Sonovan - instructions, composition, dosage, side effects of use

Pharmacodynamics and pharmacokinetics

The drug belongs to the cyclopyrrolones . This is a sleeping pill. It acts as a specific receptor agonist. This medicine prolongs sleep, reduces the frequency of night awakenings, and improves sleep quality.

The drug is quickly absorbed. Time of administration, gender and number of doses do not affect absorption. The maximum concentration is reached after 90-120 minutes. Bioavailability – 80%.

The drug is quickly distributed from the vascular bed. The degree of binding to plasma proteins is approximately 45%.

The decrease in plasma concentration in the dosage range of 3.75–15 mg does not depend on the dose. The half-life is about 5 hours.

Imovan is metabolized in the liver to form metabolites : N-oxide and N-demethylated derivative . It is excreted mainly in the form of metabolites. Approximately 80% - with the kidneys, approximately 16% - with feces.

Side effects

Adverse reactions are individual in nature, they depend on the dosage and personal sensitivity of the person to the components of the drug. The most common side effect is a bitter taste in the mouth. In addition, the following reactions may occur:

• Cardiovascular system: sensation of heartbeat.
• Systemic effects: muscle hypotension, chills, sweating , asthenia , fatigue.
• Visual organs: diplopia , amblyopia .
• Gastrointestinal tract: coated tongue, dyspepsia , dry mouth, diarrhea , anorexia , bad breath, nausea, vomiting, constipation , increased appetite.
• Metabolism: weight loss.
• Skin: skin rash, sweating, toxic epidermal necrolysis , itching , Stevens-Johnson syndrome , erythema multiforme . If these symptoms occur, the drug should be stopped.
• Immune system: urticaria , anaphylactic reactions, angioedema .
• Respiratory system: dyspnea , shortness of breath .
• Musculoskeletal system: heaviness in the limbs, muscle weakness.

Laboratory tests may also rarely show an increase in transaminases and/or alkaline phosphatase levels.

In rare cases, seizures .

Elderly patients may experience rapid heartbeat, anorexia , restlessness, tremor , vomiting, sialorrhea , and a feeling of restlessness.

Clinical studies have documented cases of anger and behavioral disturbances that are caused by amnesia .

After discontinuation of the drug rebound insomnia , anxiety, increased sweating, confusion, palpitations, delirium , irritability, muscle pain, tremor , agitation , headache , tachycardia , and nightmares are possible. derealization , hyperacusis , increased sensitivity, depersonalization , numbness or tingling sensation in the extremities, and hallucinations may occur .

Sonovan instructions for use

The drug Sonovan is a hypnotic, sedative drug. Zopiclone belongs to the cyclopyrrolones group and is related to the pharmaceutical class of benzodiazepines. The pharmacodynamic effects of zopiclone are qualitatively similar to those of other compounds of this class: muscle relaxant, anxiolytic, sedative and hypnotic agent, anticonvulsant, amnestic (memory impairment). These effects are due to the fact that it acts as a specific agonist of receptors belonging to the macromolecular GABA-omega receptor complex in the central nervous system (which are called BZ1 and BZ2 and modulate the opening of chloride ion channels). In humans, zopiclone has been found to prolong sleep duration, improve sleep quality, and reduce the frequency of nighttime and early awakenings. This effect is due to characteristic electroencephalographic characteristics that differ from those characteristic of the action of benzodiazepines. Polysomnographic studies show that Zopiclone reduces the duration of stage I and increases the duration of stage II sleep, maintains or prolongs stages of deep sleep (III and IV) and maintains the stage of paradoxical or rapid eye movement (REM) sleep. Pharmacokinetics. Absorption. Zopiclone is rapidly absorbed: peak plasma concentrations are reached after 1.5-2 hours and are 30, 60 and 115 ng/ml after administration of 3.75 mg, 7.5 mg and 15 mg, respectively. Bioavailability is about 80%. Absorption is not affected by the time of administration, repeated doses and gender of the patient. Distribution. Zopiclone is very quickly distributed from the vascular bed. Plasma protein binding is low (about 45%); unsaturated binding. The risk of drug interactions due to substitution at the protein binding site is very low. The decrease in plasma concentrations in the dose range from 3.75 mg to 15 mg does not depend on the dose. The half-life is approximately 5:00. Benzodiazepines and related compounds cross the blood-brain barrier and placenta and are excreted into breast milk. During breastfeeding, the pharmacokinetic profiles of zopiclone in maternal milk and plasma are similar. The estimated percentage of dose consumed by the infant does not exceed 0.2% of the dose received by the mother in 24 hours. Metabolism. Zopiclone is extensively metabolized in the liver. The two main metabolites are the N-oxide (pharmacologically active in animals) and the N-demethylated derivative (pharmacologically inactive in animals). Their apparent half-lives, determined in urinary excretion studies, are approximately 4.5 and 7.5 hours, respectively. This is consistent with the fact that after repeated doses (15 mg) for 14 days there is no significant accumulation. During the studies, there was no increase in enzymatic activity in animals, even when administered in high doses. Conclusion. The low renal clearance of unchanged zopiclone (mean 8.4 ml/min) compared with plasma clearance (232 ml/min) suggests that zopiclone is excreted primarily as metabolites. Approximately 80% of the substance is excreted by the kidneys in the form of free metabolites (N-oxide and N-demethylated derivative), and about 16% in feces. Composition: 1 Sonovan tablet contains 7.5 mg of zopiclone. Excipients: microcrystalline cellulose, lactose, corn starch, calcium phosphate, croscarmellose sodium, magnesium stearate. Film shell: hypromellose, titanium dioxide (E 171), polyethylene glycol, polysorbate 80, sunset yellow FCF (E 110), brilliant blue FCF (E 133).

Indications for use: Sonovan is recommended to be taken for severe sleep disorders: situational and temporary insomnia.

Directions for use: For oral use. Treatment with Sonovan should always begin with the minimum effective dose and the maximum dose should not be exceeded. The drug should be taken in bed just before bedtime! The 3.75 mg dose is intended specifically for older people over 65 years of age and those at particular risk. Usual doses: adults under 65 years of age: 7.5 mg per day; patients over 65 years of age: 3.75 mg per day; the 7.5 mg dose can only be used in exceptional cases; patients with impaired liver function or chronic pulmonary failure, the recommended dose is 3.75 mg per day (see section “Pharmacokinetics”); patients with renal failure, treatment should begin with a dose of 3.75 mg per day (see section “Pharmacokinetics”). In all cases, the daily dose of Sonovan should not exceed 7.5 mg. Duration of treatment. Treatment should be as short-term as possible. The duration of the course of treatment should not exceed 4 weeks, including the period of gradual cessation of treatment (see Section “Peculiarities of application”). Patients should be advised to take the drug: in case of situational insomnia - 2-5 days (for example, while traveling) in case of temporary insomnia - 2-3 weeks (for example, caused by a serious event). Sometimes it may be necessary to increase the recommended treatment period. In such a situation, the patient's condition should be carefully re-evaluated.

Side effects: Side effects when using the drug Sonovan depend on the dose and individual sensitivity of the patient. The most commonly observed side effect is a bitter taste in the mouth. Side neurological and mental effects (see Section "Peculiarities of use"): anterograde amnesia, which can occur when using therapeutic doses (the risk increases in proportion to the dose); behavioral disorders, altered consciousness, irritability, delirium, aggressiveness, restless behavior, somnambulism (see section “Peculiarities of use”); physical and psychological dependence, even when using therapeutic doses, with withdrawal symptoms or rebound insomnia after cessation of treatment (see section “Peculiarities of use”); feeling of intoxication, headache, euphoria, tremor, paresthesia, speech disorders, muscle spasms, dizziness, lack of coordination, depressive moods, in exceptional cases - ataxia; confusion, hallucinations, decreased attention or even drowsiness (especially in elderly patients), insomnia, nightmares, agitation, tension; changes in sexual desire. From the cardiovascular system: palpitations. Skin: skin rash, itching, which may be symptoms of hypersensitivity, sweating, Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome, erythema multiforme. It is necessary to stop using the drug if symptoms occur. Systemic effects: muscle hypotension, asthenia, chills, increased fatigue, sweating. From the immune system: urticaria, angioedema, anaphylactic reactions. From the organ of vision: diplopia, amblyopia. From the respiratory system: shortness of breath, shortness of breath. From the gastrointestinal tract: gastrointestinal disorders: coated tongue, bad breath, dyspepsia, nausea, dry mouth, vomiting, diarrhea, constipation, anorexia or increased appetite. Abnormal laboratory test results: very rarely - increased transaminases and/or alkaline phosphatase levels, which can sometimes lead to a clinical picture of liver dysfunction. Metabolism: decrease in body weight. From the musculoskeletal system: heaviness in the limbs, muscle weakness. Elderly patients are more likely to experience palpitations, vomiting, anorexia, sialorrhea, agitation, restlessness, and tremor. Post-marketing studies: anger, behavioral disturbances associated with amnesia. Withdrawal syndrome has been reported when treatment with Sonovan is discontinued (see section "Peculiarities of Application"). Withdrawal symptoms vary and include rebound insomnia, muscle pain, anxiety, tremors, excessive sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, and irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling in the extremities, increased sensitivity to light, noise and physical contact, hallucinations. Very rarely, seizures may occur.

Contraindications: Sonovan is contraindicated for use in patients with: hypersensitivity to zopiclone or to any of the excipients of the drug; respiratory failure; sleep apnea syndrome; severe, acute or chronic liver failure (due to the risk of encephalopathy) myasthenia gravis; allergies to wheat products (except wheat intolerance for celiac disease); congenital galactosemia; glucose or galactose malabsorption syndrome or lactase deficiency (due to lactose content in the drug).

Pregnancy: Animal studies have shown that zopiclone is not teratogenic. Clinical data on the effect of this drug on the body of the mother and fetus during pregnancy is not yet sufficient. By analogy with related products (benzodiazepines): a decrease in motor activity and changes in fetal heart rate may be observed when taking high doses of zopiclone during the second and/or third trimester of pregnancy; When benzodiazepines were used at the end of pregnancy, even in low doses, newborns showed signs of absorption, such as axial hypotonia and impaired sucking, and, as a result, insufficient weight gain. These signs are reversible but may persist for 1 to 3 weeks, depending on the half-life of the intended benzodiazepine. At high doses, neonates may experience reversible respiratory depression or apnea and hypothermia. In addition, newborns may develop withdrawal symptoms, even in the absence of signs of absorption. It is characterized, in particular, by such symptoms in newborns as excessive excitability, psychomotor agitation and tremor, observed some time after birth. The timing of their appearance depends on the half-life of the drug and may increase the half-life. Given these data, during pregnancy, regardless of trimester, the use of zopiclone is not recommended. If there is a need to start treatment with zopiclone during pregnancy, it is necessary to avoid prescribing high doses and remember the above-mentioned effects when monitoring the newborn. Breastfeeding period. Zopiclone is not recommended for use during breastfeeding.

Interaction with other drugs: Undesirable combinations. Alcohol potentiates the sedative effect of benzodiazepines and related substances. As a result of reduced concentration, driving a vehicle and operating machinery can be dangerous. Patients should avoid drinking alcoholic beverages or taking medications that contain alcohol. Combinations requiring action. Rifampicin. A decrease in plasma concentrations and a decrease in the effectiveness of zopiclone due to increased metabolism in the liver, therefore the simultaneous use of zopiclone and rifampicin requires careful clinical monitoring. If necessary, another sleeping pill may be prescribed. Combinations that should be taken into account. Other drugs that suppress the activity of the central nervous system: morphine derivatives (analgesics, antitussives and drugs for substitution therapy in the treatment of drug addiction, except buprenorphine), antipsychotics, barbiturates, anxiolytics, other hypnotics, sedative antidepressants, antiepileptic drugs, anesthetics, sedatives H1-antihistamines, centrally acting antihypertensives, baclofen, thalidomide, pizotifen. Increased inhibition of central nervous system activity. As a result of reduced concentration, driving a vehicle and operating machinery can be dangerous. In addition, the simultaneous use of zopiclone with morphine derivatives (analgesics, antitussives and drugs for substitution therapy in the treatment of drug addiction) and barbiturates increases the risk of respiratory depression, which in case of overdose can be fatal. Narcotic analgesics increase euphoria, which can lead to increased psychological dependence. Zopiclone is metabolized by the cytochrome P450 (CYP) 3A4 isoenzyme, so when administered concomitantly with CYP3A4 inhibitors, plasma levels of zopiclone may increase, and when administered concomitantly with CYP3A4 inducers, plasma levels of zopiclone may decrease. Buprenorphine. When buprenorphine is used as replacement therapy for drug addiction, there is an increased risk of respiratory depression, which can potentially be fatal. The risk/benefit of this combination must be carefully weighed. Patients should be warned about the need to strictly adhere to the doses prescribed by the doctor. Clozapine. Increased risk of developing collapse with respiratory arrest and/or cardiac arrest. Clarithromycin, erythromycin, telithromycin. Slight increase in the sedative effects of zopiclone. Ketoconazole, itraconazole, voriconazole. Slight increase in the sedative effects of zopiclone. Nelfinavir, ritonavir. Slight increase in the sedative effects of zopiclone.

Overdose: Overdose with Sonovan can be life-threatening, especially in cases of simultaneous overdose of several central nervous system depressants (including alcohol). When taking a large amount of zopiclone, an overdose manifests itself mainly in depression of the central nervous system, which leads to a state ranging from drowsiness to coma, depending on the dose received. Mild overdose results in symptoms of confusion or lethargy. In more serious cases, ataxia, muscle hypotonia, arterial hypotension, methemoglobinemia, respiratory depression, and sometimes death were observed. Other risk factors that may worsen overdose symptoms are concomitant medical conditions. Treatment. If an oral overdose occurred earlier than 1:00 ago, the patient can be induced to vomit; in other cases, gastric lavage should be performed. Following this, administration of activated charcoal may be helpful to reduce drug absorption. Close monitoring of cardiac and respiratory function in a specialized department is recommended. When treating overdose, hemodialysis is not appropriate because Zopiclone has a large volume of distribution. For the diagnosis and/or treatment of accidental or intentional overdose of benzodiazepines, the administration of flumazenil may be useful. Flumazenil has the opposite effect of benzodiazepines, and therefore can cause neurological disorders (excitement, anxiety, convulsions and emotional lability), especially in patients with epilepsy.

Storage conditions: Store in a dry place, protected from light and out of reach of children, at a temperature not exceeding 30 ° C.

Release form: Sonovan - film-coated tablets. Packaging: 10 tablets in a blister, 1 or 2 blisters in a cardboard box.

Additionally: Disclaimers. This medicine contains lactose and is therefore not recommended for use in patients with rare hereditary diseases such as galactose intolerance, Sami lactase deficiency or glucose-galactose malabsorption syndrome. This medicine can be prescribed to patients with celiac disease. Wheat starch may contain gluten, but only in trace amounts, and is therefore considered safe for these patients. Getting used to the drug. When benzodiazepines or related substances are used for several weeks, their sedative and hypnotic effects may gradually decrease, although the dose remains the same. In patients whose treatment period with Sonovan did not exceed 4 weeks, no pronounced addiction to the drug was observed. Drug dependence. Treatment with benzodiazepines and related substances, especially long-term, can lead to physical and psychological pharmacological effects. Several factors contribute to the development of addiction: duration of treatment, dose, history of dependence on medications or other substances, including alcohol, and anxiety. Dependence may develop when using therapeutic doses and/or in patients without specific risk factors. In exceptional cases, dependence on zopiclone has been observed at therapeutic doses. Once treatment is stopped, addiction may lead to withdrawal symptoms. Some of these symptoms occur frequently: insomnia, headache, excessive anxiety, myalgia, muscle tension and irritability. Other symptoms occur less frequently: restlessness or even confusion, paresthesia of the limbs, increased sensitivity to light, noise and physical contact, depersonalization, derealization, hallucinations and seizures. Withdrawal symptoms also include tremors, palpitations, tachycardia, delirium, nightmares, irritability, hyperacusis, numbness and tingling in the extremities. Withdrawal symptoms may develop several days after stopping treatment. When using short-acting benzodiazepines, especially at high doses, withdrawal symptoms may occur even between two doses. The risk of drug dependence may increase when multiple benzodiazepines are used simultaneously to treat anxiety or sleep disorders. There are also isolated cases of drug abuse. Rebound insomnia. This transient rebound effect may manifest itself as an exacerbation of insomnia for which treatment with benzodiazepines or related drugs was originally prescribed. Amnesia and impaired psychomotor function. Anterograde amnesia and impaired psychomotor function may occur within a few hours after taking the tablet. To reduce the risk of their development, the patient should take the tablet immediately before bedtime, that is, already in bed (see Section “Dosage and Administration”) and make sure that the conditions are as favorable as possible for several hours of uninterrupted sleep (7-8 hours). Behavioral disorders. In some patients, benzodiazepines and related substances can cause a syndrome of altered consciousness (of varying degrees) with impaired memory and behavior. The following symptoms may develop: exacerbation of insomnia, nightmares, agitation, nervousness; delusions, hallucinations, oneiric state, confusion, psychosis-like symptoms; mental retardation, mild excitability; euphoria, irritability; anterograde amnesia; suggestibility (suggestibility). These symptoms may be accompanied by disorders that are potentially harmful to the patient or others: abnormal behavior; self-aggression or aggression towards other persons, especially if family members or friends try to prevent the patient from doing what he wants; automatic behavior followed by amnesia. The appearance of these symptoms requires cessation of treatment. Psychotic behavior changes most often occur in patients with aggressive behavior and unusual reactions to sedatives, benzodiazepines, and alcohol use and also include depersonalization, anxiety, and anger. The drug affects cognitive functions, namely mental activity and concentration. The risk of these complications is more pronounced in patients with cerebral disorders. Some patients may feel restless and anxious during the day. Somnambulism and related behavior. In patients receiving treatment with zopiclone, episodes of complex behavior were observed (when the patient took a sleeping pill-sedative and did not fully wake up), such as driving in his sleep, preparing and eating food, making telephone calls - the actions of which he did not remember. Although behavioral disturbances associated with somnambulism may occur with zopiclone monotherapy at therapeutic doses, concomitant use of alcohol and other central nervous system depressants increases the risk of such behavior, as does the use of zopiclone in doses exceeding the maximum recommended dose. Patients who have developed disorders associated with somnambulism are advised to stop taking zopiclone; this may be dangerous for the patients themselves and their environment (see section “Interaction with other drugs and other types of interactions” and section “Adverse reactions”). Risk of drug accumulation. Benzodiazepines and related substances (like any other drug) remain in the body for a time equal to approximately 5 half-lives (see Section "Pharmacokinetics"). In elderly patients and patients with impaired liver function, the half-life may be significantly longer. After repeated dosing, zopiclone or its metabolites reach steady state much later and at higher levels. The effectiveness and safety of the drug can only be assessed if a steady state is achieved. Dose adjustment may be necessary (see Section "Dosage and Administration"). During clinical studies in patients with renal failure, no accumulation of zopiclone was observed (see section "Pharmacokinetics"). Elderly patients. Caution should be exercised when treating elderly patients with benzodiazepines or related drugs due to the increased risk of behavioral disorders and the risk of developing sedative and/or muscle relaxant effects, which can cause falls, which often have serious consequences for this category of patients. Precautions for use. Particular caution is recommended when prescribing to patients with a history of alcoholism or other types of dependence on drugs or other substances (see Section “Interaction with other drugs and other types of interactions”). Before prescribing a sleeping pill in all cases of insomnia, a comprehensive assessment and elimination of the root causes of its occurrence is required. Insomnia can be a sign of a physical or mental disorder. If, after a short period of treatment, insomnia persists or worsens, the clinical diagnosis should be reevaluated. Duration of treatment. The duration of treatment for the patient should be determined strictly according to the indications, depending on the type of insomnia he has (see Section “Method of administration and dosage”). Depression is a major depressive episode. Since insomnia can be a symptom of depression, depression needs to be treated. If insomnia persists, the clinical diagnosis should be reevaluated. In patients with a major depressive episode, benzodiazepines and related drugs should not be prescribed as monotherapy because they do not treat the depression and the depression will continue to develop, with an unchanged or increased risk of suicide. Because these patients may be at risk for suicide, the smallest number of zopiclone tablets should be available to them to minimize the risk of intentional overdose. Gradual dose reduction. Patients should be clearly explained how to gradually stop the treatment process. In addition to the need for gradual dosage reduction, patients should also be warned about the risk of rebound insomnia to minimize the development of any insomnia that may arise from symptoms caused by discontinuation of treatment, even gradual. Patients should be informed of the possible discomfort during the tapering period. Respiratory failure. When prescribing benzodiazepines and related drugs to patients with respiratory failure, one should be aware of their depressant effect on the respiratory center (especially because anxiety and restlessness can be warning signs of respiratory decompensation, which requires transfer of the patient to the intensive care unit). Elderly patients with renal failure. Although no accumulation of zopiclone has been observed after long-term use, it is recommended that this group of patients be given half the usual recommended dose as a precaution (see Dosage and Administration and Precautions). Caution should be exercised when prescribing to patients with depression. It is not recommended for use in patients with severe liver failure and encephalopathy. It is not recommended to prescribe the drug at the initial stage of treatment of psychosis. The ability to influence the reaction rate when driving vehicles or other mechanisms. You should refrain from driving vehicles and working with other mechanisms. Patients who drive vehicles and operate machinery should be warned about the risk of drowsiness. The combined use of zopiclone with other sedatives is not recommended and should be taken into account when driving or operating machinery (see Section “Interaction with other medicinal products and other types of interactions”). The risk of poor attention is further increased if sleep duration is insufficient. The use of Sonovan in children has not been studied, so it is not recommended for this group of patients.

Instructions for use of Imovan (Method and dosage)

The course of use of the drug should be short-term if possible. The instructions for Imovan recommend taking it immediately before bed. Treatment for situational insomnia lasts 2-5 days, for temporary insomnia – 2-3 weeks. For chronic insomnia, the duration of the course is determined individually.

Instructions for use of Imovan indicate the following dosages:

• patients under 65 years of age – 7.5 mg per day;
• for patients over 65 years of age - an initial dosage of 3.75 mg per day, which is increased if necessary.

In case of problems with liver function and respiratory failure, the dosage is 3.75 mg per day.

Sonovan - instructions, composition, dosage, side effects of use

Sonovan

Sonovan _

international and chemical name : zopiclone, 4-methyl-1-piperazinecarboxylic acid 6-(5-chloro-2-pyridyl)-6, 7-dihydro-7-hydroxy-5H-pyrolo-[3, 4-b]pyrazine ester -5-one;

Main physical and chemical characteristics : blue, oval, wallpaper-convex tablets, film-coated, with a dividing notch and printing 7. 5 and Z on one side and the P logo on the other side;

Compound. 1 tablet contains 7.5 mg of zopiclone;

other ingredients: microcrystalline cellulose, anhydrous lactose, pregelatinized starch, calcium phosphate, croscarmellose sodium, magnesium stearate, Opadry blue dye.

Release form of the medicine. Film-coated tablets.

Pharmacotherapeutic group. Sleeping pills. ATS N05C F01.

Action of the medicine . Pharmacodynamics.

Sonovan is a fast-acting hypnotic drug that belongs to a new chemical class of psychotropic drugs - a derivative of cyclopyrrolone. In terms of the chemical structure, Sonovan differs from modern sleeping pills, but its pharmacological action is close to benzodiazepines. The hypnotic effect of the drug is due to the specific ability to bind to benzodiazepine receptors in the brain, which leads to inhibition of the functional activity of CNS cells. The drug does not bind to peripheral benzodiazepine receptors and weakly binds to serotonin, GABA receptors, a1, a2 adrenergic receptors and dopamine receptors. The drug shortens the period of falling asleep, increases the duration of sleep, and reduces the number of night awakenings. After taking the drug, sleep quickly occurs, which is characterized by a normal phase structure and duration; the hour of the REM sleep phase does not decrease. The absence of aftereffects after waking up ensures normal working ability during the daytime.

Pharmacokinetics.

Sonovan is quickly and well absorbed. Bioavailability of the drug is 75%. After taking a single dose (7.5 mg), the peak concentration of the drug in the blood plasma - 60 ng/ml - is achieved in less than 2 hours. Repeated doses of 7.5 mg for 14 days do not lead to the accumulation of the drug or its metabolites. The half-life averages 5 hours (range 3.8 to 6.5 hours). The level of binding to plasma proteins is low (@ 45% at plasma concentrations of 25 - 100 ng/ml). From 4 to 5% of the drug is found unchanged in the urine. The main metabolites are N-oxide derivative (» 12%), which has low pharmacological activity, and the inactive N-desmethyl metabolite (» 16%) are excreted through the kidneys. More than 90% of the taken dose of the drug is completely eliminated from the body within 5 days: 75% in the urine, 16% in the feces.

Capsicum fruits: instructions for use and description of the medicine.

In elderly patients, the bioavailability of the drug is increased to 94%, the half-life is increased (about 7 hours), and accumulation of the drug as a result of repeated doses is not observed.

In patients with impaired liver function, the half-life is significantly increased (11.9 hours), the hour of peak plasma concentration increases to 3.5 hours.

In patients with mild to moderate renal failure, the pharmacokinetics of the drug are unchanged.

Sonovan has the ability to pass into breast milk, where its concentration is 50% of the dose of the drug taken by the mother.

Indications for use . Short-term symptomatic treatment of insomnia, which is characterized by difficulty falling asleep, frequent nighttime and/or early awakenings.

Method of use and dose.

Sonovan should be taken only as directed by a doctor. The drug is taken orally before bedtime.

Adult patients are prescribed 1 tablet (7.5 mg) at night. The usual course of treatment is 7–10 days of continuous use. Treatment can be continued for up to 2–3 weeks, which requires careful medical examination and drug monitoring.

For elderly patients and/or patients with weakened mental abilities, the initial dose should be 3.75 mg. Depending on the effectiveness and tolerability of the drug, the dose may be increased to 7.5 mg.

Patients with impaired liver function or chronic respiratory failure: the recommended dose is 3.75 mg. If necessary, in some cases the dose can be increased to 7.5 mg.

Side effect. In recommended doses, the drug is well tolerated and, with short-term treatment, does not affect memory, respiratory and other body functions, and, as a rule, does not cause addiction, mental and physical dependence, or withdrawal syndrome. In some cases, the following adverse reactions may occur:

Central nervous system: drowsiness, weakness, dizziness, confusion, anterograde amnesia or memory impairment, euphoria, nightmares, lack of coordination, depressed mood, nervousness, tendency to aggressive behavior, decreased libido, hypotension, tremor, muscle spasms, paresthesia, speech disorders. Severe dizziness and/or loss of coordination of movements indicates intolerance to the drug or its overdose.

Moreal plus description and instructions for use of the drug.

Cardiovascular system: increased heart rate.

Digestive system: dryness and bitter taste in the mouth, tongue congestion, vomiting, dyspepsia, constipation, weakened or increased appetite.

Respiratory system: shortness of breath.

Skin reactions: redness, spots on the skin, sweating. Redness of the skin may be a sign of hypersensitivity to medications, in which case you should stop taking them.

Metabolism and nutrition: weight loss.

Others: headache, feeling of heaviness in the legs, chills, blurred vision.

In elderly patients, more often than in young patients, with increasing doses, adverse reactions may occur in the form of increased heart rate, vomiting, anorexia, confusion, agitation, anxiety, tremor, sweating.

Restrictions and contraindications in the use of the drug. Sonovan is contraindicated in patients with hypersensitivity to the drug or its components, as well as in persons with serious respiratory dysfunction, sleep apnea syndrome. Sonovan is also contraindicated in patients who have had a history of paradoxical reactions to alcohol or sedatives. The drug should not be prescribed to patients under 18 years of age, as well as during pregnancy and breastfeeding.

Exceeding the permissible dose of the drug (overdose) . Signs of a drug overdose (when taking up to 370 mg) may be prolonged sleep, nausea, blurred consciousness, coma with suppression or absence of reflex activity.

Treatment is symptomatic. In case of acute overdose, immediate gastric lavage, intravenous fluid administration and artificial respiration are recommended.

Flumazenil is a specific antidote used to treat overdose of benzodiazepines and benzodiazepine-like drugs.

Features of use. Sleep disturbances may be a sign of physical and/or mental changes in the body, which require a comprehensive examination of patients before prescribing sleeping pills.

In this regard, the drug should be prescribed with caution to patients with impaired liver or kidney function, as well as severe pulmonary insufficiency.

When using the drug for myasthenia gravis, it is necessary to ensure neurological control due to a possible increase in muscle weakness.

Feresol - instructions, composition, dosage, side effects of use

Sonovan is not recommended for use in patients with signs of depression, as it may worsen its symptoms. If treatment is required, such patients are prescribed a minimum dose.

Caution must be exercised when prescribing the drug to patients with behavioral abnormalities and unusual reactions to alcohol, benzodiazepines and benzodiazepine-like drugs.

Elderly patients should be prescribed the lowest possible dose and be warned about the sedative effect of the drug, which can lead to falls and injuries.

Sonovan should not be taken simultaneously with alcohol and other drugs that suppress the activity of the central nervous system.

Patients who use the drug should refrain from potentially unsafe activities that require increased attention, working with devices, and driving vehicles.

You should not take the drug when it is impossible to ensure adequate sleep in order to avoid daytime drowsiness.

Insomnia that remains after 7-10 days of treatment indicates the presence of a primary mental or physical illness and requires discontinuation of the drug, a comprehensive examination of the patient and the appointment of appropriate treatment.

With long-term treatment with high doses of the drug and a sharp suspension of its use, as well as in some cases, more often in older people, withdrawal syndrome may develop (convulsions, tremors, abdominal and abdominal pain, nausea, sweating, impaired perception and insomnia) .

Therefore, patients who take the drug for more than 2 weeks without a break should gradually reduce the dose until it is completely discontinued.

The risk of developing drug dependence is greater in individuals who suffer from alcohol or drug dependence on other drugs.

Do not exceed the prescribed dose.

If there are any changes in behavior, thinking, or the appearance of unusual symptoms, you should consult a doctor.

Interaction with other drugs. Sonovan enhances the suppressive effect of alcohol on the central nervous system, the sedative effect of antihistamines, anticonvulsants and psychotropic drugs. Drugs that inhibit certain liver enzymes (cimetidine, erythromycin) may increase the effect of Sonovan.

Features of conditions, shelf life and sales. . Keep in a dry place, protected from light, out of reach of children, at a temperature of 15-30 ° C.

Shelf life – 5 years.

Overdose

Use of the drug in high doses can be life-threatening, especially when multiple CNS depressants (including alcohol) are used simultaneously.

The main manifestation of an overdose is depression of the central nervous system, which causes drowsiness or even coma . If the dose is slightly exceeded, confusion or lethargy may occur. High dosages can lead to ataxia , hypotension , respiratory depression, muscle hypotension , methemoglobinemia , and sometimes death.

If 60 minutes have not passed after the overdose, the patient can be induced to vomit; in other cases, gastric lavage is performed. In addition, it will be useful to take activated carbon in order to reduce the degree of absorption of the drug.

It is advisable to monitor the functioning of the cardiac and respiratory systems. of Flumazenil may help .

Hemodialysis is not advisable, since the active substance of the drug is characterized by a large volume of distribution.

Instructions for use SONNAT

addictive

After using benzodiazepines or their derivatives for several weeks, the sedative or hypnotic effect of the same dose may gradually decrease. In patients whose treatment period with zopiclone did not exceed 4 weeks, there was no significant addiction to the drug.

Addiction

Treatment with benzodiazepines and their derivatives, especially long-term, can lead to physical and psychological pharmacodependence. Several factors contribute to the development of addiction:

• duration of treatment, dose, history of dependence on drugs or other substances (including ethanol), anxiety. In very rare cases, dependence on zopiclone has been observed when using the drug in therapeutic doses.

After treatment ends, addiction can lead to withdrawal symptoms. Some withdrawal symptoms occur frequently but are mild: insomnia, headache, anxiety, myalgia, muscle tension and irritability. Other symptoms occur very rarely:

• agitation or even confusion, paresthesia of the limbs, increased sensitivity to light, noise and physical contact, depersonalization, derealization, hallucinations and seizures. Withdrawal syndrome may develop several days after stopping treatment. When using short-acting benzodiazepines, especially at high doses, withdrawal symptoms may occur between two doses. The risk of dependence may increase when multiple benzodiazepines (anxiolytics or hypnotics) are used simultaneously. There are also isolated cases of drug abuse.

Rebound insomnia

As an exacerbation of insomnia, which was tried to be treated with benzodiazepines or their derivatives, transient rebound insomnia may develop.

Amnesia and changes in psychomotor functions

For several hours after taking the drug, anterograde amnesia and changes in psychomotor functions may occur. To reduce the risk of their development, you should take the drug immediately before bed, making sure that the conditions are as favorable as possible for several hours of uninterrupted sleep.

Behavioral disorders

In some patients, benzodiazepines and their derivatives can cause varying degrees of changes in consciousness and disturbances in memory and behavior: exacerbation of insomnia, nightmares, agitation, nervousness, delusions, hallucinations, oneiric state, confusion, psychosis-like symptoms, euphoria, irritability, anterograde amnesia , suggestibility (suggestibility). These symptoms may be accompanied by disorders that are potentially harmful to the patient or others:

• abnormal behavior, self-aggression or aggression towards others (especially if family members or friends try to prevent the patient from doing what he wants), automatic behavior with subsequent amnesia. The appearance of these symptoms requires cessation of treatment.

Somnambulism and related behavior

Patients who took zopiclone and did not fully wake up experienced somnambulism and other types of similar behavior when the patient, while sleeping, drives a car, prepares and eats food, makes phone calls, and has sexual intercourse, after which he does not remember anything. The use of alcohol and other CNS depressants with zopiclone increases the risk of behavioral disorders that occur when zopiclone is used in doses that exceed the maximum recommended dose. If such behavioral disturbances develop, it is strongly recommended that you stop taking zopiclone.

Risk of drug accumulation

Benzodiazepines and their derivatives, as well as other drugs, remain in the body for a certain time, which is approximately five T1/2. In elderly patients and patients with impaired liver function, T1/2 can be significantly increased. After repeated use, zopiclone or its metabolites reach equilibrium much later and at higher concentrations. The effectiveness and safety of the drug can only be assessed when steady state is achieved.

During clinical studies in patients with renal failure, accumulation of zopiclone was not observed.

Elderly patients

When prescribing benzodiazepines or their derivatives to elderly patients, one should be aware of their sedative and/or muscle relaxant effects, which can cause falls, which often have serious consequences in this group of patients.

Precautions for use

It is recommended to exercise special caution when prescribing the drug to patients who have a history of alcoholism or other types of dependence on drugs or other substances.

Insomnia can be a sign of a physical or mental disorder. If insomnia persists or worsens after a short period of treatment, the clinical diagnosis should be re-evaluated.

Duration of treatment

The duration of treatment should be set clearly and according to indications, depending on the type of insomnia the patient has.

Patients with major depressive episode

Benzodiazepines or their derivatives should not be prescribed as monotherapy, since in this case depression continues to develop and is accompanied by an unchanged or increased risk of suicide.

Gradual cessation of treatment

Patients should be clearly explained how to stop the treatment process, and also warned about the need for a gradual dose reduction and the risk of rebound insomnia. This will minimize insomnia that may occur due to withdrawal symptoms caused by stopping treatment, even gradually. Patients should be informed of the potential for discomfort during the taper period.

Patients with respiratory failure

When prescribing benzodiazepine and its derivatives to patients with respiratory failure, one should be aware of the inhibitory effect of these drugs on the respiratory center (since anxiety and restlessness may be warning signs of respiratory decompensation, which requires transfer of the patient to the intensive care unit).

Patients with renal failure and elderly patients

Although no accumulation of zopiclone has been observed after long-term use, it is recommended that this group of patients be given half the usual recommended dose as a precaution. Patients should be cautioned not to take the drug concomitantly with other sedatives.

Use in pediatrics

Zopiclone is not prescribed to children.

Impact on the ability to drive vehicles and operate machinery

While using zopiclone, you should refrain from driving vehicles or operating other machinery.

Interaction

You should not take drugs in combination with Imovan that have a depressant effect on the nervous system, namely: morphine , sedatives, antipsychotics, barbiturates, tranquilizers, clonidine , etc.

Taking concomitantly with Clozapine increases the likelihood of respiratory and cardiac arrest. In addition, during the course of treatment you should not drink alcohol or alcohol-containing products.

The combination of Imovan and Erythromycin causes an uncontrolled increase in the effect of zopiclone.

Sonnovan®

Pharmacokinetic interaction

— Melatonin is known to induce the CYP3A isoenzyme in vitro at concentrations significantly higher than therapeutic concentrations. The clinical significance of this phenomenon is not fully understood. If signs of induction develop, consider reducing the dose of concomitantly used drugs.

— At concentrations significantly higher than therapeutic levels, melatonin does not induce CYP1A isoenzymes in vitro. Therefore, the interaction of melatonin with other drugs due to the effect of melatonin on CYP1A isoenzymes is apparently insignificant.

- Melatonin metabolism is mainly mediated by CYP1A isoenzymes. Therefore, it is possible that melatonin may interact with other drugs due to the effect of melatonin on isoenzymes of the CYP1A group.

- Caution should be exercised in patients taking fluvoxamine, which increases the concentration of melatonin (increase in AUC by 17 times and Cmax by 12 times) due to inhibition of its metabolism by cytochrome P450 isoenzymes (CYP): CYP1A2 and CYP2C19. This combination should be avoided.

- Caution should be exercised in patients taking 5- and 8-methoxypsoralen, which increases melatonin concentrations due to inhibition of its metabolism.

- Caution should be exercised in patients taking cimetidine (an inhibitor of CYP2D isoenzymes), since it increases plasma melatonin levels by inhibiting the latter.

— Smoking can reduce melatonin concentrations due to the induction of the CYP1A2 isoenzyme.

- Caution should be exercised in patients taking estrogens (for example, contraceptives or hormone replacement therapy), which increase melatonin concentrations by inhibiting their metabolism by CYP1A1 and CYP1A2 isoenzymes.

- Inhibitors of CYPA2 isoenzymes, such as quinolones, can increase melatonin exposure.

- Inducers of the CYP1A2 isoenzyme, such as carbamazepine and rifampicin, can reduce the plasma concentration of melatonin.

— In modern literature there is a lot of data regarding the effect of agonists/antagonists of adrenergic and opioid receptors, antidepressants, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol on the secretion of endogenous melatonin. There have been no studies of the mutual influence of these drugs on the dynamics or kinetics of melatonin.

Pharmacodynamic interaction

— While taking melatonin, you should not drink alcohol, as it reduces the effectiveness of the drug.

- Melatonin potentiates the sedative effects of benzodiazepine and non-benzodiazepine hypnotics such as zaleplon, zolpidem and zopiclone. In a clinical study, clear evidence of a transient pharmacodynamic interaction between melatonin and zolpidem was observed one hour after administration. Combined use may lead to progressive impairment of attention, memory and coordination compared to zolpidem monotherapy.

— During the studies, melatonin was prescribed together with thioridazine and imipramine, drugs that affect the central nervous system. In none of the cases was there a clinically significant pharmacokinetic interaction. However, concomitant use with melatonin resulted in increased feelings of calmness and difficulty performing certain tasks compared with imipramine monotherapy, as well as increased feelings of brain fog compared with thioridazine monotherapy.

Analogues of Imovan

Level 4 ATX code matches:
Sonnat

Relaxon

Ivadal

Sanval

Zolpidem

Somnol

Andante

Zopiclone

The following analogues of Imovan are available in pharmacies:

• Zopiclone;
• Zopiclone-ZN;
• Normason;
• Piklon;
• Somnol;
• Sonnat;
• Sonovan.

Imovana price, where to buy

People often ask on forums where to buy Imovan in Moscow, St. Petersburg and other Russian cities. The product can be obtained in the pharmacy chain with a doctor’s prescription, but it cannot be found in any online pharmacy, since it is dispensed only when prescribed by a specialist.

You can buy the medicine in pharmacies for approximately 250 rubles. In some cities, the price of Imovan may be lower.

In Ukraine, the product is more expensive. The average price of Imovan is approximately 100 hryvnia.

• Online pharmacies in KazakhstanKazakhstan