Imovan
Imovan: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Imovane
ATX code: N05CF01
Active ingredient: zopiclone (zopiclone)
Producer: Sanofi Winthrop Industrie (France)
Description and photo update: 2019-20-08
Prices in pharmacies: from 252 rubles.
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Imovan is a drug used for insomnia.
Release form and composition
Imovan is produced in the form of film-coated tablets: white, oval, with a risk on one side (10 pieces in blisters, 2 blisters in a cardboard box; 20 pieces in blisters, 1 blister in a cardboard box).
The composition of 1 tablet includes:
- Active ingredient: zopiclone - 7.5 mg;
- Auxiliary components: calcium hydrogen phosphate dihydrate - 60 mg; wheat starch - 60 mg; sodium carboxymethyl starch (type A) - 4.95 mg; lactose monohydrate - 31.575 mg; magnesium stearate - 0.975 mg.
Shell composition: titanium dioxide (E171) - 1.65 mg; hypromellose - 4.95 mg; macrogol 6000 - 1.65 mg (ready-made mixture "Opadry OY-S-38906" - 8.25 mg can be used for coating a tablet).
Pharmacological properties
Pharmacodynamics
Imovan, by decision of the Standing Committee on Drug Control (PCCN), was assigned to List No. 1 of potent substances.
The active ingredient of the drug is zopiclone, a hypnotic from the group of cyclopirrolones, structurally different from barbiturates and benzodiazepines. Pharmacological properties of zopiclone: hypnotic, sedative, tranquilizing, anticonvulsant and muscle relaxant. These effects are associated with a specific agonistic effect on omega receptors (benzodiazepine receptors type I and II), related to the macromolecular receptor complex GABA (γ-aminobutyric acid) -omega, which modulates the opening of neuronal ion channels for chlorine.
Zopiclone reduces the time to falling asleep, the frequency of night / early awakenings, increases the duration of sleep, improves its quality and makes it easier to awaken. As a result of the use of Imovan in the recommended doses, these effects are combined with a specific electroencephalographic profile, which differs from that recorded due to the administration of benzodiazepines. According to polysomnography data, zopiclone shortens the first phase and prolongs the second phase of sleep in patients with insomnia, while maintaining or prolonging the third and fourth stages of deep sleep and the time of REM sleep.
According to clinical studies of the withdrawal syndrome using polysomnogram registration, significant rebound insomnia was not objectively detected even after 28 days of taking zopiclone. According to the results of other observations, the absence of the withdrawal of the hypnotic effect was recorded while taking Imovan for up to 17 weeks.
Pharmacokinetics
- absorption: zopiclone is absorbed quickly, the maximum plasma concentration (Cmax) after oral administration of 3.75 mg and 7.5 mg of the substance is achieved within 1.5-2 hours and is approximately 30 and 60 ng / ml, respectively; the level of absorption of the drug does not depend on the diet and gender of the patient;
- distribution: the connection of zopiclone with blood plasma proteins is about 45%;
- metabolism: the main metabolites of zopiclone are a pharmacologically active N-oxide derivative and a pharmacologically inactive N-desmethyl metabolite. Their half-life (T 1/2) is about 4.5 and 7.4 hours, respectively. As a result of repeated administrations, zopiclone and its metabolites do not accumulate; interindividual variability is negligible;
- excretion: if the dosage regimen for unchanged zopiclone T 1/2 is observed, it is about 5 hours. It is excreted in the urine ~ 80% (mainly in the form of metabolites) and with feces ~ 16%.
Indications for use
According to the instructions, Imovan is prescribed for the treatment of insomnia in adults (transient, chronic and situational), including difficulty falling asleep, early and nocturnal awakenings.
Contraindications
- Severe respiratory failure;
- Sleep apnea;
- Severe liver failure;
- Severe myasthenia gravis;
- Age under 18;
- Hypersensitivity to drug components.
Reception of Imovan is not recommended for lactating and pregnant women.
Instructions for use of Imovan: method and dosage
Imovan tablets are taken orally, before bedtime.
Therapy should be carried out as short as possible (no longer than 1 month). After re-evaluating the patient's condition, an increase in the duration of treatment is possible.
The recommended adult daily dose is 7.5 mg (exceeding this dose is not recommended). The average duration of Imovan's use is:
- Transient insomnia - 2-5 days;
- Situational insomnia - 14-21 days.
When treating chronic insomnia, the duration of the drug intake is determined by the doctor individually.
Elderly patients, as well as patients with functional disorders of the liver, renal failure or chronic pulmonary insufficiency, therapy should be started with 3.75 mg Imovan. If necessary, it is possible to double the daily dose.
Side effects
Most often, when taking Imovan tablets, a bitter taste appears in the mouth.
In addition, during therapy, it is possible for the development of disorders on the part of some body systems, manifested with different frequencies:
- Digestive system: dyspepsia, dry mouth, nausea; in isolated cases - a slight increase in the activity of hepatic transaminases and / or alkaline phosphatase in the blood serum;
- Central nervous system: residual drowsiness upon awakening, headache, dizziness, anterograde amnesia; rarely - a depressive state, hallucinations, nightmares, confusion, irritability, aggressiveness, confusion, impaired coordination of movements, depressed mood, inappropriate behavior with the possible development of amnesia;
- Allergic reactions: rash, itchy skin; extremely rare - anaphylactic reactions, angioedema.
After stopping therapy, a withdrawal syndrome may occur, manifested by symptoms such as tremor, irritability, hallucinations, rebound insomnia, anxiety, trembling, excessive sweating, agitation, headache, confusion, delirium, tachycardia, nightmares; very rarely - seizures.
Overdose
Overdose of zopiclone usually manifests itself as symptoms of central nervous system depression of varying severity, from drowsiness to coma, depending on the dose taken. In the case of a mild overdose, drowsiness, confusion, lethargy appear. With a more serious excess of the dose of Imovan, the development of ataxia, muscle hypotension, a decrease in blood pressure, methemoglobinemia, respiratory depression and coma is possible. An overdose does not pose a potential danger to the patient's life if Imovan's reception is not combined with other drugs that depress the central nervous system (for example, ethanol). Other risk factors that can aggravate symptoms, and even in extremely rare cases lead to death, are concomitant diseases and a weakened condition of the patient.
If after taking Imovan a little time has passed, the patient should be rinsed out the stomach and given enterosorbents (for example, activated carbon). If necessary, it is recommended to carry out symptomatic and supportive treatment in a hospital setting. Attention should be focused on the functions of the cardiovascular and respiratory systems.
Hemodialysis is not effective enough due to the high Vd (volume of distribution) of zopiclone. Flumazenil is recommended as an antidote.
special instructions
While taking Imovan, it should be remembered that despite the slight risk, there is a possibility of developing addiction to and abuse of zopiclone. The risk of abuse or dependence arises with violations of the dose and duration of therapy, abuse of drugs and / or alcohol, concomitant use with other psychotropic drugs or alcohol.
The risk of withdrawal syndrome and rebound insomnia after abrupt discontinuation of therapy, especially after prolonged use of Imovan, cannot be ruled out. As a consequence, the dose of the drug should be reduced gradually.
A drug for the treatment of depression should not be used (it may mask its symptoms).
During therapy, anterograde amnesia may occur, especially after a significant period of time between taking Imovan and going to bed or when sleep is interrupted. The risk of developing this disorder is reduced by taking the drug immediately before bedtime and ensuring the duration of sleep is at least 6 hours.
Imovan may impair the ability to drive vehicles and perform work with mechanisms, therefore, during the period of therapy, the patient is advised to refrain from such activities.
Application during pregnancy and lactation
To assess the safety of Imovan's use in pregnant and lactating women, there are not enough clinical data.
No adverse effects on the fetus were found in the study of the reproductive toxicity of zopiclone in 3 animal species. But due to the fact that studies of reproductive function in animals do not always correspond to the reaction to the drug during human pregnancy, the use of Imovan is not recommended for pregnant women.
Taking zopiclone in the third trimester of pregnancy or during childbirth, as a result of the pharmacological effects of the drug, can cause hypothermia, muscle hypotension and respiratory depression in the newborn.
If taking Imovan during pregnancy is necessary for vital reasons, the course of drug therapy should be as short as possible, not exceed 4 weeks together with a period of gradual dose reduction. Children born to mothers who received sedative (sleeping pills) for a long time in late pregnancy are prone to the development of physical dependence and the risk of developing withdrawal syndrome in the postnatal period.
Women of childbearing age should be warned that when planning pregnancy or suspecting it, it is necessary to consult a specialist on the issue of stopping / continuing taking the drug.
Despite the insignificant concentration of zopiclone in breast milk, the use of Imovan is contraindicated during lactation.
Pediatric use
Children and adolescents under 18 years of age are not prescribed drugs containing zopiclone.
With impaired renal function
In patients with renal insufficiency, no accumulation of zopiclone or its metabolites was found even after prolonged therapy. Despite this, it is recommended to start treatment in such patients with a dose of 3.75 mg.
For violations of liver function
In patients with cirrhosis of the liver, the clearance of zopiclone decreases by approximately 40%, in accordance with the weakening of the demethylation process. With a severe degree of impairment of hepatic function, the use of Imovan is contraindicated.
In case of liver dysfunction, therapy is recommended to start with a dose of 3.75 mg, gradually increasing it, if necessary, to 7.5 mg.
Use in the elderly
In elderly patients, taking into account a slight decrease in hepatic metabolism and an extension of T 1/2 ~ up to 7 hours, no accumulation of zopiclone was detected in the plasma even after repeated administration of Imovan.
It is recommended to start therapy in elderly patients with a dose of 3.75 mg, gradually increasing it, if necessary, to 7.5 mg.
Drug interactions
Simultaneous administration of Imovan with alcohol is not recommended, as this may increase the sedative effect of the drug.
When Imovan is used together with some drugs, undesirable effects may occur:
- Erythromycin, antipsychotics, hypnotics, antiepileptic and sedatives, tranquilizers, antidepressants, opioid analgesics, anesthetics, antihistamines with a sedative effect: increasing the depressing effect on the central nervous system;
- Trimipramine: decrease in its concentration in plasma and the effect of its use;
- Inhibitors of the CYP3A4 isoenzyme (ritonavir, clarithromycin, erythromycin, ketoconazole): increased plasma concentration of zopiclone;
- Inducers of the CYP3A4 isoenzyme (carbamazepine, rifampicin, phenobarbital, phenytoin): a decrease in the concentration of zopiclone in plasma.
Analogs
Imovan's analogues are: Zopiclone, Zopiclone 7,5-SL, Zolinox, Thorson, Normason, Somnol, Sonnat, Sonovan, Piklon.
Terms and conditions of storage
Store in a dry place out of reach of children at temperatures up to 30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Imovan
According to the majority of patients, Imovan can be considered one of the best sleeping pills, reviews about him are mostly positive. The drug is inexpensive, effective, sparing fast action, providing sound healthy sleep. To achieve maximum therapeutic efficacy, experts advise to carefully select the dose and adhere to the prescribed dosage regimen, which will alleviate adverse reactions and avoid addiction.
Price for Imovan in pharmacies
The approximate price of Imovan (film-coated tablets) is for 20 pcs. in the package varies from 250 to 300 rubles.
Imovan: prices in online pharmacies
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Drug name Price Pharmacy |
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Imovan 7.5 mg film-coated tablets 20 pcs. 252 RUB Buy |
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!
