in children and adolescents under 18 years of age.
Elderly patients: Due to the fact that elderly or debilitated patients may be particularly sensitive to the effects of zolpidem, it is recommended that such patients begin treatment with a dose of 5 mg. For dosing accuracy, zolpidem 5 mg tablets or zolpidem 10 mg tablets (scored) from another manufacturer should be used. The daily dose should not exceed 5 mg.
Patients with impaired liver function: In severe liver failure, the use of the drug is contraindicated. Since in patients with mild to moderate hepatic impairment, clearance decreases and the metabolism of zolpidem slows down, treatment should begin with a dose of 5 mg (for dosing accuracy, zolpidem 5 mg tablets or zolpidem 10 mg tablets (scored) from another manufacturer should be used), especially caution should be exercised in these elderly patients. The daily dose should not exceed 5 mg.
Long-term use of zolpidem, like other sleeping pills, is not recommended. The duration of treatment should be as short as possible: from a few days to four weeks, including a period of dose reduction. In some cases, it may be necessary to extend the treatment beyond the maximum periods, but only after a re-evaluation of the patient's condition.
The following duration of treatment is recommended: 2-5 days for transient insomnia (eg, travel time); 2-3 weeks with situational insomnia (for example, due to a traumatic situation).
Very short periods of treatment do not require gradual discontinuation of the drug. In the case of long-term use of the drug to reduce the possibility of developing rebound insomnia, the abolition of zolpidem should be carried out gradually (first, reducing daily doses and only then canceling the drug).
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The undesirable effects indicated below are presented in accordance with the following gradations of the frequency of their occurrence: very often ≥ 10%; often ≥ 1% - <10%; infrequently ≥0.1% - < 1%; rarely ≥ 0.01% - < 0.1%; very rarely <0.01% (including isolated cases); the frequency is unknown (based on the available data, the establishment of the frequency of occurrence is not possible).
Adverse effects, especially from the central nervous system, depend on the dose and individual patient response. They are more often observed in elderly patients, and their severity should theoretically be less when taking the drug immediately before going to bed or already in bed (see section "Method of application and doses").
Infectious and parasitic diseases: Common: upper respiratory tract infections, lower respiratory tract infections. Immune system disorders: Frequency unknown: angioedema. Mental disorders: Often: hallucinations, agitation, nightmares. Uncommon: confusion, irritability.
Frequency unknown: anxiety, aggressiveness, delirium, anger, psychosis, behavioral abnormalities, somnambulism (sleep walking, etc.) (see section "Special Instructions" subsection "Somnambulism and related complex behavior"), dependence, which can develop even with the use of therapeutic doses of the drug (after discontinuation of treatment, "withdrawal" syndrome or "rebound" effects may develop), libido disorders (sexual desire), depression
Nervous system disorders: Often: drowsiness, headache, dizziness, increased insomnia; cognitive impairment, such as anterograde amnesia (the effects of amnesia may be associated with behavioral disturbances), which can also be observed with therapeutic doses of the drug, although the risk of its development increases in proportion to the dose. Frequency unknown: decreased level of consciousness, attention disorder, speech disorders.
Violations of the organ of vision: Uncommon: diplopia.
Respiratory, thoracic and mediastinal disorders: Frequency unknown: respiratory depression (see section "With caution" and "Special instructions").
Gastrointestinal disorders: Often: diarrhea, nausea, vomiting, abdominal pain.
Liver and biliary tract disorders: The frequency is unknown: increased activity of "liver" enzymes in the blood, hepatocellular, cholestatic or mixed liver damage (see sections "Contraindications", "With caution", "Special instructions").
Skin and subcutaneous tissue disorders: Frequency unknown: rash, itching, urticaria, hyperhidrosis (excessive sweating).
Musculoskeletal and connective tissue disorders:Often: back pain. Frequency unknown: muscle weakness.
General disorders: Often: feeling tired. Frequency unknown: gait disturbance, addiction to the drug, falls (mainly in elderly patients and in case of non-compliance with prescribed recommendations for admission).
Drivers of vehicles and persons working with mechanisms or engaged in other potentially hazardous activities should be warned about the possible risk of developing adverse reactions, including drowsiness, slow reactions, dizziness, drowsiness, blurred / double vision, decreased concentration and speed of psychomotor reactions, impaired the ability to drive vehicles in the morning after taking zolpidem.
In order to minimize the risk of developing such reactions, it is recommended to provide the patient with an uninterrupted night's sleep for 7-8 hours.
The above reactions can be significantly increased when zolpidem is used in combination with other drugs that depress the central nervous system, and with alcohol (ethanol) (see section "Interaction with other drugs").
Patients should be warned not to take alcohol (ethanol) and drugs that depress the central nervous system while taking zolpidem.
Other drug to treat insomnia: Zopiclone
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