The zoplic tablet contains 7.5 milligrams of the active drug connection of the same name. In addition, such auxiliary components as: microcrystalline cellulose, lactose monohydrate, potato starch, anhydrous silicon dioxide colloid, magnesium stearate , as well as talc, Aerosil and Pisidon .

Form release

This drug is produced in the form of tablets, on top of which a special shell is applied, as well as powder, packaged in special sachets.

pharmachologic effect

Drug applies to sedative and sleeping preparations, in group Pyrrolopirazinids .

Pharmacodynamics and pharmacokinetics

As zopiklon is slytopower cycopyrrolone derivative, The drug belongs to effective agonists so-called benzodiazepine receptors . This medicine is distinguished pronounced anxiolytic, as well as sedative exposure . In addition, LS stands out for their amnesian, anticonvulsant and muscular relaxing properties.

Thanks to the chemical characteristics of the drug in the drug zopylic , Strengthening GABA-ERGISS PROCESSES in the brain man, thereby increasing the threshold of sensitivity to medicator GABA receptors Due to the interaction active ingredients from benzodiazepine receptors. When taking it drug The number of awakening during night sleep is reduced.

In addition, the drug has a beneficial effect on the flood process and significantly increases sleep duration. It is worth noting that drug Treatment It does not have a negative impact on the very structure of sleep, i.e. Does not change its stages, for example, does not reduce the duration of fast sleep and so on. The drug quickly dissolves in stomach and reaches its maximum concentration after a few hours after its reception.

The drug easily overcomes histohematic barrier and evenly distributed in the tissues and organs human organism, Including in the brain. With a re-course of treatment Zopiklon cumulation Not manifest. For half an hour after using the drug, a strong dream occurs, the duration of which is the maximum of eight hours.

It is worth noting that with simultaneous reception of zopylic and medicines containing in the composition teophyllin , patients with significantly decreases the duration, and, in addition, the intensity of asthmatic seizures in the preliminary clock.

Indications for use

As a rule, the drug is prescribed with the following sleep disorders:

• difficulty falling asleep;
• constant night or morning awakening;
• , including chronic, short-term or situational kinds of indisposition;
• restless sleep;
• sleep disorders associated with various species Mental disorders.

Contraindications

Absolute contraindications include:

• respiratory failure;
• age up to 18 years;

In addition, with extreme caution should use this preparation patients with hepatic insufficiency when malabsorption Galactose and glucose, with innate Galaktosemia , when, as well as lactase deficiency .

Side effects

With the correct dosage of the drug usually side effects Zopyclone do not manifest. However, with a significant excess of dosages, the following ailments may arise:

• behavior disorders;
• aggressiveness;
• somnambulism;
• confusion or change of consciousness;
• psychological or physiological dependence;
• speech disorders;
• coordination violation;
• reduction of sexual attraction;
• rash on the skin;
• diplopia;
• hypotension;
• and other manifestations of allergies;
• asthenia;
• dispersion;
• hypotension;
• vomiting;
• reduced mass.

It is worth noting that when overdose, patients feel Dry mouth and bitter taste . In some cases it may increase activity of hepatic enzymes .

Instructions for use of zoplic (method and dosage)

Therapeutic (medium) dose of the drug in accordance with the instructions for zopiclon (zopiClone) is 7.5 mg., Which corresponds to one tablet. The drug is accepted immediately before bedtime. With severe forms insomnia The dosage can be enlarged twice. However, patients in old age and people suffering from violations functions of the liver Do not take more than 3.75 mg. Zoplic per day.

Overdose

The drug overdose occurs in the event of exceeding the recommended average therapeutic doses of the drug and can threaten the patient's life. As a rule, in case of overdose occurs Depression of the Central CNS (central nervous system). Signs of overdose can be considered the sluggish condition of the patient , as well as , confusion of consciousness, inhibition of breathing, hypotension and hypotension.

If no more than an hour has passed since the reception of the drug, then you can call a patient vomot . In other cases, you should immediately hold stomach washing , while paying special attention to the protection breath organs . In order to reduce absorption Patients contained in the drug discharge.

Interaction

Zopiclon is forbidden to be taken simultaneously with alcoholic beverages, as well as alcohol-containing drugs. In addition, the drug reduces efficiency Trimipramine and enhances the oppressive impact on nervous system Drugs possessing anxiolytic, antidepressant, antihistamine, sedative, anticonvulsant , as well as antipsychotropic effect.

Terms of sale

Synonyms zopylicon

Children

During pregnancy (and lactation)

The drug is forbidden to take in the period lactation or during pregnancy .

Zopiclon is the first representative of the new class of psychotropic drugs, sedative and sleeping pills are due high degree affinities for binding places on the receptor complex GABA in the central nervous system.

After taking the drug, a sleep comes quickly, characterized by a normal phase structure and durability. In this case, the duration of the fast sleep phase is not reduced.

It is a sleeping pill from a group of cyclopyron derivatives, has a sedative, amnetic, anxiolytic and anticonvulsant action. Interacting with benzodiazepine receptors, it enhances GABA-Ergic processes in the brain, increasing the sensitivity of the receptor to the mediator.

After taking inside, it is quickly absorbed from the stomach, distributing throughout the body, including in the brain. The maximum concentration of the active substance in the blood is achieved after 1-3 hours.

Indications for use

What does zopiklon help? According to the instructions, the drug is prescribed in the following cases:

• difficulty falling asleep;
• constant night or morning awakening;
• insomnia, including chronic, short-term or situational harassment types;
• restless sleep;
• sleep disorders associated with various types of mental disorders.

Instructions for use zopiklon, dosage

The tablet takes inside before bedtime (in 30 minutes) drinking water.

Standard dosages according to the instructions - 1 tablet zopiklon 7.5 mg per day. With severe insomnia forms, the dosage can be increased twice.

Maximum dosage - 15 mg \\ 2 tablets.

Elderly patients and people suffering from liver disorders - maximum dosage of 3.75 mg (half tablets).

special instructions

Applications should be avoided during pregnancy and breastfeeding. It is necessary to refrain from performing potentially dangerous species Activities requiring increased attention.

A sharp cessation of treatment does not cause the development of cancellation syndrome.

During treatment, alcohol and reception of deprimating psychotropic drugs should be avoided. In cases of applying a zopyclone during myasthenia, it is necessary to ensure strict neurological control due to the possible enhancement of muscle weakness.

Side effects

The instruction warns the possibility of the development of the following side effects when appointing zopiclon:

• From the gearbox: metal or bitter taste in the mouth, dry throat, vomiting, nausea.
• From the CNS: drowsiness, headache, dizziness, hallucinations, confusion of consciousness, anterograd amnesia, nightmares.
• From the skin: rash, irritation.

Contraindications

Contraindicated to appoint zopiklon in the following cases:

• hypersensitivity to the components of the drug;
• severe respiratory failure;
• pregnancy and lactation;
• children under 15 years old.

Patients with severe liver failure are prescribed with extreme caution.

Overdose

Overdose is manifested by a deep long sleep. Conduct supportive and symptomatic treatment.

Zopiclon, price in pharmacies

If necessary, it is possible to replace zopiklon to analogue according to the active substance - these are drugs:

1. Injured
2. Relaxone
3. Solinox
4. Somnol
5. Plodorm
6. Tryson.

When choosing analogues, it is important to understand that the instruction on the use of zopiclon, the price and reviews for drugs of similar action do not apply. It is important to obtain a doctor's advice and not to produce an independent replacement of the drug.

Price in the pharmacies of Russia: the medicine is removed from production, with the same active substance You can buy tablets 7.5mg 20 pcs - from 245 to 302 rubles, according to 482 pharmacies.

Store in the light protected, inaccessible for children. room temperature. Shelf life - 2 years. Conditions of vacation from pharmacies - by recipe.

Round tablets covered with green shell, bico shape.

Structure

Each tablet zopiclon-LF contains:

active substance:zopiclon - 7.5 mg.

excipients:cellulose microcrystalline, sodium starch glycol (type A), magnesium stearate, calcium hydrophosphate dihydrate, lactose monohydrate, Oddraya II (green) (polyvinyl alcohol partially hydrolyzed, titanium Dioxide E 171, macrogol / peg, talc, indigoline aluminum hydroxide E 132, quinoline yellow Aluminum varnish E 104).

Form release

Sheath-covered tablets.

Pharmacotherapeutic group

Psycheptics. Sad and sedatives. Benzodiazepine-like funds.

The codeATX: N05CF01

Pharmacological properties

Zopiclon is a sleeping pills that quickly initiates and supports sleep without reducing the total paradoxical sleep and retains a slow dream. The next morning, after applying the zopylic, there are minor residual effects. Pharmacological properties Zopilon include sleeping pills, sedative, anxiolytic, anticonvulsant and mineral actions.

Indications for use

Zopiclon is used to treat the following problems with a dream in adults:

• difficulties with falling asleep;
• night awakening;
• early awakening;
• heavy sleep disorders.

Zopiclon can be used to treat both temporary and chronic insomnia. However, Zopiklon is not intended for daily use over a long period of time or for the treatment of depression.

If you have doubts or questions, consult with your doctor.

Method of application and dose

Inside, not chewing and not resolving, immediately before bedtime.

Dose should be selected depending on the age of the patient, body weight, general status Health and type of insomnia. Treatment should be started with the smallest effective dose.

Adults under the age of 65: 7.5 mg once a day.

Patients with impaired kidney function: the accumulation of zoplic and its metabolites was not detected in the treatment of insomnia in patients with renal failure. Nevertheless, the treatment of such patients is recommended to start with a dose of 3.75 mg.

Patients with impaired liver function: Since patients with impaired liver function can be reduced to the removal of zoplic, the recommended dose is 3.75 mg. The dose of 7.5 mg can be applied with caution only in exceptional cases, depending on the efficiency and portability of the drug.

Patients with chronic pulmonary failure: The recommended initial dose is 3.75 mg, if necessary, a dose can be increased to 7.5 mg.

In all cases, the dose should not exceed 7.5 mg per day.

Children

Zopiclon should not be used in children under 18 years old. The safety and efficiency of the application of the zopilo in children under 18 is not installed.

Duration of treatment

Treatment should be short-lived, starting from several days to 2-4 weeks (maximum), including a dose reduction period.

Slightly insomnia (for example, during the journey) - 2-5 days, short-term insomnia - 2-3 weeks.

If it is necessary to use a low dose, it is recommended to use other drugs containing, zopiclon.

Before the beginning of the use of the drug, patients should clarify that the therapy should not be long and how to gradually stop. The gradual cessation of treatment reduces the risk of renewal of insomnia.

To reduce anxiety, possibly associated with the cessation of drug use, the patient must be warned about the possibility of resuming insomnia after the cessation of treatment.

When passing the next reception of the drug must be taken. But one should not apply the dual dose of the drug to replace the missed one. Continue the reception of the drug should follow the recommendations of the doctor.

If you have doubts or questions, contact your doctor.

Side effect

Most often observed unwanted reaction - bitter or metal taste in the mouth. Other possible unwanted reactions are indicated below. Their appearance is associated with individual sensitivity, more often are observed within an hour after use, if the patient is immediately sent to bed and does not fall asleep.

In the future, the listed side effects are ordered according to the classification of groups of organs and the MEDDRA system groups: very often (\u003e 1/10), often (\u003e 1/100 to<1/10), нечасто (>1/1 000 T.<1/100), редко (>1/10 000 BC<1/1 000), очень редко (<1/10 000), частота неизвестна (невозможно определить частоту по имеющимся данным).

Impaired immune system: Very rarely - angioedema swelling, anaphylactic reactions.

Disorders of the psyche: Infrequently - nightmares, excitement; rarely - confusion of consciousness, decreased libido, irritability, aggressiveness, hallucination; The frequency of unknown is anxiety, delirium, angiveness, depressed mood, inadequate behavior (possibly associated with amnesia) and somnambulism, dependence, cancellation syndrome.

Nervous System Violations: often - disgusting (bitter taste in the mouth), residual drowsiness; Infrequently - dizziness, headache; rarely - antitegrand amnesia (risk increases with increasing dose; in some cases, it is additionally possible to observe violations of behavior); The frequency is unknown - ataxia, paresthesia.

Violations: The frequency is unknown - diplopia.

Violations by the respiratory system, organs of the chest and mediastinum: rarely - shortness of breath; The frequency is unknown - the oppression of breathing.

Violations from the gastrointestinal tract: often - dry mouth, infrequent - nausea, vomiting; Frequency unknown - dyspepsia.

Violations by the liver and biliary tract: Very rarely - easy or moderate increase in transaminase and / or alkaline phosphatase in plasma.

Disturbing from the skin and subcutaneous fabrics: Rarely - urticaria or rash, itching.

Violations by skeletal and muscular and connective tissue: The frequency is unknown - muscle weakness.

General disorders and disorders at the injection site: The frequency is unknown - weakness.

Injuries, intoxication, complications of manipulations: rarely - drops (mainly in older patients).

There are reports that after stopping the reception of the zopyl, the abstineent syndrome develops, the symptoms of which vary and can manifest themselves in the form of "ricoce" insomnia, pain in muscles, anxiety, tremor, sweating, excitement, confusion, headache, heartbeat, tachycardia, delirium, hallucinations , nightmares, panic attacks, muscle seizures, gastrointestinal disorders and irritability. In severe cases, the following symptoms may occur: Derealization, depersonalization, hyperactus, numbness and tingling in the limbs, increased sensitivity to light and noise, tactile hyperesthesia, hallucinations. In very rare cases, convulsions are possible.

In the event of adverse reactions, including those not specified in this manual, it is necessary to stop the reception of the drug and consult a doctor.

Contraindications

• increased sensitivity to zopiclon or any of the auxiliary drug components;
• severe respiratory failure;
• severe liver failure;
• night apnea syndrome;
• miasti;
• pregnancy and breastfeeding period;
• children's age up to 18 years;
• rare congenital lactose intolerance, lactase deficiency of Lacktase or glucose-galactose macabsorption.

Overdose

Symptoms
Symptoms of overdose depend on the adopted dose of the drug and manifest themselves with signs of oppression of the central nervous system (CNS), ranging from drowsiness to the development of a comatose state. In easy cases, overdose is accompanied by drowsiness, confusion, lethargy; In more severe cases, ataxia, hypotension, methemoglobinemia, respiratory depression and coma appear. Overdose does not threaten life, unless otherwise used other CNS depressants, including alcohol, were not used. Other risk factors, for example, simultaneous disease and weakened patient health, can increase the severity of symptoms and in very rare cases cause death.

Treatment
For an hour after an overdose of the zopylic, it is necessary to rinse the stomach, give activated coal. If necessary, symptomatic and maintenance therapy is recommended in a hospital with respiratory monitoring and cardiovascular activities.
In severe cases, the antagonist of fluumazenyl benzodiazepine receptors can be used as an antidote. It has a short half-life (about an hour). Fluumazenil cannot be used in cases of mixed overdose or as a diagnostic agent.
In the hemodialysis drug overdose is not effective due to the large volume of zoplic distribution.

Precautions

Always, when it is possible, it is necessary to establish the cause of insomnia and the possible provoking factors should be eliminated before appointing a sleeping pyline.

Benzodiazepines and benzodiazepine-like drugs are not appointed as the main means in the treatment of psychosis.

To reduce the risk of developing symptoms when canceling the drug, the treatment of zopiclon must be short-lived or with interruptions.

High risk groups

The greatest caution should be observed in cases if there is alcoholism or addiction from other substances as a history;

Patients with impaired liver function, because Benzodiazepines and benzodiazepine-like drugs with severe liver failure can accelerate the development of encephalopathy, therefore, in this case, they are contraindicated;

Patients with respiratory failure, because Benzodiazepines and their derivatives can coagulate the respiratory center (anxiety and anxiety may be harbing respiratory decompensation);

Elderly patients, because Miorolaxing and sedative action can lead to injuries as a result of falling.

Risk of addiction

Treatment with benzodiazepines and their derivatives, especially long, even in therapeutic doses may result in physical and mental dependence.

The risk of dependence increases with the following factors:

An increase in the duration of treatment (more than 4 weeks);

Alcohol abuse and / or reception of other psychotropic drugs;

Anxiety.

If a physical dependence has been formed in the patient, the sudden cessation of the reception of the zopyl can lead to the development of an abstineent syndrome: headache, muscle pain, anxiety, anxiety, stress, irritability, confusion of consciousness. In more severe cases, symptoms may appear: Derealization, depersonalization, numbness and tingling in the limbs, increased sensitivity to light, noise and touch, hallucination or epileptic seizures.

After the cessation of treatment, the symptoms of the abstinence can manifest themselves within a few days. With the duration of treatment with zopiclon not more than 4 weeks, the likelihood of the development of the symptoms is minimal. Cancel medicinal tool is recommended gradually.

Depression

Benzodiazepines and benzodiazepine-like drugs can not be applied in monotherapy of depression and the treatment of anxiety caused by depression, as they can encourage suicide.

Tolerance

When using benzodiazepines and their derivatives after repeated use, some loss of efficiency is possible for several weeks. In patients who took a zopiklon no more than 4 weeks, cases of addiction were not marked. With the development of tolerance, it is impossible to increase the dose of the drug.

PENOMENUM "DIY"

With the termination of therapy with benzodiazepines and their derivatives in reinforced form, insomnia can be resumed, anxiety, anxiety, mood changes may appear. The appearance of syndrome contributes long-term treatment or sharp cessation of treatment. In this regard, upon completion of treatment, it is recommended to gradually reduce the dose of the drug and inform the patient about it.

Amnesia

Antegrand amnesia, especially when interrupted sleep or after a long period of time between the reception of the tablet and the departure to sleep, can be found. To reduce the risk of antegrade amnesia, a zopiklon should be taken immediately before bedtime and provide conditions for 7-8 hours of continuous sleep.

Psychomotor violations

Like other sedative / sleeping pills, Zopiclon has a depressing effect on the CNS. The risk of development of psychomotor disorders, including disorders of the ability to control vehicles, increases:

If zopiklon is taken within 12 hours before action, requiring the concentration of attention and speed of psychomotor reactions;

When applying zoplics in doses exceeding the recommended;

With the joint use of zopilon with other means that depressing the central nervous system, alcohol or drugs that increase the concentration of zopilon in the blood.

After receiving a zopylon and, in particular, during the first 12 hours after its admission, patients should be refracted from hazardous activities that require the concentration of attention or speed of psychomotor reactions (such as working with mechanisms or management of vehicles).

Somnambulism and related behavior

In patients who accepted Zopiclon and not fully awakened, there were cases of walking in a dream and associated behaviors (for example, cooking and reception, conversations on the phone, car management) with subsequent amnesia. Simultaneous use with zopiclon of medicines, depressing CNS, alcohol consumption, excess of recommended doses increases the risk of developing this violation. Patients who inform about such a disorder of behavior, the drug should be canceled.

Other mental and paradoxical reactions

In the treatment of zopiclon in some patients, mostly elderly, paradoxical reactions were recorded: Increased insomnia, nightmares, anxious, excitement, irritability, aggressiveness, anger attacks, delirium, hallucinations, onyry delirium, confusion, psychotic symptoms, inadequate behavior and others Behavioral disorders. In the event of such reactions, the drug should be canceled.

Risk of cumulation

Benzodiazepines and their analogues are in the body for a time equal to 5 half-life. In patients with disturbed by the liver function and elderly, the half-life of the zopyl can significantly increase. With repeated receptions, the concentration of zoplic and its metabolites in the blood plasma is higher and the saturation stage is achieved later. The efficiency and safety of the drug can be estimated after the saturation stage is achieved. Perhaps the dose correction will be required.

Despite the fact that patients with a violation of the kidney function did not reveal the cumulation of the zopyl with long-term reception, the dose of the drug is reduced by 2 times.

During treatment with zopiclon, alcohol cannot be used, and the reception of drugs containing ethanol should be avoided.

Application during pregnancy and in breastfeeding period

Pregnancy

The experience of using zopilon during pregnancy in humans is limited. Animal research did not reveal a negative impact on the course of pregnancy and the development of the fetus. Nevertheless, the use during pregnancy is not recommended.

Patients should be warned by the attending physician about the need to cancel the use of the drug if they are planning pregnancy or suspects the occurrence of pregnancy.

When prescribing a medicinal product in the third trimester of pregnancy or during childbirth, one should expect the appearance of such symptoms such as hypothermia, hypotension, drowsiness and respiratory depression.

In newborns whose mothers received benzodiazepines or their analogues in the last stages of pregnancy, the appearance of physical dependence and risk of abstinence in the postnatal period is possible.

Period lactation

Zopiclon stands out in maternal milk. Despite the fact that the concentration of zopyl in breast milk is low, during the period of breastfeeding the drug purpose of the drug should be avoided.

Impact on the ability to control vehicles or potentially hazardous mechanisms

Because of its pharmacological properties and the ability to influence the central nervous system, zopiklon can have an adverse effect on the ability to control vehicles or potentially hazardous mechanisms. Risk of psychomotor disorders, including the ability to control vehicles, increases:

• if the zopiklon is accepted within 12 hours before action, requiring the concentration of attention and speed of psychomotor reactions;
• when using a drug in doses exceeding the recommended;
• with the joint use of zopilon with drugs, depressing the central nervous system, alcohol or means that increase the concentration of zopyl blood.

After receiving the zopyclone, especially during the first 12 hours after its admission, patients should be refracted from hazardous activities that require the concentration of attention or speed of psychomotor reactions (such as working with mechanisms or management of vehicles).

Interaction with other medicines

Always tell your doctor, what medicines you take or recently taken, even if these are medicines released without a recipe.

Alcohol

With the simultaneous use of zoplic with alcohol, the sedative effect of benzodiazepines or benzodiazepine-like drugs is enhanced. Cropling can affect the patient's ability to control vehicles or maintain mechanisms. The use of alcoholic beverages and medicines containing ethyl alcohol should be avoided.

Morphine derivatives (Paintal products, means against cough and replacement therapy), Barbiturates - increased the risk of oppression of breathing; In case of overdose, death is possible.

Simultaneous use with medicines that depress the CNS: Morphine derivatives (painkillers, means against cough and replacement therapy), barbiturates, antidepressants and N 1-resistment agents with sedative effects, anti-theft, neuroleptic agents, clonidine and its analogues, talidomide - Strengthening the oppressive action on the CNS. Cropling can affect the patient's ability to control vehicles or maintain mechanisms.

Clozapin

Increased risk of shock with respiratory stop and / or heart activities.

Erythromycin

The effect of erythromycin on the pharmacokinetics of zopilon was studied on 10 healthy individuals.

In the presence of erythromycin AUC zopilon increases by 80%, which indicates an erythromycin's ability to inhibit the metabolism of those drugs that are metabolized under the influence of CYP C4. As a result, the hypnotic action of the zopyl can be intensified.

Since Zopiclon metabolizes the isoenzyme of cytochrome P450 (CYP) in4, when used with CYP inhibitors, for example, erythromycin, clarithromycin, ketoconazole, itraconazole and ritonavir plasma zapplation level may increase. With simultaneous use with CYP inhibitors, it may be necessary to reduce the dose of zopyl.

On the contrary, while using CYP inductors at a CYP, for example, rifampicin, carbamazepine, phenobarbital, phenytio and beast, the plasma zopyl level may decrease. With simultaneous use with CYP inductors, an increase in the dose of zopylic can be necessary.

Storage conditions

In the place protected from moisture and light at a temperature not higher than 25 ºС.

Keep out of the reach of children.

Shelf life

Do not use the expiration date specified on the package.

It is an agonist (stimulator) of central receptors to benzodiazepine. Interact with benzodiazepine CNS receptors (omega 1 and omega 2) macromolecular gamke omega (benzodiazepine chlorionoforous) complex. Benzodiazepine receptors have a non-covalent bond with receptors to GABA. Stimulation of benzodiazepine receptors leads to an increase in the affinity of gamc receptors with a braking neuromediator with gammaamic acid, and an increase in the opening frequency of chlorine channels on the neuron membrane. This process enhances the braking action of the GABC and slows down the transmission of interneurone pulses to the central nervous system.

Activity: ZopiClone

Forms Release: Tablets

Pharmacological impact

Slytopower, cyclopyrrolone derivative. It is an agonist (stimulator) of central receptors to benzodiazepine. Interact with benzodiazepine CNS receptors (omega 1 and omega 2) macromolecular gamke omega (benzodiazepine chlorionoforous) complex. Benzodiazepine receptors have a non-covalent bond with receptors to GABA. Stimulation of benzodiazepine receptors leads to an increase in the affinity of gamc receptors with a braking neuromediator with gammaamic acid, and an increase in the opening frequency of chlorine channels on the neuron membrane. This process enhances the braking action of the GABC and slows down the transmission of interneurone pulses to the central nervous system.

Zopiclon positively affects the duration and quality of sleep, reduces the frequency of night and early awakens, shortens the first phase of sleep and extends the second, and deep stage. Sleep after receiving the drug comes quickly, the rapid sleep phase is not shortening, and the remaining phases are physiologically. In contrast to benzodiazepines and barbiturates, awakening after zopylic is not accompanied by a breakdown and drowsiness.

Pharmacokinetics

Quickly absorbed into the gastrointestinal tract. After 1.5-2 hours, the maximum level in the blood plasma is achieved, which is proportional to the dose of the adopted drug, and varies from 30 to 60 ng / ml. About 45% of the drug is conjugated with plasma proteins. It has good bioavailability - about 80%. After receipt of the blood, pretty quickly leaves the vascular bed. The dose of the drug does not affect its clearance. Within 5 hours, half of the drug is eliminated from the body. With liver failure, half-life increases to 11 hours.

Good permeability through histohematic barriers allows zopiclon to be distributed over all organs, including the CNS.

Easily overcomes the hematoplazent barrier, penetrates into breast milk (pharmacological concentration in milk is twice as much as in the blood plasma). When continuing to breast feeding during the treatment with zopiclon, the child receives about 0.2% of the dose adopted during the day.

Metabolism processes passes in the liver, as a result two inactive metabolites are formed, and low-effective N-oxide. Extracted by the kidneys. About 16% of metabolites are derived with feces, 80% with urine, a slight amount of zoplic is derived by salivary glands. It is not capable of cumulating if the dose of the drug does not exceed the therapeutic, and the duration of reception is less than 14 days.

Effectively stops, caused by stressful situations, psycho-emotional loads, changing time zones, daily or night mode. Sleep duration is up to 8 hours, fast sleep, within a maximum of 30 minutes. In combination with theophylline, it is capable of reduced the frequency of night, and pre-attractive bouts of bronchial asthma, or reduce their duration and severity.

Sleep disorders of various genes are indications for the use of the drug:

• situational insomnia - provoked by stress or neuropsychic overvoltage;
• chronic or short insomnia;
• sleep disorders caused by mental disorders;
• problems with the process of falling asleep;
• night and early awakening;
• postcontusion syndrome.

Contraindications

Hypersensitivity or intolerance of cyclopyrrolone derivatives, respiratory failure above the first degree, Pickwick syndrome, night apnea, hepatocellular insufficiency, myasthenia, pregnancy, lactation period, age up to 18 years.

When taking the drug is pregnant, in the third trimester, nervous violation of the newborn, as well as the manifestation of the cancellation syndrome has.

When applying the zopilon according to the testimony, immediately before childbirth, the following monitoring of a newborn condition is needed.

Due to the penetration of the zopylic in Mother's milk, breastfeeding at the time of reception of the drug should be discontinued, if it is impossible to cancel the therapy with zopiclon.

Side effects substance zopiklon

In the recommended doses, the drug is usually well tolerated, and has a small amount of violations after awakening. Most often, after receiving a zopylic, there may be a bitter or the taste of metal in the mouth, nausea, vomiting, dyspepsia, change in sexual entry. Possible skin rashes.

From the CNS.
Pathological drowsiness, asthenia, fast fatigue, cefalgia, dizziness, increased irritability, violation of consciousness (confusion), walking in a dream, depressive condition, myasthenia, possibly manifestations of ataxia, bone in the eyes, memory deterioration, reducing attention. We rarely meet paradoxical reactions in the form of insomnia, nightmares, manifestations of aggression, attacks of anger, excitation, hallucinatory manifestations.

Perhaps the manifestation of anterograd amnesia, the risk of which is directly proportional to the dose of the drug.

Cases of allergic manifestations in the form of anaphylaxia, urticaria, angioedema edema are recorded.

The hepatic enzymes, transaminase levels, alkaline phosphatase, are very rarely rising,

With systemic reception, addiction, physical and mental dependence, the abstineent syndrome, ricochetic insomnia (return symptoms of sleep disorders after the abolition of the drug) is possible.

Interaction with other drugs

When combining zopils with drugs depressing the central nervous system, (sedative and sleeping agents, antipsychotic drugs, anti-epileptic drugs, some anti-allergic drugs, ethanol) there is an additive effect of effect.

The level of trimipramine in the plasma, after receiving the zopyl decreases, it should not be ignored when they are simultaneously intended. Strengthens the action of Miorolaksanta.

With joint admission with narcotic analgesics or barbituric acid derivatives, the risk of external respiratory oppression increases.

Preparations that inhibit cytochrome p 450 often enhance the action of the zopylic. The level of zoplic in the blood plasma increases, while simultaneously appointed with macrolides, imidazole derivatives, ritonavir antiviral drug. In this case, it is necessary to reduce the dose of the drug to obtain the desired therapeutic effect.

The level of zoplic in the blood plasma is reduced when co-use with rifampicin, phenythion, phenobarbital, preparations containing holly wort to the grass. In such cases, to obtain a therapeutic action, the dose is recommended to increase.

Overdose

When the dose of the drug is exceeded, the following manifestations are possible:

• disorders of the CNS activities from pathological drowsiness to coma;
• violation of movements (ataxia);
• arterial hypotension;
• depression of external breathing;
• lethargy;
• it is possible to death.

Overdose treatment: If after receiving the zopyclone passed no more than an hour, and the patient is conscious, it is recommended to cause vomiting or rinse the stomach; Mandatory is the reception of enterosorbents; In the occurrence of respiratory failure and other symptoms of overdose, treatment is carried out under the conditions of the intensive care unit.

The specific antidote of the zoplic is the benzodiazipine receptor fluumazenyl receptor. Its use is recommended only in stationary conditions, as there is a risk of convulsive seizures, especially in patients whose history is burdened by the presence of convulsive seizures of any genesis or epilepsy suffering. Due to the rapid distribution of zopilon in the tissues of the body, hemodialysis is inexpedient with overdose.

Instructions for applying zoplic

Drug is intended for internal use. The following precautions must be observed and take into account the features of the substance of the substance zopiclon.

• The presence of glucose in the drug zopiklon makes it impossible to use it with congenital galactosemia, glucose and lactose syndrome, and in lactase insufficiency.
• When using cyclopyrrolone derivatives in patients with myasthenia, strict control of neurological status should be carried out due to the possible aggravation of muscle weakness.
• The long-term reception of the zopyl, exceeding 4 weeks, can provoke the development of tolerance (decrease in the therapeutic effect).

The use of cyclopyrrolone derivatives for a long time, threatens the development of drug addiction. In the development of dependence, the following factors are played with an important role:

• treatment for more than 4 weeks;
• excess daily recommended dose;
• anamnesis, burdened with medicinal or alcohol dependence;
• alarm states.

In rare cases, cases of development of dependence without exceeding the therapeutic dose were recorded, and without provoking factors. Due to the interruption of treatment with zopiklon provoked by the presence of addiction, manifests by an abstineent syndrome.

One of the rare manifestations of cancellation syndrome, can be ricochetic insomnia (Reabond insomnia)

When developing changes in psyche, violations of the CNS, aggressive behavior, it is recommended to stop the reception of the drug. Excess dose of the drug, or receiving it with alcohol, increases the risk of walking in a dream.

Cyclicirrolone derivatives are output from the body for 25 days. In people of an elderly age group, and in patients with hepatocellular failure, this period increases significantly. In such cases, an individual dose adjustment is carried out.

Caution is prescribed to the patient an elderly age group, since the sedative or mioryexing effect can provoke injury to the patient.

Treatment with zopiclon should be stopped gradually. The process of reducing the dose may cause concern, irritation, Malgia in patients.

Therapy with zopiclon patients with pathology of external respiratory function is recommended to be carried out in conditions, with the possibility of providing intensive therapy, and continuous monitoring for the functioning of the respiratory system. The sick elderly age group and patients with nephropathy manifestations are recommended to prescribe half the dose of the drug to achieve the therapeutic effect.

Zopiclon is produced in the form of tablets. Each tablet is covered with a shell and contains 7.5 mg of the main active substance - zopiclon and excipients:

• Lactose monohydrate;
• Calcium dihydrogen phosphate;
• Magnesium and stearic acid salts;
• Methylhydroxypropyl cellulose;
• Titanium dioxide and starch products.

Contour cell packaging has 10 (production of Patus "Lubnyfarm" Ukraine), 20 (Aliud Pharma, Germany), 28 (Sanofi Aventis, France) or 30 ("PHARMTECHNOLOGY", Belarus) zopilon tablets of different shapes, depending on the manufacturer .

Pharmacological effect

Pharmacological effects of the drug - sleeping pills, anxiolytic, sedative, central minelaxing. It has anticonvulsant and amnistic impact. Zopiclon induces GABA-Ergic processes in the brain as a result of interaction with omega-benzodiazepine receptors. This leads to increasing the sensitivity of GABA receptors to the neuromediator. As a result, the patient needs less time to fall asleep, night awakening are reduced to minimal quantity, and the total sleep duration increases.

The structure of sleep does not change, the duration of the fast sleep phase does not reduce. Different from benzodiazepines by the fact that it selects the interaction with the isoform of a gamke-receptor, which has an alpha1 subunit. It is proved that alpha1 subunits mediate a sedative effect and amnesia. The therapeutic effect is based on interaction with GAB-receptors located on the membrane of the CNS neurons. These receptors are connected to a chloride channel into a single macromolecular chain. The increase in the inflow of chlorine ions leads to hyperpolarization of membranes and suppressing the neurons of the central nervous system, which contributes to the anxiolytic and Sonic effect of the "zoplic".

The flooding time due to the reception of the prescribed dose of Zopilon takes approximately 25 minutes, and the duration of the drug is within 7 hours.

Pharmacokinetics

"Zopiclon" is easily absorbed into the gastrointestinal tract, it works short-term (therefore, there is no drowsiness in the morning) and does not own a cumulative effect. Metabolism occurs in the liver. The preparation half-life is 6 hours. Approximately 5% of the drug is excreted in a constant form, 75% - kidneys, and 20% of the feces. Recent studies have shown that a small amount of drug is located in the separated salivary glands.

Reducing doses of the drug is necessary in the disease of the liver and in the treatment of elderly patients.

The drug is capable of penetrating the mother's milk, so during the reception of the "zopylic" you need to cancel breastfeeding.

Indications

The "zopiclon" sleeping bag is used in cases:

• Primary / Secondary sleep disorders: problems at the stage of falling asleep, insomnia at night;
• Premature interruption of sleep, dissatisfaction with the quality of sleep, neurosis at night, isomic disorders;
• Insomnia: transient periodic (episodic), situational (simultaneous) and chronic;
• Psychological diseases and disorders manifested by insomnia: the death of a loved one, depressed states, restless disorders, alcoholism, a panic disorder in an anamnesis;
• The existing bronchial asthma, the attacks of which occur at night - Zopiclon in this case is used in combination with the first use of "Theophylline".

Contraindications

• Severe respiratory disorders (for example, when COPD, bronchial asthma);
• Increased sensitivity to the main or additional components of the drug;
• All trimesters of pregnancy, the drug has teratogenic and toxic effects on the fruit in specific doses or in specific periods of pregnancy;
• Breastfeeding - in view of the ability to enter the drug into breast milk, its use is prohibited for the entire period of lactation;
• Age up to 15 years (according to research 2016);
• Bulbar and spinal asthenia.

Method of application and dose

The drug "Zopiclon" is accepted orally once before bedtime. The usual dose is 7.5 mg (which corresponds to one tablet of the drug). With severe sleep disorders, the absence of contraindications and effects from a conventional dose is assigned 15 mg of "zoplic" once (2 tablets).

At the old age, the dose should be 3.75 mg (half of the entire tablet "zopilon"), which is associated with a violation of the exchange in elderly patients and toxic effects of the medication on the body.

Important!

The optimal dosage of the drug is picking up the doctor. The amount of the drug "Zopiclon", which can provoke side effects solely individually and is depending on the characteristics of the body. To avoid side effects and reduce their probability to a minimum, it is necessary to undergo a preliminary examination and regularly observed at a specialist.

Symptoms overdose

• From the gastrointestinal tract: the feeling of bitterness in the mouth, the taste of the metal, the dryness of the mucous membranes of the oral cavity and dyspeptic disorders;
• From the central nervous system: powerful headache, dizziness and loss of consciousness, loss of memory, the appearance of hallucinations, nightmares in a dream and confusion;
• Skin reactions: rash of different localization.

special instructions

1. In the presence of a patient with concomitant bronchial asthma, when using the means together with the "Theophylline", the number of morning attacks, their duration and intensity are reduced;
2. When using the drug lasting less than 4 months, the risk of pharmaceutical dependence is reduced;
3. Reception of the sleeping pill categorically eliminates the use of alcohol;
4. Driving vehicles and the use of mechanical equipment is not prohibited, but requires care and caution.

The cessation of medication after a long treatment should occur gradually. The dose is reduced in gradually up to the absolute cancellation of the drug. This approach to cancellation is due to the fact that there is a chance of the emergence of recurrence of insomnia, an increase in the level of excitability and psychosomatic reactions, migraines and signs of pharmaceutical dependence.

Medicinal interaction

With the joint use of "zopilon" with mines, it increases the impact of the latter; With a simultaneous purpose with morphine and its derivatives or barbiturates, it is quite likely to make a respiratory function, up to the perfect suppression of the respiratory center, which can lead to a fatal outcome; When admitting with cytochrome P450 inhibitors (ketoconazole, erythromycin, roxitromycin and others), the number of "zopylic" in the blood plasma increases significantly.

Price

The price of a sleeping pill "Zopiclon" depends on the region. The average holds between 500 to 800 rubles per pack.

Analogs

Absolute analogues of "zopilon" are sleeping pills:

• "Sonnat";
• "Somnol";
• "Injured";
• "Relakson".

The main active substance in them is the same zopiclon.

Sonnat is made by the Ukrainian Arterium Corporation. You can only buy this drug by pre-order and its price is within 300 rubles.

The Domnol preparation is produced by the Latvian JSC "Grindeks" and the average price for it in pharmacies of Russia is within 250 rubles.

Sleeping "injured" is made in France (Sanofi). The price of this analogue "zopilon" is about 300 rubles per pack.

The domestic product of the manufacturer of OJSC Veropharm "Relakson" is the most inexpensive of the possible analogues of the drug "Zopiclon". In pharmacies, it can be purchased for 80-150 rubles.

All sleeping pills are released strictly according to the doctor's prescription. Independent treatment with such potent means is unacceptable and can lead to irreversible consequences.