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Somnol tablets p/o 7.5 mg No. 10x1

Name

Somnol.

Release forms

pills.

INN

Zopiclone.

FTG

Sleeping pill.

Description

Round, white film-coated tablets, convex on one side and concave with a score on the other.

Compound

One tablet contains 7.5 mg of zopiclone. Excipients: calcium hydrogen phosphate, anhydrous; potato starch; sodium starch glycolate, magnesium stearate, silicon dioxide; shell composition: dye 33G28707 Opadry II white (hypromellose (E 464), lactose monohydrate, macrogol 3000, titanium dioxide (E 171), triacetin).

Pharmacotherapeutic group

Psycholeptics. Hypnotic and sedatives. Benzodiazepine-like drugs. ATX code: N05CF01

Pharmacological properties

Pharmacodynamics

Mechanism of action Zopiclone is a benzodiazepine-like hypnotic and belongs to the cyclopyrrolone derivatives. Pharmacological properties of zopiclone include hypnotic, sedative, anti-anxiety, anticonvulsant and muscle relaxant effects. These effects are due to the high affinity and specific agonistic effect on the central receptors of the GABA macromolecular complex (BZ1 and BZ2), which regulate the opening of chloride ion channels. Pharmacodynamic effects It has been established that in humans, zopiclone prolongs the duration of sleep and improves its quality, reduces the number of awakenings at night and early in the morning. This action is combined with characteristic changes in the electroencephalogram. Sleep recording studies have shown that in patients suffering from insomnia, zopiclone shortens the first stage of sleep, lengthens the second stage, does not affect or prolongs the deep stages of sleep (third and fourth), and supports paradoxical sleep.

Pharmacokinetics

Absorption After oral administration at a dose of 7.5 mg, zopiclone is rapidly absorbed. The maximum plasma concentration is reached within 1.5-2 hours and is approximately 30 ng/ml and 60 ng/ml after administration of 3.75 mg and 7.5 mg, respectively. Bioavailability is approximately 80%. Absorption is not affected by the duration of use, repeated doses, or gender of the patient. Distribution The drug is rapidly distributed from the vascular bed. Plasma protein binding is weak (approximately 45%) and unsaturated. The risk of interaction with other drugs at the level of protein binding is very low. The volume of distribution is 91.8-104.6 liters. At recommended doses, the half-life of zopiclone is approximately 5 hours. Benzodiazepines and benzodiazepine-like drugs cross the blood-brain and placental barriers and are also excreted into breast milk. During breastfeeding, the pharmacokinetic properties of zopiclone in milk are the same as in plasma. According to calculations, the intake of zopiclone into the baby's body through breast milk will not exceed 0.2% of the dose taken by the mother within 24 hours. Metabolism Zopiclone is metabolized primarily in the liver. In humans, the main metabolites of zopiclone are zopiclone N-oxide (pharmacologically active in animals) and zopiclone N-desmethyl (pharmacologically inactive in animals). In vitro studies indicate that cytochrome P450 (CYP) 3A4 is the most important isoenzyme involved in the formation of both zopiclone metabolites; CYP 2C8 also takes part in the formation of N-desmethyl zopiclone. The apparent half-life (calculated from urine values) is 4.5 hours and 7.4 hours, respectively. Even when large doses are used in animals, no enzyme induction is observed. Elimination When comparing the low renal clearance of unchanged zopiclone (mean 8.4 ml/min) with its plasma clearance (232 ml/min), it is clear that the clearance of zopiclone is predominantly metabolic. The drug is primarily excreted in the urine (approximately 80%) as free metabolites (N-oxide and N-demethylated derivatives) and in feces (approximately 16%). Special groups of patients Elderly patients In elderly patients, liver metabolism is slightly reduced and the half-life is approximately 7 hours. Various studies have not proven its accumulation in the body after repeated use of zopiclone. Impaired renal activity In renal failure, the accumulation of zopiclone and its metabolites with long-term use of the drug has not been established. Hemodialysis is not used in the treatment of overdose due to the large volume of distribution of zopiclone. Liver impairment: In patients with liver cirrhosis, the plasma clearance of zopiclone is reduced (by approximately 40%) due to a slower demethylation process, so dosage adjustments should be made in these patients.

Indications for use

Short-term treatment of insomnia in adults. Zopiclone is prescribed only in cases where sleep disturbances are severe and limit the patient's activity or cause extreme distress.

Directions for use and dosage regimen

For oral use. The lowest effective dose should be used. The dose should be used once and not repeated overnight. Should always be used immediately before bedtime. Dosage The dose should be selected individually for each patient. Adults under 65 years of age: One tablet (7.5 mg) once daily. This dose of 7.5 mg should not be exceeded. Elderly patients (over 65 years): the recommended dose is 3.75 mg (1/2 tablet) per day, which can be further increased to 7.5 mg (1 tablet) per day (only in exceptional cases). Patients with impaired liver function or respiratory failure: The recommended dose is 1/2 tablet (3.75 mg) per day, which can be further increased to 7.5 mg (1 tablet) per day. Patients with renal impairment: Although the accumulation of zopiclone or its metabolites in the case of renal impairment has not been established, treatment is recommended to begin with 1/2 tablet (3.75 mg) per day. In all cases, the dose should not exceed 7.5 mg per day. Children and adolescents: Zopiclone should not be used in children and adolescents under 18 years of age due to a lack of data on safety and effectiveness. Duration of treatment Treatment should be as short as possible, ranging from several days to 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, after a serious accident); - In some cases, it may be necessary to extend the duration of treatment beyond these recommended periods. Increasing the duration of treatment beyond these periods is possible only after re-evaluating the patient's condition, since with increasing duration of treatment the risk of abuse and development of dependence increases. 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, do not use a double dose to replace the missed dose. Continue taking as recommended by your doctor.

Contraindications

- Hypersensitivity to the active substance or to any of the components of the drug, - severe respiratory failure, - severe liver failure, - sleep apnea syndrome, - myasthenia gravis, - pregnancy and lactation, - children and adolescents under 18 years of age , - rare congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Special instructions and precautions for use

Special precautions for use Particular caution should be exercised if you have a history of alcoholism or other addictions, both drug and non-drug (see section “Interaction with other drugs and other types of interactions”). The cause of insomnia should be determined and possible precipitating factors should be eliminated before prescribing a sleeping pill. Insomnia should be assessed systematically. Insomnia may reveal an underlying physical or psychiatric disorder. Persistence or worsening of insomnia after a short period of treatment necessitates re-evaluation of the clinical diagnosis. Benzodiazepines and their analogues are not intended for use as primary agents in the treatment of psychosis. Patients with impaired respiratory function Since hypnotics have the ability to inhibit the activity of the respiratory center of the brain, caution should be exercised when using zopiclone in patients with impaired respiratory function (see section “Side Effects”). Psychomotor disturbances Like other sedative/hypnotics, zopiclone has a depressant effect on the central nervous system (CNS). The risk of developing psychomotor impairment, including impaired ability to drive, increases: • if zopiclone is taken within 12 hours before performing activities that require concentration and speed of psychomotor reactions; • when using zopiclone in doses exceeding the recommended ones; • when zopiclone is used simultaneously with other drugs that depress the central nervous system, alcohol or drugs that increase the concentration of zopiclone in the blood (see section “Interaction with other drugs and other types of interactions”). Patients should be warned that after taking zopiclone, especially during the first 12 hours after taking it, they should avoid engaging in hazardous activities that require alertness or psychomotor speed (such as operating machinery or driving vehicles). Habituation Repeated use of benzodiazepines and their analogues over several weeks may reduce the effectiveness of their action. When treating with the drug Somnol, significant tolerance was not observed if the duration of treatment was less than 4 weeks. Do not exceed the recommended dose. Dependence Taking zopiclone may lead to the development of a state of physical and mental dependence on the drug and/or abuse. The risk of developing dependence increases with increasing dose and duration of treatment. The risk of abuse and dependence is higher in patients with a history of mental disorders and/or alcoholism, drug addiction and drug abuse. Zopiclone should be administered with extreme caution to patients with, or a history of, alcohol, drug or drug abuse or dependence. Drug dependence can occur when taken in therapeutic doses and/or in patients without individual risk factors. In the case of zopiclone, drug dependence has been reported when the drug is taken at therapeutic doses. If physical dependence develops, suddenly stopping the drug will be accompanied by withdrawal symptoms, which may include the following: headaches, muscle pain, significant agitation, restlessness, anxiety, irritability, impaired consciousness. In severe cases, the following symptoms may appear: derealization, depersonalization, hyperacusis, numbness and tingling in the extremities, increased sensitivity to light, noise and any physical stimulus, hallucinations, convulsions. Withdrawal symptoms may appear for several days after stopping treatment. For short-acting benzodiazepines, and especially if they are prescribed in high doses, withdrawal symptoms may even appear between two doses of the drug. When combining several benzodiazepines, regardless of indication (expected anxiolytic or hypnotic effect), the risk of dependence may increase. Cases of abuse have also been reported. Duration of treatment Information about the duration of treatment should be clearly communicated to the patient depending on the type of insomnia (see section "Method of administration and dosage regimen"). Procedure for gradual discontinuation of treatment Steps to take when discontinuing a drug should be clearly explained to the patient. In addition to the need for gradual cessation of treatment, the patient should be warned about the possibility of withdrawal syndrome to minimize the development of insomnia that may occur due to symptoms associated with cessation of treatment, even in the case of gradual cessation of treatment. The patient should be warned about possible problems associated with stopping treatment. Amnesia It is possible to develop anterograde amnesia, especially when sleep is interrupted or after a significant period of time between taking the drug and going to bed. To reduce the risk of developing anterograde amnesia, you must: • take the pill immediately before going to bed; • ensure sufficient sleep throughout the night (at least 7-8 hours). Risks of Concomitant Use with Opioids Concomitant use of opioids with benzodiazepines or other sedative/hypnotic drugs, including zopiclone, may cause sedation, respiratory depression, and death. Because of these risks, concomitant use of opioids and benzodiazepines should only be used in patients for whom alternative treatment options have failed. If a decision is made to coadminister zopiclone and opioids, use the lowest effective dose for the minimum duration of concomitant use and carefully monitor the patient for signs and symptoms of respiratory depression and sedation (see Drug Interactions and Other Interactions). "). Patients and their caregivers (if any) should be informed of the possibility of these symptoms. Other psychiatric and paradoxical reactions In some patients, the use of benzodiazepines and their analogues can lead to a syndrome that is associated, to varying degrees, with disturbances in the state of consciousness, as well as disturbances in behavior and memory. Paradoxical reactions may appear: - increased insomnia and nightmares; - nervousness, irritability, anxiety, agitation, aggressiveness, attacks of anger; - delirium, hallucinations, oneiric delirium, psychotic symptoms, nightmares, inappropriate behavior and other behavioral disorders. This syndrome may be accompanied by disorders that are potentially dangerous for the patient or other people, for example, behavior that is unusual for the patient; aggressive behavior towards oneself or others, especially if other persons try to interfere with the patient’s activity; automatic driving with retrograde amnesia. The occurrence of these disorders leads to the need to discontinue treatment. Somnambulism and Related Behaviors Patients who took zopiclone and were not fully awakened experienced sleepwalking and other similar behaviors, such as sleep-driving, cooking and eating food, or talking on the phone, followed by amnesia for such behavior. The use of alcohol and other CNS depressants concomitantly with zopiclone increases the risk of this behavior, as does the use of zopiclone in doses exceeding the maximum recommended dose. Due to the risk to the patient and those around him, it is recommended that zopiclone is discontinued in patients with sleepwalking disorders (see sections "Interaction with other medicinal products and other types of interactions" and "Side effects"). Risk of accumulation Benzodiazepines and their analogues remain in the body for more than 5 of their half-lives (see section “Pharmacokinetics”). In elderly patients or patients with hepatic impairment, the half-life may be significantly prolonged. When administered repeatedly, the drug or its metabolites reach equilibrium much later and at much higher levels. Only after reaching equilibrium can both the effectiveness and safety of the drug be assessed. The dose may need to be changed (see section "Method of administration and dosage regimen"). This circumstance was not observed in studies when zopiclone was prescribed to patients with renal failure (see section “Pharmacokinetics”). Suicidal Behavior and Depression Some epidemiological studies have shown increased rates of suicidal ideation, suicide attempts, and suicide in patients with or without depression who took benzodiazepines or other hypnotics, including zopiclone. A cause-and-effect relationship has not been established. The use of the drug Somnol, as well as other drugs with sedative/hypnotic effects, in patients with symptoms of depression requires special caution. Since such patients may be suicidal, they should be given the minimum required number of zopiclone tablets (considered when writing a prescription and dispensing the drug) to avoid the possibility of deliberate overdose by the patient. Manifestation of pre-existing depression is possible while taking the drug Somnol. Because insomnia can be a symptom of depression, if insomnia persists, the patient should be re-evaluated to evaluate for possible depression. Just like other sleeping pills, the drug Somnol does not treat depression and may even mask its symptoms. Benzodiazepines and their analogues should not be used in monotherapy for depression and for the treatment of anxiety caused by it, as this leads to an increased risk of suicide. Elderly Patients Benzodiazepines and their analogues should be prescribed with caution to elderly patients due to the risk of sedation and/or muscle relaxant effects, which may contribute to falls, which often have serious consequences in this population, and due to the higher incidence of behavioral disorders. Elderly patients and patients with impaired renal function No accumulation of zopiclone was detected with repeated use of the drug. However, as a precautionary measure, it is recommended to reduce the single dose to 3.75 mg per day (see sections “Pharmacokinetics” and “Method of administration and dosage regimen”). Pediatric Population Zopiclone should not be used in children and adolescents under 18 years of age as the safety and effectiveness of zopiclone in this age group have not been established. High-risk groups: - the greatest caution should be observed in cases where there is a history of alcoholism or addiction/dependence on other substances; - patients with respiratory failure, since benzodiazepines or their analogues can have a depressing effect on the respiratory center, especially since anxiety and agitation can be symptoms indicating decompensated breathing; - patients with severe liver dysfunction, since benzodiazepines or their analogues can cause encephalopathy, so in these cases they are contraindicated; - patients over 65 years of age. Excipients The coating of Somnol tablets contains lactose, therefore this drug should not be used in patients with rare congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption. Interaction with other drugs and other types of interactions Sedative drugs It should be taken into account that many drugs or substances can enhance the depressive effect on the central nervous system and contribute to a decrease in the level of wakefulness. Decreased levels of wakefulness and impaired attention can make driving and operating machinery dangerous. These drugs include morphine derivatives (analgesics, cough suppressants and replacement therapy), antipsychotics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (for example, meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative antihistamines from the group of H1 receptor blockers, centrally acting antihypertensives, baclofen and thalidomide. Sleeping pills Benzodiazepines and benzodiazepine-like drugs (zolpidem, zopiclone) or antihistamines from the group of H1 receptor blockers are currently prescribed as sleeping pills. In addition to increased sedation when prescribing other central nervous system depressants or when drinking alcohol, benzodiazepines must also be aware of the potential for increased respiratory depressant effects, especially with morphine derivatives, other benzodiazepines or phenobarbital, especially in elderly patients. Opioids Concomitant use of benzodiazepine derivatives and other hypnotic drugs, including zopiclone, and opioids increases the risk of sedation, respiratory depression, coma, and death due to additive depressant effects on the central nervous system. In these cases, it is necessary to reduce the dose, as well as the duration of simultaneous use of benzodiazepines and opioids (see section "Special instructions and precautions for use"). Interactions that are not recommended Ethanol (in the form of drinks or in other drugs) Ethanol increases the sedative effect of benzodiazepines and benzodiazepine-like drugs. Impaired attention can make driving and operating machinery dangerous. It is necessary to stop drinking alcoholic beverages and medicines containing ethanol. Sodium oxybate (sodium hydroxybutyrate) Increased depressant effects on the central nervous system. Decreased levels of wakefulness can make driving and operating machinery dangerous. Combinations for which precautions should be taken Rifampicin Decreased plasma concentrations and decreased effects of zopiclone due to increased hepatic metabolism. Clinical observation is required. It may be necessary to discontinue zopiclone and prescribe another hypnotic drug. Combinations to consider Barbiturates Increased risk of respiratory depression, which can be fatal in case of overdose. Other hypnotics Increased depressant effect on the central nervous system. Other sedative drugs Increased depressant effect on the central nervous system. Impaired attention can make driving and operating machinery dangerous. Buprenorphine When coadministered with buprenorphine, there is an increased risk of respiratory depression, which can be fatal. A careful assessment of the benefit/risk ratio of this combination is necessary. The patient should be informed of the need to comply with the prescribed dose. Clozapine Increased risk of shock with respiratory arrest and/or cardiac arrest. CYP3A4 inhibitors, such as erythromycin, clarithromycin, ketoconazole, itraconazole and ritonavir Since zopiclone is metabolized by CYP3A4, CYP3A4 inhibitors may increase plasma concentrations of zopiclone. As a result, the hypnotic effects of zopiclone may be enhanced. If administered concomitantly, a dose reduction of zopiclone may be necessary. CYP3A4 inducers When used concomitantly with CYP3A4 inducers, for example, carbamazepine, phenobarbital, phenytoin and St. John's wort, plasma concentrations of zopiclone may decrease. When taking zopiclone, the patient should consult a doctor before taking any other medications.

Fertility, pregnancy and breastfeeding

Pregnancy There are no sufficient data on use during pregnancy. A large body of evidence from cohort studies has shown no evidence of malformations due to exposure to benzodiazepines in the first trimester of pregnancy. However, some epidemiological case-control studies have observed an increased incidence of cleft lip and palate with benzodiazepine use. Cases of decreased fetal movement and fetal heart rate variability have been reported following the use of benzodiazepines in the second and/or third trimesters of pregnancy. The administration of zopiclone at the end of pregnancy or during labor has been associated with hypothermia, hypotension, feeding difficulties (which can lead to low birth weight of the newborn), and respiratory depression in newborns. Moreover, infants born to mothers who took long-term sedative/hypnotic drugs during late pregnancy may develop physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period. Appropriate monitoring of these newborns in the postnatal period is recommended. Zopiclone should not be prescribed to women during pregnancy. If zopiclone is prescribed to a woman of childbearing potential, she should be advised to consult a physician if she is pregnant or planning to become pregnant to determine further treatment. Breastfeeding Although the concentration of zopiclone in breast milk is very low, zopiclone should not be prescribed to breastfeeding women.

Impact on the ability to drive vehicles and operate machinery

Zopiclone significantly affects the ability to drive vehicles and operate machinery, as it causes sedation, decreased ability to concentrate, blurred vision and impaired muscle function. The risk of psychomotor impairment, including impaired ability to drive, increases if: - zopiclone is used 12 hours before activities that require alertness; - a higher dose than recommended was used or - zopiclone was used together with other CNS depressants, alcohol and other drugs that increase the level of zopiclone in the blood. The patient should be warned about the need to avoid activities that require full attention or coordination of movements, such as servicing machinery or driving vehicles, especially within 12 hours after using the drug. Patients should be warned not to consume alcohol or other psychoactive substances while taking zopiclone. The risk of impaired attention increases if the patient's sleep duration was insufficient.

Side effect

The listed adverse reactions are indicated according to the classification of organ system groups and MedDRA frequency: very often (≥1/10), often (≥1/100 to

Overdose

Symptoms As in all cases of overdose, the possibility of simultaneous poisoning with multiple drugs should always be considered; this may worsen the prognosis of poisoning. Overdose is usually expressed as central nervous system (CNS) depression, ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, confusion, and lethargy; in severe cases there may be ataxia, hypotension, hypotension, respiratory depression and coma. Overdose is usually not life-threatening unless other CNS depressants, including alcohol, were used concomitantly. Other risk factors, such as pre-existing medical conditions and the patient's frailty, may increase the severity of symptoms and lead to death. Treatment In case of overdose, symptomatic and supportive treatment should be carried out, the following measures are necessary: placement in a specialized department, monitoring of respiratory and cardiovascular indicators and, if necessary, infusion of appropriate fluids. If the overdose occurred no more than an hour ago, vomiting should be induced (if the patient is conscious); in another case, the stomach should be rinsed and the airway should be kept open. If an overdose occurs earlier, the absorption of the drug can be reduced with the help of activated carbon. In severe cases with severe central nervous system depression, the benzodiazepine receptor antagonist flumazenil can be used. It has a short half-life (about an hour). Flumazenil should not be used in concomitant overdose with other drugs or as a diagnostic test. In case of drug overdose, hemodialysis is not important due to the large volume of distribution of zopiclone.

Storage conditions

Store in a place protected from moisture and light at a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life: 3 years. Do not use after the expiration date stated on the package.

Vacation conditions

On prescription.

Package

10 tablets in a blister made of polyvinyl chloride film with a polyvinylidene chloride coating and aluminum foil. 1, 2 or 3 blisters along with instructions for medical use in a cardboard pack.

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Instructions for use for Somnol tablets p/o 7.5 mg No. 10x1

Side effects

- From the digestive system: very often - bitter or metallic taste in the mouth; possibly - digestive disorders (dyspepsia, nausea, dry mouth), a slight increase in the activity of transaminases and/or alkaline phosphatase in the blood serum. - From the nervous system: possible upon awakening - drowsiness, dizziness, headache, depression, aggressiveness, anterograde amnesia, euphoria and impaired coordination of movements. Psychiatric and paradoxical reactions - nightmares, confusion, hallucinations and behavioral changes, for example, irritability, confusion, depressed mood, inappropriate behavior, which may be associated with amnesia, somnambulism (sleepwalking), impaired libido (these side effects are more often observed in elderly people, but they are rarely severe). — Allergic reactions: skin itching, rash, anaphylactic reactions and/or angioedema. - When stopping therapy: rebound insomnia may occur (frequent awakenings, resumption of insomnia or its intensification) or the emergence of drug dependence, but this usually happens after long-term use; very rarely - convulsions.

Contraindications

- severe respiratory failure; - severe pseudoparalytic myasthenia gravis (myasthenia gravis); - severe acute and chronic liver failure; — sleep apnea syndrome; - lactation period (breastfeeding); — age up to 18 years; - congenital galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption; - hypersensitivity to the components of the drug. With caution: the drug should be prescribed to patients with a history of alcohol, drug or drug addiction; concomitantly taking alcohol or other psychotropic drugs (increased risk of dependence or abuse).

Mode of application

For adults:

The drug is taken orally, immediately before going to bed at night. Somnol® should be used, if possible, short-term, no longer than 4 weeks, including the period of dose reduction. Increasing the duration of treatment beyond the maximum permissible period is carried out after re-evaluating the patient's condition. Treatment should always be started at the lowest effective dose and never exceed the maximum dose. Adults under the age of 65 are prescribed 7.5 mg (1 tablet) 1 time / day. In patients with impaired renal function, treatment is recommended to begin with a dose of 3.75 mg (1/2 tablet) 1 time / day, although accumulation of zopiclone or its metabolites in case of renal failure has not been observed. For patients with impaired liver function, treatment begins with a dose of 3.75 mg 1 time/day, since drug elimination in this category of patients is reduced. If necessary, the dose can be carefully increased to 7.5 mg 1 time / day, taking into account the patient's sensitivity to the drug. Patients with respiratory failure are prescribed 3.75 mg 1 time / day. In elderly patients over 65 years of age, treatment begins with a dose of 3.75 mg 1 time / day. If necessary, the dose can be gradually increased, taking into account the individual sensitivity of the patient. In all cases, the daily dose of the drug should not exceed 7.5 mg. Duration of treatment Transient insomnia: from 2 to 5 days. Situational insomnia: 2 to 3 weeks. Chronic insomnia: the duration of course treatment is determined after consultation with a specialist.

pharmachologic effect

Sleeping pill, cyclopyrrolone derivative. It has hypnotic, sedative, tranquilizing, anticonvulsant and muscle relaxant effects. This spectrum of action is associated with the influence of zopiclone on CNS receptors related to the macromolecular GABA complex and modulation of the opening of channels for chloride ions. Zopiclone has the ability to reduce the time of falling asleep and the frequency of night and early awakenings, increases the duration of sleep, and improves the quality of sleep and awakening. These effects are combined with a characteristic electroencephalographic profile that differs from that recorded with benzodiazepines. For insomnia, zopiclone reduces phase I, prolongs phase II sleep and maintains or prolongs stages of deep sleep (III and V) and paradoxical (rapid eye movement) sleep. Sleep occurs within 30 minutes and lasts 6-8 hours. Use of zopiclone for 4 weeks does not cause significant rebound insomnia, nor does the hypnotic effect escape (when taken for up to 17 weeks). Absorption After oral administration, zopiclone is rapidly and completely absorbed from the gastrointestinal tract. Cmax in blood plasma is reached within 1.5-2 hours and is approximately 30 ng/ml and 60 ng/ml after oral administration of the drug in doses of 3.75 mg and 7.5 mg, respectively. Absorption of zopiclone is independent of gender and does not depend on food intake. Distribution The degree of binding to plasma proteins is weak (approximately 45%) and unsaturated. The risk of interaction with other drugs at the level of protein binding is very low. Zopiclone is rapidly distributed from the systemic circulation. Vd is 91.8-10.4 l. Zopiclone easily crosses the BBB. Concentrations of zopiclone in breast milk are similar to those in plasma. The intake of zopiclone into the child’s body through breast milk does not exceed 1% of the dose taken by the mother within 24 hours. After repeated use, the accumulation of zopiclone and its metabolites does not occur. Interindividual differences are insignificant. Metabolism and excretion The main metabolites are the N-oxide derivative (pharmacologically active) and the N-demethyl metabolite (pharmacologically inactive). T1/2 is approximately 4.5 and 7.4 hours, respectively. At recommended doses, T1/2 of unchanged zopiclone is approximately 5 hours. The low renal clearance of unchanged zopiclone (8.4 ml/min) compared to its plasma clearance (232 ml/min) indicates that zopiclone clearance is predominantly metabolic.

Zopiclone is excreted in the urine (approximately 80%), mainly in the form of metabolites; approximately 16% is excreted in the feces. Pharmacokinetics in special clinical situations In elderly patients: despite a slight decrease in liver metabolism and an extension of T1/2 to approximately 7 hours, no accumulation of zopiclone in plasma was detected even with repeated use. In patients with renal failure: no accumulation of zopiclone or its metabolites was detected even after long-term use. In patients with liver cirrhosis: due to a decrease in the demethylation process, the plasma clearance of zopiclone is reduced by approximately 40%, so dose adjustment is necessary

Interactions of the drug Sonmil

Increases the depressant effect on the central nervous system of barbiturates, benzodiazepines, clonidine, opioid analgesics, neuroleptics, ethanol. Antidepressants (with the exception of selective MAO inhibitors), centrally acting antitussives, tranquilizers can significantly enhance the sedative effect of doxylamine. When used simultaneously with atropine and atropine-like drugs, imipramine, antiparkinsonian drugs with anticholinergic action, disopyramide, phenothiazine neuroleptics, antispasmodics, the risk of developing anticholinergic side effects (dry mouth, urinary retention, constipation) increases.

Release form

The tablets are white, film-coated, round, convex on one side, concave with a score on the other.

1 tab. zopiclone 7.5 mg. Excipients: anhydrous calcium hydrogen phosphate - 152.3 mg, dried potato starch - 4.25 mg, magnesium stearate - 1.7 mg, sodium carboxymethyl starch - 1.7 mg, silicon dioxide - 2.55 mg.

Shell composition: dye 33G28707 Opadry white (hypromellose - 40%, lactose monohydrate - 24%, macrogol 3000 - 22%, titanium dioxide - 8%, triacetin - 2.6%) - 2.6 mg.

10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cellular contour packages (3) — cardboard packs.

Source

Pharmacological properties of the drug Sonmil

Pharmacodynamics. Sleeping pill, sedative, antihistamine, antiallergic drug. Blocker of histamine H1 receptors of the ethanolamine group with a pronounced sedative and M-anticholinergic effect. Penetrates the central nervous system and has a sedative and hypnotic effect. Makes it easier to fall asleep, increases the duration and improves the quality of sleep, does not change the physiological phases of sleep. Pharmacokinetics. After oral administration, it is well absorbed from the gastrointestinal tract. Penetrates through histohematic barriers (including the BBB) and is distributed in tissues and organs. Passes into breast milk in small quantities. Metabolized in the liver. Excreted by the kidneys (60% unchanged) and partially through the intestines. May pass into breast milk.