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Pharmachologic effect
Zolpidem is a hypnotic drug belonging to the group of imidazopyridines, and is a selective agonist of the omega1-benzodiazepine receptor subclass. It has a sedative effect, while when used in normal doses it does not have anxiolytic, central muscle relaxant and anticonvulsant effects. Excites benzodiazepine receptors (omega) in the alpha subunit of GABA receptor complexes localized in the region of the IV plate of the sensory-motor cortex, reticular parts of the substantia nigra, visual tubercles of the ventral thalamic complex, pons, globus pallidus, etc. Interaction with omega receptors leads to the opening of neuronal ionoform channels for chloride ions.
Shortens the time to fall asleep, reduces the number of nocturnal awakenings, increases the overall duration of sleep and improves its quality. Prolongs stage II sleep and deep sleep stages (III and IV). Does not cause drowsiness during the day.
Pharmacokinetics
Zolpidem is rapidly absorbed from the gastrointestinal tract. The time to reach Cmax in plasma after oral administration is 0.5-3 hours. Bioavailability - 70%, plasma protein binding - 92%. There is a linear relationship between the dose of the drug and its plasma concentrations. Metabolized in the liver with the formation of three inactive metabolites, which are excreted by the kidneys (56%) and through the intestines (37%). The average T1 / 2 is 2.4 hours. Vd is 0.5 ± 0.02 l / kg. Does not induce liver enzymes. In the elderly, plasma clearance may decrease without a significant increase in T1 / 2 (on average 3 hours), while Cmax increases by 50%. In patients with severe renal impairment, clearance increases slightly. In patients with impaired liver function, bioavailability increases, T1 / 2 increases up to 10 hours. It is excreted in small amounts with breast milk.
Indications
Sleep disorders: difficulty falling asleep, early and nocturnal awakenings.
Dosage
Inside (just before bedtime) in a single dose of 10 mg.
In elderly or debilitated patients with impaired liver function, treatment is started with a dose of 5 mg. If necessary (insufficient clinical effect) and good tolerability of the drug, the dose can be increased to 10 mg. The maximum daily dose is 10 mg. The course of treatment should not exceed 4 weeks. With transient insomnia, the recommended course of treatment is 2-5 days, with situational insomnia - 2-3 weeks.
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 the daily dose and then canceling the drug).
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Side effects
Zolpidem is generally well tolerated.
The frequency of adverse reactions: very often - more than 10%, often - more than 1% and less than 10%, infrequently - more than 0.1% and less than 1%), rarely - more than 0.01% and less than 0.1%, very rarely - less than 0.01% ( including individual cases), the frequency is unknown (based on the available data, the establishment of the frequency of occurrence is not possible).
From the nervous system: often - drowsiness, feeling of intoxication, headache, dizziness, increased insomnia, anterograde amnesia (the effects of amnesia may be associated with behavioral reactions), the risk of which increases in proportion to the dose, hallucinations, agitation, nightmares; infrequently - confusion, irritability; frequency is unknown - impaired consciousness, dysphoria, aggressiveness, visual and auditory hallucinations, irritability, behavioral reactions, somnambulism, drug dependence (may develop even when using therapeutic doses), when the drug is discontinued - withdrawal syndrome or rebound insomnia, decreased libido, gait disturbance , ataxia, falls (mainly in elderly patients), addiction to the drug (decrease in sedative and hypnotic effect when used for several weeks). Most side effects on the part of the psyche are paradoxical reactions.
From the digestive system: often - diarrhea, nausea, vomiting, abdominal pain; frequency unknown - increased activity of liver enzymes.
From the musculoskeletal system: the frequency is unknown - muscle weakness.
On the part of the skin: the frequency is unknown - rash, itching, urticaria, hyperhidrosis.
Allergic reactions: frequency unknown - angioedema.
Other: often - a feeling of fatigue; infrequently - diplopia.
Contraindications for use
- acute and / or severe respiratory failure
- severe acute or chronic liver failure
- sleep apnea (including suspected)
- due to the presence of lactose in the composition: hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome
- pregnancy
- lactation period
- children's age (up to 18 years)
- hypersensitivity to zolpidem or any other component of the drug
With caution: severe myasthenia gravis, respiratory failure, liver failure of mild to moderate severity, depression, alcoholism, drug addiction and other types of addiction.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation.
Application for violations of liver function
Contraindicated in acute or chronic liver failure.
With caution: liver failure of mild to moderate severity.
In case of impaired liver function, treatment begins with a dose of 5 mg. If necessary (insufficient clinical effect) and good tolerability of the drug, the dose can be increased to 10 mg. The maximum daily dose is 10 mg. The course of treatment should not exceed 4 weeks. With transient insomnia, the recommended course of treatment is 2-5 days, with situational insomnia - 2-3 weeks.
Use in elderly patients
In elderly patients, treatment begins with a dose of 5 mg. If necessary (insufficient clinical effect) and good tolerability of the drug, the dose can be increased to 10 mg. The maximum daily dose is 10 mg. The course of treatment should not exceed 4 weeks. With transient insomnia, the recommended course of treatment is 2-5 days, with situational insomnia - 2-3 weeks.
In elderly patients, mental and behavioral (including paradoxical) reactions may occur. If such reactions occur, zolpidem should be discontinued.
In elderly patients or with impaired liver function, a significant increase in T1 / 2 of zolpidem is possible, which can lead to cumulation of the drug when it is taken again.
When using zolpidem in the elderly, care must be taken due to the risk of developing pronounced sedative and / or muscle relaxant effects.
Special instructions
Persistence of insomnia during 7-14 days of treatment indicates the presence of primary mental disorders and / or disorders of the nervous system. Therefore, to identify these disorders, it is necessary to regularly reassess the patient's condition.
To reduce the risk of developing anterograde amnesia, patients should have the conditions for uninterrupted 7-8 hours of sleep.
When using zolpidem, mental and behavioral (including paradoxical) reactions may occur (the risk of development is higher in elderly patients). If such reactions occur, zolpidem should be discontinued. After a course of administration for several weeks, there may be some decrease in the sedative and hypnotic effects of zolpidem.
The use of zolpidem (especially long-term) can lead to the formation of physical and / or mental dependence, the risk of which increases with increasing dose and duration of treatment, as well as in patients with a history of alcohol abuse or other drugs and non-drug substances. Such patients during the period of treatment should be under close supervision. However, dependence (very rarely) can also occur at therapeutic doses and/or in patients without individual risk factors.
The combination of zolpidem with benzodiazepines increases the risk of developing drug dependence.
In elderly patients or with impaired liver function, a significant increase in T1 / 2 of zolpidem is possible, which can lead to cumulation of the drug when it is taken again. Based on the characteristics of the pharmacokinetics of zolpidem, cumulation of the drug is not expected in chronic renal failure.
When using zolpidem in the elderly, care must be taken due to the risk of developing pronounced sedative and / or muscle relaxant effects.
Influence on the ability to drive vehicles and mechanisms
During the period of treatment should refrain from engaging in potentially hazardous activities that require increased concentration of attention (driving a car, working with mechanisms) and the speed of psychomotor reactions.
Overdose
Symptoms: impaired consciousness (from confusion and lethargy to coma), ataxia, lowering blood pressure, respiratory depression.
Treatment: induction of vomiting within 1 hour after an overdose, activated charcoal, if more than 1 hour has passed after an overdose (with preserved consciousness - inside, with unconsciousness - through a tube), gastric lavage, symptomatic therapy. Flumazenil (a benzodiazepine receptor antagonist) is recommended as an antidote, but it should be remembered that benzodiazepine receptor antagonism can lead to the development of seizures, especially in patients with epilepsy. Dialysis is ineffective.
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Drug interactions
Not recommended combinations: ethanol enhances the sedative effect of zolpidem.
Combinations requiring caution when using:
- drugs that depress the central nervous system (neuroleptics, barbiturates, other hypnotics, anxiolytics / sedatives, antidepressants with a sedative effect, narcotic analgesics, antitussives of the central action), antiepileptics, drugs for general anesthesia, antihistamines with a sedative effect, hypotensive central action; baclofen; thalidomide; pizotifen - increased inhibitory effect on the central nervous system and the risk of respiratory depression;
- buprenorphine - risk of respiratory depression;
- ketoconazole (a potent inhibitor of CYP3A4) at a dose of 200 mg 2 times / day increases T1 / 2, AUC and reduces the clearance of zolpidem (possibly increased sedative effect of zolpidem);
- itraconazole (CYP3A4 inhibitor) - a slight, clinically insignificant change in the pharmacokinetics and pharmacodynamics of zolpidem.
Interactions to be taken into account:
- rifampicin (CYP3A4 inducer) - accelerates metabolism, reduces the concentration and, as a result, the effectiveness of zolpidem.
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