Zolpidem - Instructions For The Use Of Tablets, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Zolpidem

Zolpidem: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Zolpidem

ATX code: N05CF02

Active ingredient: Zolpidem (Zolpidem)

Producer: SA Laboratorios BAGÓ (Argentina)

Description and photo update: 18.10.2018

Zolpidem is a drug with a hypnotic effect.

Release form and composition

Dosage form of release - tablets: white, round, flat, with a chamfer and a line, on one side - engraving NOC, on the other - the company logo (15 pcs. In blisters, in a cardboard box 1 or 2 packs).

Composition of 1 tablet:

• active substance: zolpidem tartrate - 10 mg;
• auxiliary components: colloidal silicon dioxide, magnesium stearate, talc, lactose monohydrate, microcrystalline cellulose.

Pharmacological properties

Pharmacodynamics

Zolpidem is a hypnotic belonging to the group of imidazopyridines. It is a selective agonist of the omega1-benzodiazepine receptor subclass.

When used in therapeutic doses, it has a sedative effect without exerting anxiolytic, anticonvulsant and central muscle relaxant effects. Excites benzodiazepine receptors (omega) in the alpha subunit of GABA-receptor complexes, which are localized in the region IV of the plate of the sensory-motor zones of the cortex, pons, globus pallidus, optic hillocks of the ventral thalamic complex, reticular parts of the substantia nigra, etc.

The use of the drug helps to shorten the time to fall asleep, reduce the number of night awakenings, increase the total duration of sleep and improve its quality. There is a lengthening of the II stage of sleep and the stage of deep sleep (III and IV).

During the day, the agent does not cause drowsiness.

Pharmacokinetics

The absorption of zolpidem from the gastrointestinal tract is rapid. After oral administration, the time to reach C _max in blood plasma ranges from 0.5 to 3 hours. Plasma protein binding - 92%, bioavailability - 70%. There is a linear relationship between the dose of the drug and its plasma concentration.

It is metabolized in the liver by the formation of three inactive metabolites, which are excreted through the intestines and kidneys (37% and 56%, respectively). The average elimination half-life is 2.4 hours. V _d is in the range of 0.5 ± 0.02 l / kg.

Does not induce liver enzymes.

In small amounts excreted in breast milk.

In elderly patients, plasma clearance in the blood can decrease without a significant increase in the half-life, while the C _max increases by 50%. With pronounced impaired renal function, there is a slight increase in clearance, hepatic - an increase in bioavailability and half-life.

Indications for use

Zolpidem is prescribed for the treatment of sleep disorders, including difficulty falling asleep, night / early awakening.

Contraindications

Absolute:

• liver failure (chronic or severe acute);
• respiratory failure (acute and / or severe);
• sleep apnea, including presumed sleep apnea;
• hereditary lactose intolerance, glucose-galactose malabsorption syndrome or lactase deficiency (Zolpidem contains lactose);
• pregnancy and the period of breastfeeding;
• age up to 18 years;
• individual intolerance to the components of the drug.

Relative (diseases / conditions in the presence of which caution is required):

• severe myasthenia gravis;
• mild / moderate hepatic impairment;
• respiratory failure;
• drug addiction, alcoholism and other types of addiction;
• depression.

Instructions for the use of Zolpidem: method and dosage

The tablets are taken orally, just before bedtime.

Single dose - 10 mg. In weakened / elderly patients, with impaired hepatic function, therapy should be started with a dose of 5 mg, with insufficient clinical effect and good tolerance, it can be further increased to 10 mg.

The maximum is 10 mg per day.

The recommended course duration for transient insomnia is 2–5 days, for situational insomnia - from 2 to 3 weeks. The maximum duration of therapy is 4 weeks.

If the treatment is carried out in a very short course, gradual withdrawal of the drug is not required. In cases of prolonged use, Zolpidem should be withdrawn gradually, which will reduce the likelihood of rebound insomnia.

Side effects

The drug is generally well tolerated.

Possible adverse reactions (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; with an unknown frequency - if it is impossible to estimate the frequency occurrence of violations):

• nervous system: often - nightmares, increased insomnia, drowsiness, headache, drunkenness, dizziness, anterograde amnesia (possibly association of the effects of amnesia with behavioral reactions; the risk of its occurrence increases in proportion to the dose), agitation, hallucinations; infrequently - irritability, confusion; with an unknown frequency - impaired consciousness, aggressiveness, somnambulism, dysphoria, auditory / visual hallucinations, behavioral reactions, hyperexcitability, drug dependence (can be observed even with the use of Zolpidem in therapeutic doses); when therapy is discontinued - rebound insomnia or withdrawal syndrome, gait disturbance, decreased libido, ataxia, falls (usually in elderly patients),addiction to the drug (decrease in hypnotic / sedative effect when used for several weeks); in most cases, the side reactions of the psyche are paradoxical reactions;
• musculoskeletal system: with unknown frequency - muscle weakness;
• digestive system: often - abdominal pain, vomiting, diarrhea, nausea; with an unknown frequency - an increase in the activity of liver enzymes;
• allergic reactions: with an unknown frequency - angioedema;
• skin: with an unknown frequency - rash, urticaria, itching, hyperhidrosis;
• others: often - feeling tired; infrequently - diplopia.

Overdose

The main symptoms: impaired consciousness (from lethargy and confusion to coma), lowering blood pressure, ataxia, respiratory depression.

Therapy: within 1 hour after overdose - induction of vomiting; activated charcoal, if more than 1 hour has passed (with preserved consciousness - inside, with unconscious - through a probe), gastric lavage, symptomatic treatment. Dialysis is ineffective. Flumazenil is recommended as an antidote, but it must be borne in mind that antagonism with benzodiazepine receptors can lead to seizures, especially in epilepsy.

special instructions

If the symptoms of insomnia persist for 7-14 days after the start of Zolpidem use, this may indicate the presence of disorders of the nervous system and / or primary mental disorders. In order to identify such violations, it is required to carry out a regular reassessment of the patient's condition.

To reduce the likelihood of anterograde amnesia, patients should be able to sleep continuously for 7–8 hours.

During the period of therapy, the development of mental and behavioral (including paradoxical) reactions is possible, while a higher risk is observed in elderly patients. With the development of such disorders, the drug is canceled. It should be taken into account that after a course of administration lasting several weeks, some reduction in the hypnotic and sedative effects of Zolpidem is possible.

The use of the drug (especially long-term) can lead to the formation of mental / physical dependence, the risk of which increases with an increase in the duration of treatment and dose, as well as in patients with a burdened history of alcohol or other drugs / non-drug abuse. The condition of such patients during the period of Zolpidem application should be carefully monitored. It is also necessary to take into account the likelihood of dependence (in extremely rare cases) and when using therapeutic doses of the drug. The risk of drug dependence increases with the combined use of Zolpidem and benzodiazepines.

In elderly patients or in the presence of impaired hepatic function, a significant increase in the half-life of Zolpidem may be observed, which can cause the accumulation of the active substance when it is repeated (in chronic renal failure, the accumulation of the drug is not expected).

Influence on the ability to drive vehicles and complex mechanisms

Patients should refrain from driving vehicles during the period of therapy.

Application during pregnancy and lactation

According to the instructions, Zolpidem is contraindicated for use during pregnancy and breastfeeding.

Pediatric use

Age under 18 is a contraindication for therapy.

For violations of liver function

• mild / moderate: Zolpidem is prescribed with caution;
• severe course: therapy is contraindicated.

Use in the elderly

When prescribing Zolpidem to elderly patients, caution is required, since they have an increased risk of a pronounced muscle relaxant / sedative effect.

Drug interactions

Ethanol enhances the sedative effect of Zolpidem, so this combination is not recommended.

When combined with rifampicin, an acceleration of metabolism, a decrease in concentration and, as a consequence, the effectiveness of Zolpidem can be observed (must be taken into account).

Combinations requiring caution:

• drugs that depress the central nervous system (including barbiturates, antipsychotics, other hypnotics, narcotic analgesics, anxiolytics / sedatives, central antitussives, antidepressants with sedative effects), antihypertensive central action, antihistamines with sedation, drugs for general anesthesia, drugs with anti action, baclofen, pizotifen, thalidomide: increasing the depressing effect on the central nervous system and increasing the likelihood of respiratory depression;
• ketoconazole: increased sedative effect of zolpidem;
• buprenorphine: increased likelihood of respiratory depression.

Analogs

Zolpidem's analogs are: Zolsana, Ivadal, Snovitel, Nitrest, Oniria, Sanval.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Zolpidem

Reviews about Zolpidem are mostly positive. When used in therapeutic doses, its rather high efficiency is noted, allowing you to get enough sleep after stress.

Adverse reactions develop infrequently, as a rule, with non-compliance with the dosage regimen and the presence of hypersensitivity to the active substance. The most common of these are hallucinations, nausea, dizziness, and headaches. When combined with alcohol, addiction occurs faster, and it becomes difficult to calculate the dosage.

The price of Zolpidem in pharmacies

The price of Zolpidem is unknown because the drug is not available in pharmacies.

Group analogues are available (approximate price):

• Nitrest (20 tablets 10 mg): in the range from 1000 to 1200 rubles;
• Sanval (20 tablets 10 mg): in the range from 2300 to 2800 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!