Sleeping pills Imovan. Sleeping pill Imovan Sanofi-Aventris France - “Imovan: instructions for use, price and my experience


Clinical and pharmacological group: Sleeping pills


pharmachologic effect


Imovan is the first representative of a new class of psychotropic drugs, cyclopyrrolones, structurally different from benzodiazepines and barbiturates. The sedative-hypnotic effect of Imovan is due to high degree affinity for binding sites on the GABA receptor complex in the central nervous system.


Pharmacokinetics


Imovan quickly induces sleep without reducing the proportion of REM sleep in its structure and then supports sleep while maintaining normal phase composition.


Imovan is characterized short time half-life from the body, usually 5.5-6 hours. Repeated use of Imovan is not accompanied by accumulation of the product or its metabolites. The absence of fatigue or drowsiness in the morning distinguishes Imovan from benzodiazepine and barbiturate products.


Indications



  • Imovan is indicated for the treatment of sleep disorders, including difficulty falling asleep, night awakenings and early awakenings, transient, situational and chronic insomnia, also secondary sleep disorders with mental disorders in situations where they significantly worsen the condition of the sick.

Long-term use of Imovan, like other sleeping pills, is not recommended; the course of treatment should not exceed 4 weeks.



Treatment of elderly people should begin with a lower dose - 3.75 mg.


Depending on the effectiveness and tolerability, the dose may be increased in the future.


Renal dysfunction does not require a dose reduction of Imovan


In patients with severe liver failure The recommended dose of Imovan is 3.75 mg.


Side effect


The most common side effect of treatment with Imovan is a feeling of a moderately bitter or metallic taste in the mouth, less common are gastrointestinal disorders(nausea, vomiting) and mental disorders(irritability, confusion, depressed mood).


Allergic manifestations (urticaria, rash) were observed very rarely.


When waking up, you may experience drowsiness, less often dizziness and loss of coordination. Although such effects are rare and mild, patients should drive and operate machinery with caution the next day.


Contraindications



  • allergy to the product,


  • decompensated.

Pregnancy and lactation



special instructions


Avoid using Imovan during pregnancy and breastfeeding.


Abruptly stopping use of the product does not cause withdrawal effects. As with all sleeping pills, one should beware of alcohol and other central inhibitors. nervous system.


Zopiclone reduces the concentration of trimipramine, which must be kept in mind when prescribing them simultaneously.


Serious or persistent unwanted effects in several cases, no overdose was observed.


Overdose


Data not provided.


Drug interactions


Reduces the concentration of trimipramine.


Enhances the effect of alcohol and other central nervous system depressants.


Storage conditions and periods


At room temperature.


Shelf life: 3 years.

Attention!
Before using the medication "Imovane" You should consult your doctor.
The instructions are provided for informational purposes only. Imovane"Did you like the article? Share with friends on social networks:

A hypnotic from the group of cyclopyrrolan derivatives.
Drug: IMOVAN®
Active substance drug: zopiclone
ATX encoding: N05CF01
KFG: Sleeping pill
Registration number: P No. 015904/01
Registration date: 10/26/04
Owner reg. cert.: Laboratoires AVENTIS (France)

Imovan release form, drug packaging and composition.

Film-coated tablets
1 tab.
zopiclone
7.5 mg

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

DESCRIPTION OF THE ACTIVE SUBSTANCE.
All information provided is provided for information only about the drug; you should consult your doctor about the possibility of use.

Pharmacological action of Imovan

A hypnotic from the group of cyclopyrrolan 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 of the drug.

Quickly and completely absorbed from the gastrointestinal tract. Cmax is reached within 1-3 hours. Easily passes through histohematic barriers, including the BBB, and spreads throughout organs and tissues, incl. brain. T1/2 - 5.5-6 hours; does not accumulate.

Indications for use:

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

Dosage and method of administration of the drug.

The average therapeutic dose is 7.5 mg orally at night; in cases of severe insomnia, 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 of Imovan:

From the outside digestive system: bitter or metallic taste in the mouth, dry mouth, nausea, vomiting.

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

Dermatological reactions: skin rash.

Contraindications to the drug:

Severe respiratory failure, pregnancy, lactation ( breast-feeding), children's and adolescence up to 15 years old, increased sensitivity to zopiclone.

Use during pregnancy and lactation.

Zopiclone is contraindicated for use during pregnancy and lactation (breastfeeding).

Special instructions for use of Imovan.

Prescribe with caution in severe liver failure.

The risk of drug dependence is minimal if the duration of use of zopiclone does not exceed 4 weeks. However, potential danger the development of dependence on zopiclone exists.

During the treatment period, alcohol consumption should be avoided.

Impact on the ability to drive vehicles and operate machinery

The day after taking the drug, you should drive a car and operate machinery with caution.

Interaction of Imovan with other drugs.

At simultaneous use reduces the plasma concentration of trimipramine and its effect.

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

Latin name: Imovane
ATX code: N05C F01
Active substance: zopiclone
Manufacturer: Sanofi-Aventis (France)
Dispensing from the pharmacy: on prescription
Storage conditions: at temperatures up to 30 °C
Best before date: 3 years

Imovan is a hypnotic drug for the elimination of temporary or chronic sleep disturbances in adults. Normalizes the process of falling asleep, prevents nighttime and early awakenings, prolongs the night's rest cycle. Does not cause headaches, a feeling of weakness, or lethargy after waking up in the morning.

After taking the tablet, sleep occurs within 30 minutes and lasts up to 8 hours. In people suffering from asthma, the drug reduces the number of night and early morning attacks and makes them easier. Addiction to Imovan develops slowly and may begin to appear after a 4-month course of use.

The indication for the use of Imovan is temporary or chronic insomnia, inability to fall asleep, and frequent awakenings at night.

Composition, release form of the drug

  • 7.5 mg zopiclone
  • Auxiliary components: wheat starch, calcium hydrogen phosphate dihydrate, E 572, lactose (in the form of monohydrate), sodium KMC (type A)
  • Composition of shell components: hypromellose, E 171, macrogol-6000/PEG/Opadry OY-38906.

Imovana tablets are ellipse-shaped pills in a white coating. A fault line is marked on one of the surfaces. The drug is packaged in blisters of 10 or 20 pieces. Cardboard packs are supplied with 2 blisters of 10 tablets each. or 1 plate with 20 tables, accompanying description and instructions.

Medicinal properties

A hypnotic, the effect of which is provided by the main component - zopiclone. The substance belongs to the group of cyclopyrrolones. After ingestion, it has several effects simultaneously: hypnotic, sedative, tranquilizing, muscle relaxant, anticonvulsant.

The therapeutic effect is achieved by the action of zopiclone on specific receptors of the GABA complex. Thanks to the triggered mechanism, it is easier for patients to fall asleep, the time of uninterrupted night rest is extended, and the number of night awakenings is minimized.

After oral administration, the substance is absorbed from high speed, its peak plasma concentration is formed after one and a half to two hours. The absorption of a substance with a hypnotic effect does not depend on the time of meal and gender.

The amount of zopiclone that binds to plasma proteins is about 45% of the taken dosage of the sleeping pill. The substance forms two metabolites, one of which is active – an N-oxide derivative.

The substance and its metabolites are excreted from the body mainly (80%) by the kidneys, the rest (16%) - with feces. In patients with diseases or functional impairment kidney excretion process is lengthened.

Directions for use and dosage regimen

It is recommended to take Imovan tablets, according to the instructions for use, in the shortest possible course. The longest acceptable use is 4 weeks. The possibility of extending treatment is determined by the treating somnologist.

You need to take the pills whole, preferably in bed.

  • The recommended dosage for adults is 1 tablet (7.5 mg).
  • For patients with liver and/or kidney pathologies at the beginning of therapy - ½ table. (3.75 mg). The need to increase the dosage is determined individually, but maximum amount should not be higher than 7.5 mg.

Use during pregnancy or breastfeeding

Testing of the properties of Imovan on animals was not recorded harmful effects on the development of offspring. But there has been no targeted study of its effect on pregnant women, and therefore there is insufficient evidence of its safety. When studying substances with similar effects (benzodiazepines), the following effects from the use of zopiclone can be assumed:

  • Decline motor activity fetal disorder heart rate(after taking sleeping pills in 2-3 trimesters)
  • After a pregnant woman takes low dosages of Imovanaa, hypotension, a disorder of the sucking reflex, and subsequent loss of body weight occur (this goes away within 1-3 weeks as the drug is removed from the newborn’s body). If a woman took Imovan tablets in large doses, then the child may experience withdrawal syndrome, a reversible disruption of the breathing process, elevated temperature, apnea, excitability, trembling of the head and limbs. The duration of side effects in a child after taking Imovan by a pregnant woman depends on the duration of elimination of zopiclone from his body.

Considering the possibility negative influence sleeping pills on the child’s health, taking Imovan is prohibited during pregnancy.

Breastfeeding women should also not combine taking pills and lactation. If it is not possible to discontinue the medication, breastfeeding should be abandoned.

Contraindications and precautions

Average price: (20 pcs.) – 272 rubles.

The use of Imovana is prohibited for:

  • Personal hypersensitivity to the components of sleeping pills, as well as to wheat products (due to the presence of gluten in them)
  • Myasthenia gravis in severe form
  • Severe respiratory disorders
  • Sleep apnea
  • Under 18 years of age
  • Congenital intolerance to galactose, lack of lactase in the body, GG malabsorption syndrome
  • Pregnancy, GW.

The use of Imovan requires caution if the patient has functional impairment liver, kidneys and/or respiratory organs, a history of drug and/or alcohol addiction, undergoing therapy with drugs that depress the central nervous system.

The hypnotic has a depressant effect on the central nervous system, so in some patients it may daytime drowsiness, absent-mindedness, and lethargy persist. During therapy with Imovan, you should refrain from driving vehicles and other activities related to high risk for health and life.

Drug interactions

During therapy with Imovan, it is necessary to take into account the features of combination with various medications:

  • Sleeping pills must not be combined with ethyl alcohol, since the substance enhances the sedative effect of Imovan.
  • The drug is not recommended to be taken together with Erythromycin and drugs that suppress the central nervous system (tranquilizers, other sleeping pills, antidepressants, narcotic painkillers, anticonvulsants).
  • Zopiclone, when combined with trimipramine, will reduce its content in the body and thereby weaken the effect.
  • Since the metabolism of Imovan is carried out using the CYP3A4 isoenzyme, when combined with CYP3A4 inhibitor drugs, the plasma concentration of zopiclone increases, and when combined with inducers, it decreases.

Side effects and overdose

Taking Imovan may cause dysfunction internal systems and organs, manifesting themselves with different intensities.

Psychotic disorders:

  • Development of anterograde amnesia (forgetting events after starting to take Imovan)
  • Behavioral disorders (aggression, agitation, altered consciousness, etc.)
  • Dependence (after cessation of therapy - withdrawal syndrome in the form of rebound insomnia)
  • A state similar to intoxication, headaches, euphoria or depression, slurred speech, muscle spasms, lack of coordination
  • Hallucinations, confusion, drowsiness (mainly in elderly patients), nightmares, tension
  • Libido disorder.

In addition to these side effects, the appointment of Imolvan may provoke others. negative reactions body:

  • CVS: rapid heartbeat
  • Skin: rash, itching, multiform or malignant exudative erythema, heavy sweating. The appearance of these signs is grounds for discontinuation of the drug.
  • Organs of vision: double vision, lack of vision in one eye
  • Respiratory system: dyspnea
  • Immune system: urticaria, angioedema, anaphylaxis
  • Systemic reactions: muscle weakness, chills, fast fatiguability, increased sweating
  • Gastrointestinal tract: digestive disorders, coating on the tongue, bad breath, nausea, dry mucous membranes oral cavity, vomiting, abnormal stool, lack or increased appetite
  • Lab tests: high liver enzymes
  • Elderly patients: increased heart rate, nervous excitement, tremor, feeling of heaviness in the limbs, muscle weakness.

Accidental or deliberate reception large quantity medicines Imovana causes conditions from severe drowsiness to coma. Light form An overdose is manifested not only by drowsiness, but also by confusion and apathy. Severe forms intoxication provokes ataxia, a sharp decline pressure, severe respiratory depression, coma.

An overdose is easier to tolerate if it is not combined with taking other drugs that suppress the functioning of the central nervous system (tranquilizers, sleeping pills, antidepressants, etc.) or alcohol. A fatal outcome can be caused by combining overdoses of Imovan with other drugs, alcohol, or the presence of risk factors (illness, exhaustion).

To eliminate an overdose, gastric lavage, inducing vomiting (if no more than an hour has passed since poisoning), taking activated carbon. In other cases, treatment of overdose is carried out in clinical settings. In addition to symptomatic therapy, therapy is prescribed to maintain vital important functions body (breathing and cardiovascular system). It is possible to prescribe Flumazenil, which is considered an antidote to zopiclone.

Analogues

Insomnia can be eliminated with the help of other drugs with zopiclone or another active substance. Substitutes: Zolinox, Zopiclone, Somnol, Milovan, etc.

Gedeon Richter (Hungary)

Average price: caps. (7 pcs.) – 503 rub.

Sleeping pill based on zaleplon for the correction of severe sleep disorders. Available in capsules containing 5 and 10 mg of active substance. The medicine can be used from the age of 18.

Capsules are taken immediately before bed, two hours after meals, or in cases of prolonged inability to sleep. Dosage regimen – 1 capsule, course – no more than 2 weeks.

Pros:

  • Soft fall asleep
  • No headache in the morning
  • The effect of treatment lasts for several months.

Flaws:

  • Addictive.
P NO 15904/01-080410

Tradename: Imovan ®

International nonproprietary name:

zopiclone

Dosage form:

film-coated tablets.

Compound
One tablet contains: Active substance: zopiclone 7.5 mg.
Excipients: wheat starch, calcium hydrogen phosphate dihydrate, lactose monohydrate, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose, titanium dioxide (E 171).

Description: oval film-coated tablets, white, with a risk to one side.

Pharmacotherapeutic group Sleeping pill.

CodeATX: N05CF01.

Pharmacological properties
Pharmacodynamics

The drug belongs to list No. 1 potent PKKN substances.
Zopiclone is a hypnotic drug from the cyclopyrrolone group. It has the following pharmacological properties: hypnotic, sedative, tranquilizing, anticonvulsant and muscle relaxant. These effects of zopiclone are associated with a specific agonistic effect on the omega receptors (formerly known as benzodiazepine receptors type I and type II), related to the macromolecular GABA-omega complex that modulates the opening of neuronal ion channels for chloride.
Zopiclone has the ability to reduce the time to fall asleep and the frequency of night and early awakenings, increase the duration of sleep and improve the quality of sleep and awakening. These effects, when used in recommended doses, are combined with a characteristic electroencephalographic profile that differs from that recorded when taking benzodiazepines. Polysomnography data have demonstrated that in patients with insomnia, zopiclone reduces stage I and prolongs stage II sleep, along with maintaining or prolonging stages of deep sleep (III and IV) and paradoxical (REM) sleep.
An objective study of the withdrawal syndrome using polysomnogram recording did not reveal significant rebound insomnia after 28 days of taking the drug. Other studies have demonstrated that there is no loss of hypnotic effects when the drug is taken for up to 17 weeks.

Pharmacokinetics
Absorption
Zopiclone is rapidly absorbed. Eating does not affect absorption. Maximum plasma concentrations are achieved within 1.5-2 hours and are approximately 30 and 60 ng/ml after oral administration of 3.75 mg and 7.5 mg, respectively. Absorption of the drug does not depend on gender.
Distribution
The 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. The drug is rapidly distributed from the systemic circulation. The volume of distribution is 91.8-10.4 liters.
Drug concentrations in breast milk similar to those in plasma. According to calculations, the intake of the drug into the baby’s body through breast milk will not exceed 1% of the dose taken by the mother within 24 hours.
Metabolism
After repeated appointments drug accumulation of zopiclone and its metabolites does not occur.
Interindividual differences are insignificant.
In humans, zopiclone is extensively metabolized to two major metabolites: zopiclone N-oxide and zopiclone N-demethyl. In vitro studies have shown that cytochrome P450 (CYP) 3A4 is the main isoenzyme through which zopiclone is metabolized and both metabolites are formed. In addition, the CYP2C8 isoenzyme is involved in the metabolism of zopiclone, through which a second metabolite (N-demethyl zopiclone) is also formed. The half-life of these metabolites based on urinary excretion is approximately 4.5 and 7.4 hours, respectively.
Removal
At recommended doses, the elimination half-life of unchanged zopiclone is approximately 5 hours. Low values The renal clearance of unchanged zopiclone (8.4 ml/min) compared with its plasma clearance values ​​(232 ml/min) indicate that the clearance of zopiclone is predominantly metabolic.
Zopiclone is excreted in the urine mainly in the form of free metabolites (N-oxide and N-demethyl derivatives), (approximately 80%) and with feces(approximately 16%).
Separate groups of patients

  • Elderly patients
    Despite a slight decrease in hepatic metabolism and an extension of the half-life to approximately 7 hours, even with repeated administration, no accumulation of the drug in plasma was detected.
  • Patients with renal failure
    Even after long-term use, no accumulation of zopiclone or its metabolites was detected. Zopiclone penetrates the dialysate membrane, but hemodialysis is ineffective in treating overdose due to the large volume of distribution of zopiclone.
  • Patients with liver failure
    In patients with liver cirrhosis, the clearance of zopiclone is reduced by approximately 40%, consistent with a decrease in demethylation. Therefore, such patients require dose adjustment of the drug. Indications
    Treatment of transient, situational and chronic insomnia in adults (including difficulty falling asleep, nighttime and early awakenings). Contraindications
  • Hypersensitivity to zopiclone or other components of the drug.
  • Severe pseudoparalytic myasthenia gravis (myasthenia gravis).
  • Severe respiratory failure.
  • Severe liver failure (acute and chronic) (risk of developing encephalopathy).
  • Severe sleep apnea syndrome.
  • Age up to 18 years.
  • Hypersensitivity or intolerance to gluten, as the drug contains wheat starch.
  • Galactose intolerance, lactase deficiency or glucose-galactose malabsorption. Carefully
    In persons with a history of alcohol, drug or drug addiction, patients simultaneously taking alcohol or other psychotropic substances or drugs ( increased risk development of dependence or abuse). Pregnancy and lactation
    It is not recommended to use the drug during pregnancy and for nursing mothers.
    If zopiclone is used during the third trimester of pregnancy or during childbirth, due to pharmacological effects The drug can be expected to cause hypothermia, hypotension and respiratory depression in a newborn.
    In the case of prescribing the drug Imovan ® to women childbearing age, they should be warned that if they are planning or suspect pregnancy, they should consult their doctor about stopping taking the drug. Directions for use and doses
    Inside.
    Treatment should be short-term if possible and not exceed four weeks, including the period of dose reduction. Extension of treatment beyond the maximum permissible is carried out after re-evaluation of the patient’s condition. Treatment should always begin with the lowest effective dose and never exceed maximum dose. The drug is taken immediately before going to bed at night.
    Duration of treatment
  • Transient insomnia: 2 to 5 days (for example, caused by a change of location while traveling).
  • Situational insomnia: 2 to 3 weeks.
  • Chronic insomnia: long-term treatment prescribed after consultation with a specialist.
    Recommended Doses
  • For adults (under 65 years of age): the recommended daily dose is 7.5 mg.
  • For elderly patients (over 65 years), patients with impaired liver function or respiratory failure medium degree severity: the recommended daily dose is 3.75 mg. Only in exceptional cases the daily dose can be increased to 7.5 mg.
  • For patients with renal failure: although no accumulation of the drug or its metabolites has been detected in renal failure, treatment of patients with renal failure should begin with a dose of 3.75 mg per day.
    In all cases, the daily dose of Imovan ® should not exceed 7.5 mg Side effect
    Bitter taste in the mouth (most common by-effect observed with zopiclone).
    Dizziness, headache, residual drowsiness after waking up; muscle hypotonia, asthenia, decreased libido, diplopia.
    Digestive disorders: dyspepsia, nausea, dry mouth.
    Allergic skin reactions , such as itching and rashes, are extremely rare angioedema and/or anaphylactic reactions.
    Anterograde amnesia
    Anterograde amnesia may also occur (the risk of its occurrence increases in proportion to the dose).
    Mental and paradoxical reactions
    Rarely: nightmares, irritability, confusion, hallucinations, aggressiveness, depressed mood, incoordination, depression, inappropriate behavior, which can be combined with amnesia, sleepwalking.
    Physical and mental dependence (even when used in therapeutic doses)
    Withdrawal syndrome was observed after cessation of treatment (see also “Special Instructions”).
    Its symptoms vary and may include rebound insomnia, restlessness, tremors, excessive sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations and irritability. In very rare cases, it is possible to develop seizures.
    Increased liver enzymes
    Isolated cases of slight increases in serum concentrations of transaminases and/or alkaline phosphatase. Overdose
    Signs and symptoms
    Overdose usually manifests itself as symptoms varying degrees depression of the central nervous system from drowsiness to coma, depending on the amount taken drug. In mild cases, symptoms include drowsiness, confusion, and apathy. In more severe cases, symptoms may include ataxia, lethargy, hypotension, respiratory depression, and coma. Rarely - atrioventricular block. An overdose does not pose a threat to life unless combined with the use of other drugs that have a depressant effect on the central nervous system (including alcohol). Other risk factors, such as concomitant illness and debilitated condition of the patient, can increase symptoms and even (very rarely) lead to death.
    Treatment
    If necessary, symptomatic and supportive therapy in a hospital setting is recommended. Special attention should be given to respiratory and cardiovascular functions. Gastric lavage or the use of activated charcoal is effective only if carried out soon after taking the drug.
    Hemodialysis is of little importance due to the large volume of distribution of zopiclone. Flumazenil can be used as an antidote. Drug interactions
    With alcohol
    Alcohol may increase the sedative effect of zopiclone. Not recommended simultaneous administration zopiclone and alcohol.
    With drugs that depress the central nervous system: antipsychotics, barbiturates, hypnotics, tranquilizers, sedatives, antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), narcotic analgesics and antitussives (except buprenorphine, interaction with buprenorphine, see below ), antiepileptic drugs, anesthetics, antihistamines with a sedative effect, antihypertensive drugs central action, baclofen, thalidomide, pizotifen
    At joint use These drugs with zopiclone may enhance the inhibitory effect on the central nervous system, including respiratory depression (especially when using morphine derivatives and barbiturates).
    With trimipramine
    In addition to the above, zopiclone reduces the plasma concentration of trimipramine and its effect.
    With buprenorphine
    Increased risk of respiratory depression, up to fatal outcome.
    With CYP3A4 inhibitors such as erythromycin, clarithromycin, ketoconazole, itraconazole and ritonavir.
    Because zopiclone is metabolized by CYP3A4, CYP3A4 inhibitors may increase plasma concentrations of zopiclone. If they are administered simultaneously, a dose reduction of zopiclone may be necessary.
    The effect of erythromycin on the pharmacokinetics of zopiclone was studied in 10 healthy volunteers. The area under the pharmacokinetic curve (concentration-time) of zopiclone increased by 80% in the presence of erythromycin.
    With CYP3A4 inducers: such as rifampicin, carbamazepine, phenobarbital, phenytoin, St. John's wort.
    Because zopiclone is metabolized by CYP3A4, inducers of CYP3A4 may decrease plasma concentrations of zopiclone. If they are administered simultaneously, an increase in the dose of zopiclone may be required. special instructions
    The use of sedative/hypnotic drugs, such as zopiclone, can lead to physical and psychological dependence and abuse. The risk of developing dependence or abuse increases if:
  • increasing the dose and duration of treatment;
  • abuse of alcohol and/or other substances or medicines; use in combination with alcohol or other psychotropic substances or drugs;
  • presence of anxiety.
    If physical dependence occurs, abrupt cessation of treatment may cause the development of withdrawal syndrome (see “Side Effects”).
    Rebound insomnia
    In response to treatment withdrawal sleeping pills A temporary syndrome may develop when the symptoms that led to the need to prescribe sedatives (hypnotics) arise with increased severity.
    Since the risk of developing this phenomenon is higher in case of abrupt withdrawal of zopiclone, especially after long-term treatment, it is necessary to reduce the dose of the drug gradually and inform the patient about the possibility of occurrence and measures to prevent the development of rebound insomnia.
    Amnesia
    Anterograde amnesia may occur, 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 anterograde amnesia, you must:
  • take the tablet immediately before going to bed at night;
  • ensure a sleep duration of at least 6 hours.
    Depression
    The drug is not indicated for the treatment of depression, and may even mask its symptoms.
    Use in children
    A safe and effective dose of zopiclone in children and young people under 18 years of age has not been established.
    Other mental and paradoxical reactions
    Somnambulism and associated behaviors: sleepwalking and other associated behaviors, such as sleep-driving, preparing and eating food, talking on the phone with amnesia about what happened, have been described in patients using zopiclone and not completely awakened. The use of alcohol and other drugs that depress the central nervous system with zopiclone increases the risk of developing this disorder, similar to what happens when zopiclone is used in doses exceeding the maximum daily dose. With such behavioral disturbances, drug discontinuation will most likely be required. Impact on the ability to drive and manage transport
    Because of their pharmacological properties Zopiclone may have adverse influence on the ability to drive and control vehicles, therefore, during the period of treatment it is necessary to refrain from this. Release form
    Film-coated tablets 7.5 mg
    10 tablets per blister made of PVC/aluminum foil.
    2 blisters along with instructions for use are placed in a cardboard box.
    20 tablets in a blister made of PVC/aluminum foil. The blister along with instructions for use is placed in a cardboard box. Best before date
    3 years.
    Do not use after the expiration date stated on the package. Storage conditions
    In a dry place, at a temperature not exceeding 30° C.
    Keep out of the reach of children.
    List No. 1 of potent substances of PKKN. Conditions for dispensing from pharmacies
    On prescription. Owner registration certificate
    SANOFI-AVENTIS FRANCE, France 1-13, Boulevard Romain Rolland 75014 Paris, France Manufacturer
    Sanofi Winthrop Industrie, France 56, rue de Choisy le Bac 60205 Compiègne, France. Consumer complaints should be sent to:
    115035, Moscow, st. Sadovnicheskaya, 82, building 2
  • The medication "Imovan" instructions for use defines how sleeping pill, belonging to the group of cyclopyrrolones. The drug has tranquilizing, hypnotic, muscle relaxant, sedative, and anticonvulsant properties.

    Pharmacodynamics

    The therapeutic effect of the drug "Imovan" (the instructions indicate this) is associated with an agonistic specific effect on omega receptors (previously they were called benzodiazepine receptors of the first and second types). The medication allows you to reduce the time before falling asleep and reduce the frequency of early and night awakenings, as well as increase the duration and improve the quality of sleep. Polysomnography data demonstrate that the drug “Imovan” in patients suffering from insomnia shortens the first phase of sleep and prolongs the second, while preserving the third and fourth ( deep dream) stage and paradoxical ( REM sleep) phase. A withdrawal polysomnogram study did not reveal significant rebound insomnia after taking the medication for twenty-eight days. Other tests have shown that when using the medication for seventeen weeks, the disappearance of the hypnotic effect is not observed.

    Pharmacokinetics

    The sleeping pill "Imovan" is absorbed quickly, regardless of food intake. In blood plasma, with oral administration of 3.75 and 7.5 milligrams of the drug, the highest concentrations are reached within one and a half to two hours, being approximately 30 and 60 ng/ml, respectively. The connection with blood plasma proteins is unsaturated and weak (about 45%). At the level of protein binding, the risk of interaction with other drugs is very low. The drug “Imovan” is distributed quite quickly from the systemic bloodstream. The instructions indicate that its concentrations in breast milk are similar to those observed in plasma. Half-life medicine unchanged when taken in recommended doses is an average of five hours. The drug is predominantly excreted as metabolites in urine (about 80%) and feces (about 16%).

    Indications for use

    The instructions for the drug “Imovan” indicate its use in the treatment of situational, transient, chronic insomnia in adults. In particular, it is used for difficulties falling asleep, early and night awakenings.

    Release form and composition

    The medicine is available in the form of white film-coated oval tablets with a score on one side. One unit of the product includes active ingredient- zopiclone - weighing 7.5 milligrams. Imovan tablets also contain sodium carboxymethyl starch, titanium dioxide, calcium hydrogen phosphate dihydrate, magnesium stearate, lactose monohydrate, wheat starch, hypromellose.

    Method of administration and duration of treatment

    Oral administration of the medication is indicated immediately before bedtime. If possible, therapy should be short-term and not exceed four weeks, including the period of reduced dosage. Taking the drug for a longer time than prescribed is allowed only after a specialist has assessed the patient’s condition. You should always start therapy with the minimum effective dose, increasing it if necessary, but you should not exceed the maximum permissible dose. For transient insomnia (for example, caused by a change of place during a trip), the course of treatment does not exceed two to five days. For situational insomnia it is two to three weeks. In the case of chronic insomnia, long-term therapy is required, its duration is determined by the doctor.

    The daily dose for people under 65 years of age is 7.5 milligrams. Elderly patients (over 65 years of age) and those who have liver problems or moderate respiratory failure are prescribed 3.75 milligrams per day. Taking the medicine in a mass of more than 7.5 milligrams per day is allowed only in extreme cases. Treatment of patients with renal failure, despite the fact that in this case the accumulation of the drug and its metabolites was not detected, should be started with a daily dose of 3.75 milligrams.

    Side effects

    There are reviews about the drug "Imovan" for the most part positive, it is often well tolerated. But almost all patients note that after taking the medicine a bitter taste remains in the mouth. Some people report headaches and dizziness while using sleeping pills. Possible negative effects also include muscle hypotonia, residual drowsiness after waking up, diplopia, asthenia, and decreased libido. There is a risk of developing digestive disorders: nausea, dyspepsia, dry mouth. Sometimes skin reactions appear, such as rashes and itching, in very rare cases - anaphylactic reactions, angioedema. Some patients, after taking sleeping pills, experience hallucinations, depression, problems with coordination of movements, aggressiveness, irritability, depressed mood, sleepwalking, inappropriate behavior (can be observed in combination with amnesia). Even when used in therapeutic doses of Imovan tablets (the instructions warn about this), mental and physical dependence may develop.

    Withdrawal syndrome

    Some people develop symptoms after stopping drug therapy. Its symptoms may vary, most often they manifest themselves in the form of anxiety, confusion, rebound insomnia, tachycardia, irritability, tremor, headache, delirium, increased nightmares, tachycardia, agitation, hallucinations. In very rare situations, seizures occur.

    Contraindications

    People who are hypersensitive to the ingredients of Imovan should avoid using it. Also, sleeping pills are not prescribed to patients with severe pseudoparalytic myasthenia, severe liver failure (with a risk of encephalopathy), severe apnea syndrome in sleep, severe respiratory failure. The drug is contraindicated in people under the age of eighteen. For persons with a history of drug, alcohol, or drug dependence, the medication is prescribed with caution, since in this case there is an increased risk of increased dependence or abuse.

    Use during pregnancy and lactation

    Pregnant and lactating women are not recommended to take the sleeping pill Imovan. When using the medicine in the third trimester, the newborn may develop such negative effects as hypotension, respiratory depression, hypothermia. Women planning or suspecting pregnancy should stop taking the medication.

    Overdose

    Typically, an overdose is manifested by symptoms of central nervous system depression to varying degrees: from simple drowsiness to coma (depending on the dose taken). In mild cases, apathy, drowsiness, and confusion appear; in more serious cases, lethargy, respiratory depression, ataxia, hypotension, and coma appear. Atrioventricular block occurs extremely rarely. An overdose does not pose a threat to life if taking sleeping pills is not combined with taking other drugs that depress the central nervous system or alcohol. Overdose symptoms may also worsen if general state the patient is weakened or has accompanying illnesses. In such cases it is even possible fatal outcome(rarely). When taking the drug in excessive doses, symptomatic and supportive treatment in a hospital is indicated. In this case, the greatest attention should be paid to cardiovascular and respiratory functions. Such measures, like gastric lavage, will be effective only if they are carried out soon after using the drug “Imovan”.

    Analogues

    Generics of this sleeping pill are drugs such as Somnol, Thorson, Relaxon, Piclodorm and others. As a rule, they are cheaper than the original, but at the same time they are less effective.

    special instructions

    As mentioned earlier, reception sedatives, including the drug "Imovan", can lead to the development of psychological and physical dependence. The risk increases with long-term treatment and taking sleeping pills in high doses, abuse of alcohol, psychotropic substances, and anxiety. If, when physical dependence appears, you abruptly stop drug therapy, the drug described above may develop. To avoid this, you need to reduce the dose of the medication gradually. Prevent the risk of such side effect How will following two rules help: you should take the pill immediately before bed (do not allow a long period of time between taking the medicine and going to bed) and sleep for at least six hours (do not interrupt your sleep earlier than six hours after falling asleep). The medication is not indicated for therapy depressive states and may even mask their symptoms.

    Drug interactions

    Simultaneous use of the sleeping pill "Imovan" and alcohol can lead to increased sedative effect, tranquilizers, neuroleptics, antitussives, anesthetics, narcotic analgesics, antiepileptic drugs with central action. If they are used together, the depressant effect on the central nervous system may increase. Also, you should not take Imovan tablets together with drugs containing trimipramine, because the plasma concentration of the latter and its effect will be reduced. Taking a sleeping pill together with buprenorphine increases the risk of respiratory depression (which can even be fatal).

    Where to buy "Imovan"

    The drug is sold in most pharmacies. Sleeping pills are available with a doctor's prescription. Some people who want to buy medication without a prescription resort to online pharmacies. However, you should remember that in this case you risk purchasing a low-quality, counterfeit or expired product.