Zopiclone Mylan



ZOPICLONE MYLAN7.5 mg film-coated tablets

What is Zopiclone Mylan?

Zopiclone Mylan belongs to the class of medications called sedative-hypnotics. It is used for the short-term and symptomatic relief of sleep disturbances. Zopiclone Mylan can help with difficulty falling asleep, frequent wake-ups during the night, or early morning awakenings.


Zopiclone Mylan ………………………………………… …………………….. 7.5 mg

For a scored film-coated tablet.

Excipient with known effect: anhydrous lactose (30.8 mg).


Divisible coated tablet.


4.1. Therapeutic indications  

The indications are limited to the short-term treatment of severe sleep disorders in adults:

  • Occasional insomnia,
  • Transient insomnia.

4.2. Posology and method of administration  



In all cases, treatment will be started at the lowest effective dose and the maximum dose will not be exceeded.

ZOPICLONE MYLAN 7.5 mg film-coated tablets should be taken as a single dose at bedtime at night , and should not be administered again during the same night.

The 3.75 mg dosage is more particularly suitable for subjects over 65 years of age and populations at risk.

The usual dosage is:

  • Adults less than 65 years: 7.5 mg daily;
  • Patient over 65 years of age: the recommended dosage is 3.75 mg per day and may only exceptionally be increased to 7.5 mg;

– subject with hepatic insufficiency or in the event of moderate respiratory insufficiency: the recommended dosage is 3.75 mg per day .

– subject with renal impairment: it is recommended to start treatment with 3.75 mg per day.

In any case, the dosage should not exceed 7.5 mg per day.

Pediatric population

The safety and efficacy of Zopiclone Mylan  have not been demonstrated in children and adolescents under 18 years of age. Therefore, zopiclone is not recommended in this population.


Treatment should be as brief as possible. It should not exceed 4 weeks , including the dose reduction period.

The duration of treatment should be presented to the patient:

  • 2 to 5 days in the event of occasional insomnia (such as during a trip);
  • 2 to 3 weeks in case of transient insomnia (such as upon the occurrence of a serious event).

In some cases, it may be necessary to extend the treatment beyond the recommended periods; this prolongation beyond the recommended periods should not take place without reassessment of the patient’s condition, since the risk of abuse and dependence increases with the duration of treatment .

Administration mode

Oral route.

4.3. Contraindications  

This medication should never be used in the following situations:

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. ;
  • Severe respiratory failure;
  • Sleep apnea syndrome;
  • Severe hepatic insufficiency, acute or chronic (risk of encephalopathy occurred);
  • Gravis;

– history of complex sleep behaviors after taking zopiclone

4.4. Special warnings and precautions for use  


Pharmacological tolerance

The sedative or hypnotic effect of benzodiazepines and related drugs may gradually decrease despite the use of the same dose when administered for several weeks.

No notable tolerance has been observed with ZOPICLONE MYLAN, for treatment durations of up to 4 weeks.


Any treatment with Zopiclone Mylan may lead to the development of abuse and / or a state of physical and mental drug dependence.

The risk of dependence increases with the dose and the duration of treatment. The risk of abuse and dependence is higher in patients with a history of psychiatric and / or alcoholism, drug addiction and drug abuse. Zopiclone Mylan should be prescribed with extreme caution in patients with or with a history of abuse or dependence on alcohol, drugs or medication.

Drug dependence can occur at therapeutic doses and / or in patients without an individualized risk factor.

With Zopiclone Mylan, this state of drug dependence has been reported exceptionally at therapeutic doses.

If physical dependence sets in, a sudden discontinuation of treatment will be accompanied by withdrawal symptoms, which may be headache, muscle pain, severe anxiety, tension, restlessness, confusion and irritability.

In severe cases, the following symptoms may appear: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures.

Withdrawal symptoms may appear within days of stopping treatment. For short-acting benzodiazepines, and especially if given in high doses, symptoms may even appear in the interval between two doses.

The combination of several benzodiazepines, whatever the anxiolytic or hypnotic indication, may increase the risk of drug dependence.

Cases of abuse have been reported.

Rebound phenomenon

This transient syndrome may manifest as an exacerbation of insomnia that prompted treatment with benzodiazepines and related drugs.

Alterations in psychomotor functions

Like any other sedative / hypnotic substance, Zopiclone Mylan is a central nervous system depressant.

Alterations in psychomotor functions are likely to appear within hours of taking.

The risk of impaired psychomotor functions, including the ability to drive, increases in the following situations:

  • Taking this drug within 12 hours before any activity that requires alertness ;
  • Taking a dose higher than the recommended dose;
  • Co-administration with other CNS depressants, alcohol, illegal drugs, or other drugs that increase the blood levels of Zopiclone Mylan.

Warn patients not to undertake dangerous activities requiring total vigilance or motor coordination such as using machines or driving vehicles following the intake of Zopiclone Mylan and in particular during the 12 hours following this intake.


Anterograde amnesia is likely to appear within hours of taking.

To reduce these risks, it is advisable to take the drug immediately before bedtime, or even in bed and to put yourself in the most favorable conditions for an uninterrupted sleep period of several hours (7-8 hours). .

Behavior disorders

In some individuals, benzodiazepines and related products may cause a syndrome with varying degrees of altered consciousness, behavioral and memory disturbances.

Can be observed:

  • Exacerbated insomnia, nightmares, agitation, nervousness;
  • Delusions, hallucinations, confuse-dreamlike state, psychotic-like symptoms;
  • Disinhibition with impulsivity;
  • Euphoria, irritability;
  • Anterograde amnesia;
  • Suggestibility.

This syndrome can be accompanied by potentially dangerous disorders for the patient or for others, such as:

  • Unusual behavior for the patient;
  • Auto- or hetero-aggressive behavior, especially if the entourage tries to hinder the patient’s activity;
  • Automatic behavior with post-event amnesia.

These manifestations require the discontinuation of treatment.

Sleepwalking and associated behaviors

Complex sleep behaviors, including sleepwalking and other associated behaviors such as sleepwalking, preparing and consuming food, making phone calls or having sex, accompanied by amnesia upon awakening, have been reported in patients who took Zopiclone Mylan and were not fully awake.

These things can happen after you take Zopiclone Mylan for the first time or after you use it. Zopiclone Mylan treatment should be stopped immediately if a patient exhibits complex sleep behavior due to the risk to himself and those around him .

Consumption of alcohol or other central nervous system (CNS) depressants with Zopiclone Mylan appears to increase the risk of such behaviors, as does taking zopiclone in doses above the maximum recommended dose.

Risk of accumulation

Benzodiazepines and related drugs (like all medicines) persist in the body for a period of the order of 5 half-lives.

In the elderly or those with hepatic insufficiency, the half-life may lengthen considerably. When taken repeatedly, the drug or its metabolites reach the equilibrium plateau much later and at a much higher level.

It is only after achieving a plateau of equilibrium that it is possible to assess both the efficacy and the safety of the drug.

Dosage adjustment may be necessary .

This phenomenon has not been observed in renal impairment in studies with zopiclone.

Risks Regarding Concomitant Use of Opioids

Concomitant use of benzodiazepines and other sedating hypnotic drugs, including Zopiclone Mylan, and opioids can lead to sedation, respiratory depression, coma, and death.

Because of these risks, the concomitant prescription of opioids and benzodiazepines should be reserved for patients for whom the treatment alternatives are inadequate.

If the decision is made to prescribe zopiclone concomitantly with opioids, the lowest effective dose should be prescribed, the duration of concomitant administration should be as short as possible, and the patient should be closely monitored for signs of respiratory depression and sedation.

In this regard, it is strongly recommended to inform patients and their caregivers (if applicable) so that they are aware of these symptoms .

Elderly subject

Benzodiazepines and related products should be used with caution in the elderly, because of the risk of sedation and / or muscle relaxant effect which can promote falls, with often serious consequences in this population, and because of the more frequent significant behavioral disturbances.

Special precautions for use

The greatest caution is recommended in the event of a history of alcoholism or other drug or non-drug dependence .

In all cases, the evaluation of insomnia must be systematically carried out, and its causes treated, before prescribing a hypnotic.

Insomnia can indicate an underlying physical or psychiatric disorder.

Persistence or worsening of insomnia after a short period of treatment necessitates reassessment of the clinical diagnosis.

Duration of the treatment

It should be clearly stated to the patient, depending on the type of insomnia.

Suicide – Depression – Major depressive episode

Some epidemiological studies show an increased incidence of suicidal ideation, suicide attempts and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zopiclone.

However, the causal link has not been established.

Since insomnia can be a symptom of depression, it should be treated. If insomnia persists, the patient should be reassessed.

In the subject presenting a major depressive episode:

Benzodiazepines and related drugs should not be prescribed alone because they allow depression to progress on its own with persistence or increased risk of suicide.

As the risk of suicide is present in these patients, the smallest amount of zopiclone should be made available to these patients (prescription and dispensing) in order to limit the possibility of intentional overdose.

Methods of phasing out treatment

They must be clearly stated to the patient.

In addition to the need for a gradual decrease in doses, patients should be warned of the possibility of a rebound phenomenon, in order to minimize the insomnia which could result from the symptoms associated with this interruption, even gradual.

The patient should be warned of the possibly uncomfortable nature of this phase.

Pediatric population

The safety and efficacy of  Zopiclone Mylan have not been demonstrated in children and adolescents under 18 years of age. Therefore, Zopiclone Mylan is not recommended in this population.

Insufficient breathing

In patients with respiratory insufficiency, the depressant effect of benzodiazepines and related drugs should be taken into account (especially since anxiety and agitation can constitute warning signs of decompensation of respiratory function which justifies the transfer to intensive care unit) .

Elderly subject, renal failure

No accumulation of Zopiclone Mylan has been demonstrated after prolonged use. However, as a precaution, it is recommended to reduce the dosage by half


This medicine contains lactose. Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare inherited diseases) should not take this medicine.

4.5. Interactions with other drugs and other forms of interactions  

Sedative drugs

It should be taken into account that many drugs or substances can add up their depressant effects on the central nervous system and contribute to reducing vigilance. Impaired vigilance can make driving and using machines dangerous.

These are morphine derivatives (analgesics, cough suppressants and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (for example, meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin , mianserin, mirtazapine, trimipramine), sedating H1 antihistamines, central antihypertensive drugs, baclofen and thalidomide.

Hypnotic drugs

The currently prescribed hypnotics are either benzodiazepines and related drugs (zolpidem, Zopiclone Mylan) or H1 antihistamines.

In addition to increased sedation when prescribed with other CNS depressant drugs, or in the case of alcoholic consumption, the possibility of increased respiratory depressant effect should also be taken into account for benzodiazepines when they are associated with morphinomimetics, other benzodiazepines, or phenobarbital, and this in particular in the elderly.


Concomitant use of benzodiazepines and other sedating hypnotic drugs, including zopiclone, and opioids increases the risk of sedation, respiratory depression, coma, and death due to the added depressant effects on the central nervous system.

The doses and duration of concomitant treatment with benzodiazepines and opioids should be limited .

Not recommended associations

+ Alcohol (drink or excipient)

Alcohol enhancement of the sedative effect of benzodiazepines and related drugs. Impaired alertness can make driving and using machines dangerous.

Avoid taking alcoholic drinks and drugs containing alcohol.

+ Sodium (oxybate)

Increase in central depression. Impaired alertness can make driving and using machines dangerous.

Combinations subject to precautions for use

+ Rifampicin

Decreased plasma concentrations and efficacy of Zopiclone Mylan by increasing its hepatic metabolism. Clinical monitoring. Possibly use another hypnotic.

Associations to take into account

+ Barbiturates

Increased risk of respiratory depression, which may be fatal in case of overdose.

+ Other hypnotics

Increase in central depression.

+ Other sedative drugs

Increase in central depression. Impaired alertness can make driving and using machines dangerous.

+ Buprenorphine

With buprenorphine used in substitution treatment: increased risk of respiratory depression which can be fatal.

Carefully assess the benefit / risk ratio of this combination. Inform the patient of the need to adhere to the prescribed doses.

+ Clozapine

Increased risk of collapse with respiratory and / or cardiac arrest.

+ Clarithromycin, erythromycin, telithromycin

Slightly increased sedative effects of Zopiclone Mylan.

+ Ketoconazole, itraconazole, voriconazole

Slightly increased sedative effects of Zopiclone Mylan.

+ Nelfinavir, protease inhibitor boosted by ritonavir

Slightly increased sedative effects of Zopiclone Mylan.


4.6. Fertility, pregnancy and lactation  


Many data from cohort studies have not revealed the occurrence of malformation effects when exposed to benzodiazepines during the first trimester. However, in some case-control epidemiological studies, an increased occurrence of cleft lip and palate has been observed with benzodiazepines.

According to these data, the incidence of cleft lip and palate in newborns is less than 2/1000 after exposure to benzodiazepines during pregnancy, while the expected rate in the general population is 1/1000.

If taking high-dose benzodiazepines in the second and / or third trimesters of pregnancy decreased active fetal movements and variability in fetal heart rate have been described.

Treatment at the end of pregnancy with benzodiazepines, even at low doses, may be responsible in the newborn for signs of impregnation such as axial hypotonia, sucking disorders leading to low weight gain.

These signs are reversible, but can last 1 to 3 weeks depending on the half-life of the benzodiazepine prescribed.

At high doses, respiratory depression or apnea, and hypothermia may occur in the newborn.

In addition, a neonatal withdrawal syndrome is possible, even in the absence of signs of impregnation.

It is characterized in particular by hyperexcitability, restlessness and tremors of the newborn occurring at a distance from the childbirth.

The time to onset depends on the elimination half-life of the drug and can be important when this is long.

In view of these data, as a precaution, the use of zopiclone is not recommended during pregnancy, whatever the term.

If a woman of childbearing potential is prescribed zopiclone, she should be advised of the need to contact her doctor if pregnancy is planned or started so that he or she can reassess the benefit of the treatment.

At the end of pregnancy, if it is really necessary to initiate treatment with zopiclone, avoid prescribing high doses and take into account, for the monitoring of the newborn, the effects described above.

Feeding with milk

The use of this medication during breast-feeding is not recommended.

4.7. Effects on ability to drive and use machines  

Zopiclone can significantly affect the ability to drive and use machines.

Warn drivers of vehicles and users of machines, as with any other hypnotics, of the possible risk of drowsiness, prolonged reaction time, dizziness, torpor, blurred or double vision, and decreased blood pressure.

Vigilance and impaired driving, particularly during the 12 hours following the administration of zopiclone .

To minimize this risk, an uninterrupted rest period of at least 12 hours is recommended between taking zopiclone and driving a car, using machines or working at heights.

Impaired driving ability and behaviors such as falling asleep while driving may occur with zopiclone used alone at a therapeutic dose.

In addition, these phenomena are accentuated by the concomitant intake of alcohol or other central nervous system depressants.

Patients should be instructed not to take alcohol or other psychoactive substances while taking zopiclone.

4.8. Side effects  

Adverse reactions were classified according to their incidence using the following classification:

Very common ( more than 1/10); common (more than 1/100, <1/10); uncommon (more than 1/1000, <1/100); rare (more than 1/10000, <1/1000); very rare (<1/10000); not known (frequency cannot be estimated from the available data).

They are related to the dose ingested and the individual sensitivity of the patient.

Psychiatric disorders

  • Uncommon: agitation, nightmares.
  • Rare: changes in consciousness, changes in libido, irritability, aggressiveness, aggression, hallucinations.
  • Not known: abnormal behavior, delusions, fits of anger, nervousness, complex sleep behaviors including the sleepwalking , physical dependence and psychic even with therapeutic doses withdrawal symptoms or rebound upon discontinuation of treatment , confusion, insomnia, blood pressure.

Psychotic-like symptoms, inappropriate behavior and other behavioral disturbances are possible while taking benzodiazepines and related drugs.

In rare cases, they can be significant.

These symptoms are more likely to appear in the elderly and in children.


Latent depression may develop during treatment with benzodiazepines or related drugs .

Nervous system disorders

  • Common: decreased alertness or even drowsiness (particularly in the elderly), dysgeusia.
  • Uncommon: drunkenness, headache.
  • Rare: anterograde amnesia, which may occur at therapeutic doses, increasing the risk proportionally with dose.
  • Not known: ataxia, paresthesia, cognitive disorders such as memory loss, attention and speech.

Respiratory, thoracic and mediastinal disorders

  • Rare: dyspnoea.
  • Not known: respiratory depression.

Skin and subcutaneous tissue disorders

  • Rare: rash, pruritus, urticaria.

Musculoskeletal and connective tissue disorders

  • Not known: muscular hypotonia.

General disorders and administration site conditions

  • Uncommon: asthenia.

Immune system disorders

  • Very rare: angioedema, anaphylactic reactions.

Eye disorders

  • Not known: diplopia.

Gastrointestinal disorders

  • Common: dry mouth.
  • Uncommon nausea.
  • Not known: dyspepsia, vomiting.

Hepatobiliary disorders

  • Very rare: increased transaminases and or blood alkaline phosphatase may exceptionally perform a liver injury table.

Injury, poisoning and procedural complications

  • Rare: falls (especially in the elderly)

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the medicinal product.

Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers

4.9. Overdose  

The prognosis may be life threatening, especially in cases of Poly intoxication involving other central nervous system depressants (including alcohol).

In case of massive intake, the signs of overdose are manifested mainly by CNS depression which can range from drowsiness to coma, depending on the amount ingested.

Mild cases are manifested by signs of mental confusion, lethargy.

More serious cases are manifested by ataxia, hypotonia, hypotension, respiratory depression, exceptionally death.

In the event of oral overdose prior to 1 hour, induction of vomiting should be performed if the patient is conscious or, failing this, gastric lavage with protection of the airways.

After this time, administration of activated charcoal may reduce absorption.

Particular monitoring of cardio-respiratory functions in a specialized environment is recommended.

Hemodialysis is not useful in the treatment of overdose due to the large volume of distribution of zopiclone.

The administration of injectable flumazenil may be useful for the diagnosis and treatment of intentional or accidental overdose of benzodiazepines.

Antagonism by flumazenil of the effect of benzodiazepines may promote the onset of neurological disorders (convulsions), especially in patients with epilepsy.


5.1. Pharmacodynamic properties  

Pharmacotherapeutic group: hypnotics and sedatives, ATC code: N05CF01 – (N: central nervous system).

Zopiclone belongs to the chemical family of cyclopyrrolones and is related to the class of benzodiazepines.

It has a pharmacodynamic activity qualitatively similar to that of other compounds of this class:

  • Muscle relaxant,- anxiolytic,
  • Sedative,
  • Hypnotic,
  • Anticonvulsant,
  • Amnesic.

These effects are linked to a specific agonist action on a central receptor forming part of the “GABA-OMEGA macromolecular receptors” complex, also called BZ1 and BZ2 and modulating the opening of the chlorine channel.

In humans, zopiclone increases the duration and improves the quality of sleep, decreases the number of nocturnal awakenings and early awakenings.

These effects are associated with a characteristic electroencephalographic profile, different from that of benzodiazepines. Sleep recording studies have shown that zopiclone decreases stage I, prolongs stage II, respects or prolongs deep sleep stages (III and IV) and respects REM sleep.

5.2. Pharmacokinetic properties  


The absorption of zopiclone is rapid: maximum concentrations are reached within 1 h 30 to 2 hours and are approximately 30, 60 and 115 ng / ml respectively after administration of 3.75 mg, 7.5 mg and 15 mg. The bioavailability is of the order of 80%.

Absorption is not affected by the time of taking or repetition of doses or by gender.


Distribution of the product is very rapid from the vascular compartment. Plasma protein binding is low (approximately 45%) and unsaturable. The risk of drug interaction linked to protein defixation is very low.

Plasma decrease: between 3.75 mg and 15 mg, the decrease in plasma is independent of the dose.

The elimination half-life is approximately 5 hours.

Benzodiazepines and related molecules pass the blood-brain barrier as well as into the placenta and breast milk. In breast-feeding, the kinetics of zopiclone in breast milk are superimposed on that of plasma.

The estimated percentage of the dose ingested by the infant would not exceed 0.2% of the dose administered to the mother per 24 hours.


Zopiclone is extensively metabolized in the liver.

Among the metabolites, the 2 main ones are the N-oxide derivative (pharmacologically active in animals) and the N-demethylated derivative (pharmacologically inactive in animals).

Their apparent half-lives, evaluated from urine data, are 4.30 and 7.30, respectively, consistent with the fact that they did not show significant accumulation at repeated doses (15 mg) for 14 days. In animals, no enzyme induction has been demonstrated, even at high doses.


The low value of the renal clearance of unchanged zopiclone (on average 8.4 ml / min) compared to the plasma clearance (232 ml / min) indicates that the clearance of zopiclone is predominantly metabolic. The product is eliminated in the urine, approximately 80%, in the form of free metabolites (N-oxide and N-demethylated derivatives) and in the faeces , approximately 16%.

Populations at risk

Elderly: hepatic metabolism decreases slightly and the half-life has an average value of 7 hours. Despite this, various studies have not shown any accumulation of zopiclone in plasma during repeated administration.

Renal impairment : No accumulation of zopiclone or its metabolites has been detected after prolonged use. Zopiclone crosses the dialysis membrane.
Hemodialysis is not useful in the treatment of overdose due to the large volume of distribution of zopiclone.

Cirrhosis : the plasma clearance of zopiclone is markedly reduced by slowing down demethylation: the dosage should therefore be adjusted.

5.3. Preclinical safety data  

Not applicable.

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6.1. List of excipients  

Anhydrous lactose, anhydrous calcium hydrogen phosphate, corn starch, povidone K30, magnesium stearate.

Film coating: OPADRY BLANC Y-1-7000 (Hypromellose, titanium dioxide (E171), macrogol 400).

6.2. Incompatibilities  

Not applicable.

6.3. The duration of the conversation  

2 years

6.4. Special precautions for storage  

Store at a temperature less than  25 ° C.

6.5. Special precautions for disposal and handling  

No special requirements.


The duration of prescription of this medication cannot exceed 4 weeks

Therapeutic indications

Pharmacotherapeutic group : hypnotics and sedatives – ATC code: N05CF01 (N: central nervous system).

This drug belongs to a family of drugs related to benzodiazepines.

This medicine is used for the short-term treatment of insomnia in adults.

It acts:

  • By increasing the duration and improving the quality of sleep;
  • By reducing the number of times we wake up at night and the number of times we wake up too early.

In children, given the absence of data, the use of ZAPICLONE MYLAN7.5 mg film-coated tablet is not recommended.


Generic groups

This medication belongs to the following generic group (s):

  • ZOPICLONE 7.5 mg – IMOVANE 7.5 mg, film-coated tablet.

Composition of active substances

  • Tablet (Composition for one tablet)
    • > zopiclone  5 mg

Is Mylan a sleeping pill?

Zolpidem Mylan contains zolpidem, which belongs to a group of medicines called hypnotics. Zolpidem Mylan Tablets are sleeping pills, which work by acting on the brain to cause sleepiness.

This medicine may be used in adults for short-term treatment of insomnia which is severe, disabling or causing great distress.

How long does Zopiclone Mylan take to work?

You can start the combination pill at any time. If you start within 5 days after the start of your period, you’re protected from pregnancy right away

When should I take Zopiclone Mylan?

Normally , this medication is taken once a day, no more than 24 hours apart. When the 21 active pills run out, take the 7 reminder pills.

During the time of taking the reminder pills you should get your period. If you do not get your period for two consecutive months, consult your doctor








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