Directory of medicines. Zopiclone: ​​instructions for use, analogues and reviews, prices in Russian pharmacies Zopiclone trade name analogues

Zopiclone: ​​instructions for use and reviews

Latin name: Zopiclone

ATX code: N05CF01

Active substance: zopiclone

Manufacturer: Calyx Chemicals & Pharmaceuticals Pvt. (India)

Updating the description and photo: 27.08.2019

1000 pcs. - polyethylene bottles (1) - cardboard packs.
5 kg - plastic bags (1) - plastic containers.
8 kg - plastic bags (1) - plastic containers.
10 kg - plastic bags (1) - plastic containers.
15 kg - plastic bags (1) - plastic containers.
20 kg - plastic bags (1) - plastic containers.

pharmachologic effect

A hypnotic from the group of cyclopyrrolone derivatives. "Non-benzodiazepine" benzodiazepine receptor agonist. It also has sedative, anxiolytic, central muscle relaxant, anticonvulsant and amnestic properties. Like benzodiazepine derivatives, zopiclone enhances GABAergic processes in the brain by interacting with benzodiazepine receptors, as a result of which the sensitivity of GABA receptors to the mediator increases. However, zopiclone appears to interact with different sites on the benzodiazepine receptor than benzodiazepines.

Zopiclone reduces the time it takes to fall asleep, reduces the number of night awakenings, and increases the total duration of sleep. It has virtually no effect on sleep structure and does not significantly reduce the amount of REM sleep. Consequences upon awakening are absent or mildly expressed. Repeated doses of zopiclone are not accompanied by accumulation.

Pharmacokinetics

Quickly and completely absorbed from the gastrointestinal tract. Cmax is reached in 1-3 hours. It easily passes through histohematic barriers, including the BBB, and spreads throughout organs and tissues, incl. brain. T 1/2 - 5.5-6 hours; does not accumulate.

Indications

Sleep disorders (difficulty falling asleep, frequent awakenings at night, early awakening), transient, situational and chronic insomnia; sleep disturbances in mental disorders, bronchial asthma with nocturnal attacks (in combination with a single daily dose).

Contraindications

Severe respiratory failure, pregnancy, lactation (breastfeeding), childhood and adolescence up to 15 years, increased sensitivity to zopiclone.

Dosage

The average therapeutic dose is 7.5 mg orally at night; in severe cases, the dose can be increased to 15 mg. In elderly patients, as well as in cases of impaired liver function, 3.75 mg is used.

Side effects

From the digestive system: sensation of bitter or metallic taste in the mouth, dry mouth, nausea,.

From the side of the central nervous system: dizziness, headache, drowsiness, confusion, anterograde amnesia, hallucinations, nightmares.

Dermatological reactions: skin rash.

Drug interactions

With simultaneous use, it reduces the concentration of trimipramine and its effect.

Zopiclone enhances the effect of drugs that depress the central nervous system (including ethanol).

Gross formula

Pharmacological group of the substance Zopiclone

Nosological classification (ICD-10)

CAS code

Characteristics of the substance Zopiclone

Non-benzodiazepine hypnotic (cyclopyrrolone derivative).

Pharmacology

It is a benzodiazepine receptor agonist. Interacts with central receptors (omega 1 and omega 2 benzodiazepine receptor subtypes) of the macromolecular GABA-benzodiazepine-chlorionophore complex and does not interact with peripheral benzodiazepine receptors. Increases the sensitivity of GABA receptors to the mediator (GABA), which causes an increase in the frequency of opening channels in the cytoplasmic membrane of neurons for incoming currents of chlorine ions. As a result, the inhibitory effect of GABA is enhanced and interneuronal transmission is inhibited in various parts of the central nervous system.

Rapidly absorbed from the gastrointestinal tract. Cmax is reached after 1-1.5 hours. Binding to blood plasma proteins is about 45%. Easily passes through histohematic barriers, including the BBB, and is distributed throughout organs and tissues, incl. brain. Passes through the placental barrier, penetrates into breast milk (in breast milk contained in 2 times lower concentrations than in blood plasma). Metabolized in the liver to form N-oxide, which has little pharmacological activity, and 2 inactive metabolites. T1/2 - 3.5-6 hours, with severe insufficiency of liver function increases to 11 hours. It is excreted mainly by the kidneys in the form of metabolites (80%), as well as through the intestines (16%). There is evidence of excretion of small amounts by the salivary glands. Repeated doses are not accompanied by accumulation of zopiclone and its metabolites.

Shortens the period of falling asleep, reduces the number of night awakenings, improves sleep quality, and does not change the phase structure of sleep. Effective for situational insomnia associated with psycho-emotional stress, changes in the usual rhythm of life (for example, during hospitalization), desynchronosis, incl. when changing time zones, shift work. Sleep occurs within 20-30 minutes after administration and lasts 6-8 hours.

In patients with nocturnal manifestations of bronchial asthma, in combination with methylxanthine drugs (theophylline), it reduces asthma attacks in the early morning hours, reduces their intensity and duration.

Use of the substance Zopiclone

Sleep disorders (difficulty falling asleep, frequent night and/or early morning awakenings), incl. situational, short-term, chronic insomnia; secondary sleep disorders in mental disorders.

Contraindications

Hypersensitivity, severe respiratory failure, pregnancy (especially the first and third trimester), breastfeeding, age under 18 years.

Restrictions on use

Sleep apnea, myasthenia gravis, severe liver failure.

Use during pregnancy and breastfeeding

Contraindicated during pregnancy (especially in the 1st and 3rd trimester). When zopiclone is used by a woman in the third trimester of pregnancy, the newborn may experience nervous system disorders and withdrawal syndrome. If a woman, as prescribed by a doctor, took zopiclone immediately before the onset of labor and childbirth, constant medical monitoring of the newborn is necessary. Breastfeeding should be stopped during treatment (zopiclone passes into breast milk).

Side effects of Zopiclone

From the nervous system and sensory organs: drowsiness, lethargy, fatigue, headache, dizziness, irritability, confusion (more often in the elderly), depressed mood, muscle weakness, impaired coordination of movements, diplopia, memory impairment, paradoxical reactions (increased insomnia, nightmares, nervousness, agitation, aggressiveness , attacks of anger, hallucinations).

Others: bitter or metallic taste in the mouth, dry mouth, nausea, vomiting, allergic skin reactions, changes in libido, anterograde amnesia.

Possible addiction, drug dependence, withdrawal syndrome, incl. rebound insomnia (see "Precautions").

Interaction

When zopiclone is used together with other drugs that depress the central nervous system (including antipsychotics, other hypnotics, antiepileptic drugs, some antihistamines, alcohol), mutual enhancement of the effects is possible.

Zopiclone reduces plasma concentrations of trimipramine.

Overdose

Symptoms: depression of the central nervous system of varying severity (from drowsiness to loss of consciousness).

Treatment: gastric lavage, taking activated carbon; if necessary, symptomatic therapy. The benzodiazepine receptor antagonist flumazenil is used as a specific antidote (in a hospital setting). Hemodialysis is ineffective.

Routes of administration

Inside.

Precautions for the substance Zopiclone

Due to the possibility of developing drug dependence, long-term use may be prescribed by a doctor in exceptional cases. If insomnia does not disappear within 4 weeks, you should inform your doctor. The likelihood of addiction, physical or psychological dependence increases if the prescribed dosage is violated or the duration of treatment exceeds 4 weeks.

Cancellation should be carried out gradually, because with abrupt cessation of treatment, resumption of insomnia, frequent awakenings, headache and muscle pain, anxiety, agitation, absent-mindedness, and irritability are possible.

Paradoxical reactions are more often observed in elderly patients. If paradoxical reactions occur, zopiclone should be discontinued.

Latin name: Zopiclon
ATX code: N05C F01
Active substance:
Manufacturer: Pharmtechnology (Belarus),
Lubnyfarm (Ukraine)
Release from the pharmacy: on prescription
Storage conditions: at t° up to 25°C
Best before date: 2 years

Zopiclone is a drug in tablets to eliminate insomnia and difficulty falling asleep. Prescribed for:

• Sleep disorders (difficulty falling asleep, frequent or early awakenings)
• Chronic insomnia, as well as due to stress, emotional stress
• Sleep disorders due to mental illness
• Asthma accompanied by nocturnal attacks.

Release form and composition

• 7.5 mg zopiclone
• Auxiliary ingredients: lactose (monohydrate), CMC, aerosil, potato starch, talc, E 572.

Medicines in the form of round tablets in the form of a flat cylinder. They are white or creamy. A dividing strip is applied to the surface, the edges of the tablet are beveled. Packaged in blisters of 10 pieces. In a thick cardboard package - from 1 to 3 blisters, instructions for use.

Medicinal properties

The hypnotic drug Zopiclone, which is part of the group of cyclopyrrolone derivatives and is an agonist of GABA receptors in the human brain that are sensitive to benzodiazepines. The substance has sedative, anxiolytic, and anticonvulsant properties.

By acting on GABA receptors in the brain, it activates GABA-ergic processes, after which the sensitivity of nerve endings to the mediator increases.

The substance shortens the phase of falling asleep, provides continuous and longer sleep, reducing the number of awakenings, and has almost no effect on the stages of REM sleep. It has a gentle effect on the body and causes virtually no difficulties when waking up.

After taking the tablets, the substance is absorbed from the gastrointestinal tract at a high speed and almost completely. Peak concentration in the blood is reached after 1-3 hours. Zopiclone penetrates freely into all organs and tissues, including the brain.

Directions for use and dosage

The treatment regimen and daily dose are determined by the treating specialist. It is recommended to begin therapy with the minimum dosage at which a therapeutic effect is possible.

Zopiclone tablets, according to the instructions for use, should be taken immediately before bed, while already lying in bed.

The drug dosage of 3.75 mg (half a tablet) is intended for elderly patients (65+) and people with risk factors. On average, it is recommended to adhere to the following dosage regimens:

• Patients under 65 years of age: 1 tablet every night. (7.5 mg)
• Patients over 65 years of age: ½ table. (3.75 mg) before bedtime. You can take the whole tablet if doctors allow it
• Patients with kidney disease or chronic pulmonary failure: 3.75 mg once daily
• Patients with functional kidney disorders: 3.75 mg every night.

The duration of the course depends on the patient's indications and response to treatment. If possible, therapy should be as short as possible. The maximum duration is 4 weeks (including the time of drug withdrawal).

• Normalization of sleep during spontaneous insomnia (business trip, travel) – 2-5 days
• Temporary sleep disturbance (for example, due to stress) – 2-3 weeks.

In pediatrics, sleeping pills are not used, since the features of its action have not been studied.

During pregnancy and breastfeeding

The average price is 110 rubles.

Based on the results of animal studies, zopiclone does not have a teratogenic effect on the development of offspring. But since the drug has not been tested on pregnant women, it is extremely undesirable to use it during this period. Zopiclone, like other substances from the related group of benzodiazepines, can cause:

• Decreased motor activity and impaired heart rate in the fetus (after taking large doses in the 2nd and 3rd stages of gestation)
• If a pregnant woman took even small dosages of drugs with a benzodiazepine in the last stage of pregnancy, then the child after birth was diagnosed with hypotension, a disorder of the sucking reflex, followed by poor weight gain. Signs of the presence of the drug in the baby’s body are observed on average 1-3 weeks (depending on the rate of elimination of the substance). After pregnant women used large doses of sleeping pills, newborns experienced breathing problems, dyspnea, high excitability, and tremor.

If there is a need to start treatment with Zoviclone during pregnancy, the pregnant woman should take into account possible consequences and avoid large dosages.

Taking sleeping pills while breastfeeding is highly undesirable.

Side effects and contraindications

The use of the drug Zopiclone may be accompanied by undesirable side effects, which manifest themselves with varying degrees of intensity - depending on the size of the dosage used and the degree of sensitivity of the body. Most common by-effect sleeping pills – bitter aftertaste after taking the pill.

Other negative effects of the drug that affect the mental state are:

• Anterograde amnesia, which may worsen as dosage increases
• Behavioral disorders, possible disturbances of consciousness, somnambulism, irritability, increased aggressiveness and anxiety
• Physical and mental dependence that occurs even with small doses of drugs; after stopping the pills – rebound insomnia syndrome
• State of euphoria, excitement, headaches, tremors, tingling on the skin, speech disorders, muscle spasms, depression
• Confusion, unusual dreams and hallucinations, confusion, drowsiness (most often in elderly patients)
• Sexual desire disorder.

In addition to changes in the psycho-emotional state, sleeping pills can also cause other undesirable reactions of the body:

• CVS: rapid heartbeat
• Skin: rash, itching, increased sweating, acute bullous lesions of the dermis and mucous membranes, Lyell's syndrome, erythema multiforme
• Immune system: urticaria, angioedema, anaphylaxis
• Respiratory system: difficulty breathing, dyspnea
• Gastrointestinal tract: bad breath, difficulty digestion, nausea, dryness oral cavity, vomiting, diarrhea/constipation, loss of appetite (increased or decreased), coating on the tongue
• Metabolism: weight loss
• Locomotor system: feeling of heaviness in the arms and legs, muscle weakness
• Visual organs: double vision, amblyopia
• Manifestations of systemic effects on the body: muscle weakness, asthenia, fever, fatigue, lethargy, severe sweating.

If these or other unspecified side effects of zopiclone occur, you should contact your healthcare professional to determine next steps. It is extremely undesirable to interrupt treatment on your own, since incorrect refusal can provoke withdrawal syndrome (manifested in the form of insomnia, muscle pain, changes in the psyche and behavior, nightmares, tachycardia, headaches, delirium).

Severe forms of the syndrome are accompanied by depersonalization, impaired sensitivity of the limbs, photophobia, intolerance to loud sounds and tactile contacts. Some patients have seizures.

The sedative should not be used if:

• Increased individual sensitivity to any of the contained components
• Respiratory disorders
• Aproe at night
• Myasthenia gravis (muscle weakness due to disturbances in neuromuscular transmission)
• Liver diseases, any form of functional failure (chronic, acute)
• Pregnancy (especially in 2.3 years), lactation
• Under 18 years of age.

Precautionary measures

During the course of Zopiclone you should refrain from dangerous species activities (driving, operating complex mechanisms) that require composure and quick reaction.

Overdose

The use of sleeping pills requires compliance with the recommended dosages, since taking excessive doses of Zopiclone can be fatal.

An overdose after accidentally or intentionally taking a large number of tablets affects primarily the state of the central nervous system, causing the patient to experience conditions ranging from drowsiness to coma.

Severe forms of oversaturation with sleeping pills are manifested by muscle weakness, hypotension, depression of respiratory activity, even death.

Measures to eliminate an overdose are determined not only by the severity of the condition, but also by the time of taking the drug. If about an hour has passed since the poisoning, then the patient needs to rinse the stomach, induce vomiting in order to rid the body of the medicine that has not yet been absorbed, and then give adsorbents to drink.

Severe forms of overdose, which require supportive and symptomatic treatment, are eliminated in a hospital setting. Dialysis is not used, since the active substance is distributed throughout all tissues of the organs. It is possible to prescribe Flumazenil, a drug with the opposite effect. If prescribed, neurological disorders may worsen.

Drug interactions

If, while taking Zopiclone, the patient is forced to use other medications, then the possible interaction during a joint course must be taken into account.

• Alcohol: enhances the sedative effect of hypnotic drugs from the group of benzodiazepines.
• Rifampicin reduces the plasma levels of Zopiclone by activating its metabolism by the liver. If it is necessary to combine these drugs, careful monitoring of the effect of Zopiclone is required.
• It is extremely undesirable to combine a sedative with medications that suppress the functioning of the central nervous system: tranquilizers, other hypnotics, drugs with morphine, barbiturates, antiepileptic drugs, anesthesia drugs, antihistamines, etc. Simultaneous use of drugs with similar properties increases the depression of not only the nervous system, but also negatively affects respiratory activity, which may result in the death of the patient.
• Combining drugs with narcotic painkillers enhances euphoric sensations and thereby increases the risk of addiction and accelerating the formation of addiction.
• The metabolism of zopiclone involves cytochrome CYP3A4, so this must be taken into account when taking with drugs with the same metabolic features.

Analogues

If there is a need to select analogues or substitutes for the sleeping pill Zopiclone, you should consult with your doctor. Possible synonyms for Zopiclone: ​​Somnol, Zolinox, Milovan.

A drug for normalizing sleep, eliminating insomnia, premature awakenings. The hypnotic effect is achieved thanks to active substance zopiclone. Recommended intake – ½-1 table. before bedtime.

Pros:

• Action similar to Zopiclone
• Helps you sleep.

Flaws:

• Side effects.

Compound

Each film-coated tablet contains:

Active substance: zopiclone3.75 mg

Excipients: corn starch, croscarmellose sodium, magnesium stearate, povidone, colloidal anhydrous silicon dioxide, microcrystalline cellulose, lactose monohydrate.

Shell composition: hypromellose, titanium dioxide, macrogol 400.

Pharmacotherapeutic group

Sleeping pills and sedatives.

Benzodiazepine-like drugs.

Code ATX: N05 CF01

Pharmacological properties

Zopiclone is a member of the group of psychotropic drugs - cyclopyrrolones, related benzodiazepine derivatives. Pharmacological effects of zopiclone: ​​hypnotic, sedative, anxiolytic, anticonvulsant, muscle relaxant. Under the influence of zopiclone, the time to fall asleep, the frequency of night and early awakenings decreases, the duration of sleep increases and the quality of sleep and awakening improves.

Indications for use

for the treatment of transient short-term insomnia in adults (including difficulty falling asleep, night and early awakenings). for maintenance treatment of chronic insomnia, using a limited period of time.

During a course of treatment, the lowest effective dose of the drug should always be used.

Directions for use and doses

Inside,without chewing or dissolving, immediately before bedtime.

The dose should be adjusted depending on the patient's age, body weight, general health and type of insomnia.

Adults under 65 years of age: 2 tablets (7.5 mg) once daily.

Patients with impaired liver function or respiratory failure:The recommended dose of the drug is 1 tablet (3.75 mg).

In all cases, the daily dose of ZOPICLONE should not exceed 2 tablets (7.5 mg).

Duration of treatment:

Treatment should be, if possible, short-term, ranging from a few days to 2-4 weeks (maximum), including a period of dose reduction:

Transient insomnia (for example, during travel) - 2 - 5 days; short-term insomnia - 2 - 3 weeks (for example, caused by stress).

How to stop treatment

Before starting to use the drug, patients should be explained that therapy should not be long-term and how to gradually stop it. Gradual cessation of treatment reduces the risk of recurrence of insomnia.

To reduce anxiety caused by possible symptoms of discontinuation of the drug, patients should be warned about the possibility of recurrence of insomnia after stopping treatment.

If you miss another dose of the drug, take it immediately. Do not use double dose insteadmissed. Continue taking the drug as recommended by your doctor.

Side effect

The most common side effect with Zopiclone is a bitter or metallic taste in the mouth.

Frequency of occurrence adverse reactions listed as: very common (≥1/10); often (from ≥1/100 to

From the immune system: very rarely - angioedema, anaphylactic reactions.

Mental disorders: infrequently - nightmares, agitation; rarely - confusion, decreased libido, irritability, aggressiveness, hallucinations; frequency unknown - anxiety, delirium, anger, depressed mood, inappropriate behavior (possibly associated with amnesia) and somnambulism, addiction, withdrawal syndrome.

From the nervous system: often - dysgeusia (bitter taste in the mouth), residual drowsiness; infrequently - dizziness, headache; rarely - antegrade amnesia (the risk increases with increasing dose; in some cases, behavioral disorders can additionally be observed); frequency unknown - ataxia, paresthesia.

On the part of the organ of vision: frequency unknown - diplopia.

From the respiratory system, chest and mediastinum:rarely - shortness of breath, frequency unknown - respiratory depression.

From the gastrointestinal tract: often - dry mouth, infrequently - nausea, vomiting; frequency unknown - dyspepsia.

From the hepatobiliary system: very rarely - mild to moderate increase in the level of transaminases and/or alkaline phosphatase in plasma.

From the skin and subcutaneous tissue:rarely - urticaria orrash, itching.

From the musculoskeletal system and connective tissue:frequency unknown - muscle weakness.

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

Injuries, intoxications, complications of manipulations: rare - falls (mainly in elderly patients).

There are reports that after stopping zopiclone, a withdrawal syndrome develops, the symptoms of which vary and can manifest as rebound insomnia, muscle pain, restlessness, tremors, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, hallucinations , nightmares, panic attacks, muscle cramps, gastrointestinal disorders and irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling in the extremities, increased sensitivity to light and noise, tactile hyperesthesia, hallucinations. In very rare cases, seizures may occur.

If shi worsensl any side effect, whether described in this section or not, should beimmediately consult a doctor.

Contraindications

hypersensitivity to zopiclone or to any of the auxiliary components; myasthenia gravis; severe respiratory failure; sleep apnea syndrome; severe liver failure; pregnancy; breastfeeding period; children under 18 years of age; congenital lactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.

Overdose

Symptoms of overdose depend on the dose of ZOPICLONE taken and are manifested by signs of depression of the central nervous system from drowsiness to the development of a coma. In mild cases, overdose is accompanied by drowsiness, confusion, and lethargy; in more severe cases, ataxia, hypotension, methemoglobinemia, respiratory depression and coma appear. An overdose does not pose a threat to life, except in combination with alcohol and drugs that depress the central nervous system.

The presence of concomitant diseases and the weakened condition of the patient can contribute to the severity of symptoms, which in rare cases can lead to death.

Treatment. Within an hour after an overdose of zopiclone, it is necessary to rinse the stomach and give activated charcoal. If necessary, symptomatic and supportive therapy in a hospital setting with monitoring of respiratory and cardiovascular activity is recommended.

In severe cases, the benzodiazepine receptor antagonist flumazenil can be used as an antidote. It has a short half-life (about an hour). Flumazenil should not be used in cases of mixed overdose or as a diagnostic agent. Hemodialysis in overdose is not effective due to the large volume of distribution of zopiclone.

Mutuallyaction with other drugs

Alcohol

When used simultaneously with alcohol, the sedative effect of benzodiazepines or benzodiazepine-like drugs increases. Inhibited attention may affect the patient's ability to control vehicles or service machinery. Should be avoided alcoholic drinks and preparations containing ethyl alcohol.

Morphine derivatives (painkillers, cough suppressants and replacement therapy), barbiturates

Increased risk of respiratory depression; An overdose can result in death. Concomitant use with drugs that depress the central nervous system - morphine derivatives (painkillers, cough suppressants and replacement therapy), barbiturates, antidepressants and Hi-antihistamines with sedative action, anti-anxiety drugs, antipsychotics, clonidine and its analogues, thalidomide

Strengthening the inhibitory effect on the central nervous system. Inhibited attention may affect the patient's ability to drive or operate machinery. Clozapine

Increased risk of shock with respiratory arrest and/or cardiac arrest. Erythromycin

The effect of erythromycin on the pharmacokinetics of zopiclone was studied in 10 healthy volunteers. In the presence of erythromycin, the AUC of zopiclone increases by 80%, indicating the ability of erythromycin to inhibit the metabolism of drugs that are metabolized by CYP3A4. As a result, the hypnotic effects of zopiclone may be enhanced.

Because zopiclone is metabolized by the cytochrome P450 system, plasma levels of zopiclone may increase when coadministered with CYP3A4 inhibitors such as erythromycin, clarithromycin, ketoconazole, itraconazole and ritonavir. When used concomitantly with CYP3A4 inhibitors, a dose reduction of zopiclone may be necessary.

On the contrary, when used simultaneously with CYP3A4 inducers, such as rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's wort, the plasma level of zopiclone may decrease. When used concomitantly with CYP3A4 inducers, an increase in the dose of zopiclone may be required.

Precautionary measures

Whenever possible, the cause of insomnia should be determined and possible precipitating factors should be eliminated before prescribing a sleeping pill. Benzodiazepines and benzodiazepine-like drugs are not prescribed as the main drugs in the treatment of psychosis.

To reduce the risk of drug withdrawal symptoms, treatment with zopiclone should be short-term or intermittent.

High groupsrisk:

The greatest caution should be exercised in cases where there is a history of alcoholism or addiction/dependence on other substances; patients with impaired liver function, because benzodiazepines and benzodiazepine-like drugs in severe liver failure can accelerate the development of encephalopathy, so in this case they are contraindicated; patients with respiratory failure, because benzodiazepines and their derivatives have a depressing effect on the respiratory center (restlessness and anxiety can be harbingers of respiratory decompensation); elderly patients, because muscle relaxant and sedative effects may lead to injury due to falls.

Risk of addiction

Treatment with benzodiazepines and their derivatives, especially long-term, even in therapeutic doses, can lead to physical and mental dependence.

The risk of addiction increases if the following factors are present:

If the patient has developed a physical dependence, sudden cessation of taking ZOPICLONE may lead to the development of withdrawal symptoms: headache, muscle pain, anxiety, restlessness, tension, irritability, confusion. In more severe cases, symptoms may include derealization, depersonalization, numbness and tingling in the extremities, increased sensitivity to light, noise and touch, hallucinations or epileptic seizures.

After stopping treatment, withdrawal symptoms may appear within a few days. When treatment with ZOPICLONE lasts no more than 4 weeks, the likelihood of developing withdrawal symptoms is minimal. It is recommended to discontinue the drug gradually.

Depression

Benzodiazepines and benzodiazepine-like drugs should not be used in the monotherapy of depression and the treatment of anxiety caused by depression, as they may induce suicide.

Tolerance

When benzodiazepines and their derivatives are used after repeated use over several weeks, some loss of effectiveness may occur. In patients taking zopiclone for no more than 4 weeks, cases of addiction were not observed. If tolerance develops, the dose of the drug cannot be increased.

The phenomenon of "recoil"

When therapy with benzodiazepines and their derivatives is stopped in an intensified form, insomnia may resume, anxiety, restlessness, and mood changes may appear. The appearance of the syndrome is facilitated by long-term treatment or abrupt cessation of treatment. In this regard, upon completion of treatment, it is recommended to reduce the dose of the drug gradually and inform the patient about this.

Amnesia

Rarely, antegrade amnesia may occur, especially when sleep is interrupted or after a long period of time between taking the pill and going to bed. To reduce the risk of antegrade amnesia, you should take ZOPICLONE immediately before bedtime and ensure conditions for 7-8 hours of uninterrupted sleep. Somnambulism and related behavior

Sleepwalking and sleep-related behaviors (eg, preparing and eating food, talking on the phone, driving) followed by amnesia have been reported in patients who have taken zopiclone and are not fully awake. Concomitant use of drugs that depress the central nervous system with zopiclone, alcohol consumption, and exceeding recommended doses increases the risk of developing this disorder. In patients who report such behavior disorder, the drug should be discontinued.

Other mental andparadoxical reactions:

During treatment with zopiclone, paradoxical reactions have been reported in some patients, mostly elderly: increased insomnia, nightmares, anxiety, agitation, irritability, aggressiveness, attacks of anger, delirium, hallucinations, oneiric delirium, confusion, psychotic symptoms, inappropriate behavior and others behavioral disorders. If such reactions occur, ZOPICLONE is discontinued.

Risk of accumulation

Benzodiazepines and their analogues remain in the body for a time equal to 5 half-lives. In patients with impaired liver function and the elderly, T/2 may increase significantly. With repeated doses, the concentration of zopiclone and its metabolites in the blood plasma is higher and the saturation stage is reached later. The effectiveness and safety of the drug can be assessed after reaching the saturation stage. Dose adjustment may be required.

Despite the fact that in patients with impaired renal function no accumulation of zopiclone was detected during long-term use, the dose of the drug is reduced by 2 times.

During treatment with ZOPICLONE, you should not drink alcohol, and you should also avoid taking medications containing ethanol.

Pregnancy and breastfeeding

Available data are insufficient to assess the safety of zopiclone during pregnancy and lactation.

Pregnancy

Human experience with zopiclone during pregnancy is limited. Animal studies have not revealed any negative effects on pregnancy and fetal development. However, results obtained in animals do not always correlate with effects in humans. Therefore, the use of the drug during pregnancy is contraindicated.

If ZOPICLONE is prescribed to women of reproductive age, they should be aware of the need to contact their doctor if they suspect or plan to become pregnant to discontinue the drug.

When prescribing the drug in the third trimester of pregnancy or during childbirth, symptoms such as hypothermia, hypotension, drowsiness and respiratory depression should be expected in the newborn.

Newborns whose mothers took benzodiazepines or their analogues during the latter stages of pregnancy may develop physical dependence and risk developing withdrawal symptoms in the postnatal period.

Lactation

Although the concentration of zopiclone in breast milk is low, the drug should be avoided during breastfeeding.