Zopiclon Hexal

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Zopiclon Hexal

Method of action: Hypnotic

Treatment option: Insomnia

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Zopiclon Hexal

Property Description
Active ingredient Zopiclone
Form Oral film-coated tablets
Pharmacological class Hypnotic / Sedative (Z-drug)
General purpose Assistance with severe insomnia
Origin Synthetic

Zopiclon Hexal is a specific pharmaceutical preparation containing the active ingredient zopiclone, which belongs to the pharmacological class of Hypnotics and Sedatives for the management of severe sleep disturbances. It is commonly identified as a "Z-drug" due to its distinct, nonbenzodiazepine structure as a cyclopyrrolone. This medication is a prescription-only item, and its general purpose is to provide reliable, short-term aid for adults struggling with pronounced insomnia and symptoms of sleeplessness.


What Type of Medicine is Zopiclon Hexal and Its Core Identity?

Zopiclon Hexal is fundamentally a synthetic hypnotic agent, utilized for its effects in initiating and maintaining sleep. Though it functions similarly to older sedatives by promoting widespread central nervous system (CNS) calming, zopiclone is structurally unrelated to the benzodiazepines, establishing its identity as a separate class of sedative-hypnotics. For a patient experiencing insomnia, the primary role is to temporarily quiet the brain's overactivity, offering assistance with issues such as frequent nocturnal awakenings or the inability to fall asleep.

Zopiclone's Composition, Form, and Origin

The preparation consists of oral tablets, which are typically film-coated to facilitate ingestion via the oral route of administration. Zopiclone itself is a synthetic compound supplied in its racemic form, containing both the pharmacologically active and inactive enantiomers. As a single-active-ingredient product, the zopiclone substance is combined with a solid pharmaceutical base made up of various excipients, essential for creating the stable tablet structure.

Zopiclone is indicated for transient, situational, and chronic insomnia in adults. This medicine is used to manage different types of severe sleeplessness.

What is Zopiclone's General Purpose?

The general purpose of zopiclone is to reliably facilitate the necessary transition into and maintenance of a restful state by enhancing the brain's natural calming signals. This effect is achieved through its mechanism as a potentiator of gamma-aminobutyric acid (GABA), the brain’s primary inhibitory messenger. Z-drugs, including zopiclone, serve as a short-term treatment option for insomnia. The therapeutic intent is for short-duration use to help restore normal sleep patterns.

Regulatory References

  1. NICE technology appraisal guidance TA77

What side effects are possible with Zopiclon Hexal?

Possible side effects and safety information

Zopiclone's safety profile, as documented in regulatory sources, is defined by categorized adverse reactions and specific constraints related to patient status and duration of use. Adverse reactions are primarily grouped into Nervous System, Psychiatric, and Gastrointestinal Disorders.

Frequency-Classified Adverse Reactions

The most frequently reported effects are classified as Common and include dysgeusia (a bitter or metallic taste), drowsiness, dry mouth, and headache. Uncommon effects include nausea, fatigue (asthenia), agitation, and nightmares. Rare effects documented in the labeling include anterograde amnesia, confusion, and allergic skin reactions.

Serious Adverse Reactions and Safety Constraints

Official labeling describes rare but clinically significant adverse reactions, such as Complex Sleep Behaviors (including sleepwalking and sleep-driving), which may lead to injury. Severe hypersensitivity reactions, such as angioedema (swelling that may affect the airway), are also noted as rare but serious events. Respiratory depression is listed, particularly when used with other Central Nervous System (CNS) depressants.

Safety is linked to exposure duration: the risk of dependence and the development of tolerance (reduced effect) increases with prolonged use, typically beyond a few weeks. Rebound insomnia and withdrawal symptoms are associated with the abrupt cessation of therapy. Population-specific statements include an increased risk of falls and confusion in older adults, and zopiclone is generally contraindicated in patients with severe hepatic impairment.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory profile for Zopiclon Hexal overdose is defined by a spectrum of Central Nervous System (CNS) depression as documented in official prescribing information.

Documented Overdose Manifestations

Feature Official Regulatory Statement
Overdose Presentations Symptoms include drowsiness (somnolence), lethargy, confusion, ataxia (incoordination), and hypotonia (muscle weakness), progressing to coma
Physiological Systems The primary systems affected are the CNS, the respiratory system (risk of respiratory depression), and the cardiovascular system (risk of hypotension)
Increased Risk Severity is increased by concomitant illness or a debilitated state. The risk of severe symptoms, including fatal outcome, is significantly higher when co-ingested with other CNS depressants, notably alcohol and opioids

Emergency Actions Mandated by Regulators

When a Zopiclon Hexal overdose is suspected, immediate medical attention must be sought. Contact emergency services immediately if severe symptoms such as loss of consciousness, signs of coma, or respiratory depression are present. Management should consist of symptomatic and supportive treatment in an adequate clinical environment.

Attention is required for continuous monitoring of respiratory and cardiovascular functions. Regulatory labeling notes that Flumazenil may be a useful antidote for reversing sedative effects, but hemodialysis is documented as being of no value.

Therapeutic Uses of Zopiclon Hexal

What Zopiclon Hexal Treats: Main Uses and Benefits

The medication is considered relevant for symptomatic relief across certain periods of pronounced or severe insomnia in adults, particularly when patients experience episodes of significant sleep disturbance.

Zopiclon Hexal supports the easing of sleep onset difficulties, such as the delay in falling asleep, and contributes to a more continuous rest period by addressing frequent nocturnal awakenings and early morning waking. This is applicable in clinical contexts involving transient or situational insomnia where the sleep disturbance creates noticeable interference with daily stability. The medication is generally applied in contexts involving acute or temporary symptom patterns.

By assisting in the process of achieving adequate rest, it provides supportive symptomatic relief, which contributes to improved daytime concentration and supports the patient during periods of acute sleep loss.

“It is commonly applied in therapeutic contexts where sleep difficulties cluster into patterns that create a noticeable interference with daily stability.”

Quick Fact: Relief for Sleep Onset Difficulties and Nocturnal Awakenings

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility for Zopiclon Hexal

Regulatory documents define strict rules for who can and cannot use Zopiclon Hexal.

Category Official Regulatory Stance
Populations Allowed Adults aged 18 years and older.
Populations Contraindicated Patients with Myasthenia gravis, Respiratory failure, Severe sleep apnoea syndrome, or Severe hepatic insufficiency.
Age-Related Rule The medicine is contraindicated and should not be used in children and adolescents under 18 years of age, as safety and efficacy are not established in this group.
Pregnancy/Lactation Status Not recommended during pregnancy or lactation due to insufficient data and risk of infant exposure.

Eligibility-Related Restrictions

Use is restricted or requires caution in several populations based on official labeling:

  • Organ Impairment: Patients with impaired renal function or mild-to-moderate hepatic insufficiency are eligible but typically require special consideration. Severe hepatic insufficiency is an absolute contraindication.
  • Older Adults: Individuals aged mathbf65 years and older are an eligible but designated special population.
  • Risk History: Extreme caution is required for patients with a history of alcohol or drug abuse/dependence. The medicine is contraindicated if a patient has previously experienced complex sleep behaviors after taking any zopiclone-like drug.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Zopiclon Hexal is characterized by two main types of interactions: the enhancement of CNS depressant effects and alterations in the drug's metabolism.

Pharmacodynamic Interactions

Concomitant use of Zopiclon Hexal with alcohol is not recommended as it significantly enhances the sedative effect. Caution is required when combining Zopiclon Hexal with other Central Nervous System (CNS) depressants, which include antipsychotics, other hypnotics, anxiolytics, sedative antihistamines, and opioids. This combination carries a risk of increased sedation, respiratory depression, coma, and death; therefore, the dosage and duration of concomitant use with opioids must be limited.

Pharmacokinetic Interactions (CYP3A4)

Zopiclone is metabolized primarily by the CYP3A4 enzyme system. Medicines that inhibit this enzyme can increase the plasma concentration of zopiclone, potentially requiring a dose reduction. Explicitly listed CYP3A4 inhibitors include erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir. Conversely, medicines that induce CYP3A4 activity can decrease zopiclone plasma levels and its effectiveness. Official documents list CYP3A4 inducers such as rifampicin, carbamazepine, phenobarbital, phenytoin, and the herbal remedy St. John's wort.

Mechanism of Action

Zopiclon Hexal: How it Works

Zopiclon Hexal works by directly modulating the central nervous system (CNS) at a molecular level to potentiate the signaling of the inhibitory neurotransmitter gamma-aminobutyric acid ( GABA), leading to widespread neural suppression and sedation.


Potentiation of the GABA A Receptor

The drug's primary mechanism involves acting as a positive allosteric modulator at the GABA A receptor complex. This interaction enhances the frequency of the receptor's chloride ( Cl^-) ion channel opening, causing an increased influx of negative ions. This cellular change results in neuronal hyperpolarization (making the cell's electrical charge more negative) and reduced excitability.


Cascading CNS Inhibitory Effects

This cellular inhibition cascades through the GABAergic inhibitory pathway, causing a rapid shift in the balance of neural activity away from excitation and toward generalized CNS depression. The reduced neuronal firing rate, particularly in areas governing wakefulness, is associated with widespread suppression of neural activity in these regulating centers.


Modulation of Sleep Architecture

The systemic inhibition affects key sleep-regulating centers, manifesting as a change in the timing and duration of the sleep-wake cycle. The drug's mechanism leads to predictable changes in sleep architecture, often increasing the amount of Stage 2 NREM sleep while reducing REM sleep, which contributes to the overall profile of pharmacologically-induced sleep.

Dosage and Administration Information

How to Use Zopiclon Hexal: Administration Guidelines

Zopiclon Hexal is a medication for oral use only and must be administered according to a strict, short-term standardized therapeutic protocol. These instructions dictate the timing, dose limits, and total duration of use.


Dosing and Frequency

Feature Standard Instruction
Route of Administration Oral. The tablet must be swallowed whole and not crushed or chewed.
Standard Adult Dose The recommended dose for non-elderly adults is 7.5 mg, taken once nightly.
Maximum Daily Dose The total dose must not exceed 7.5 mg in a 24-hour period.
Timing & Frequency Must be taken as a single intake just before retiring for the night. The dose must not be re-administered during the same night.
Required Sleep Window Administration should only occur when a patient is able to ensure a full 7 to 8 hours of uninterrupted sleep.

Duration and Specific Populations

Treatment with zopiclone is intended to be as short as possible. The total duration must not exceed four weeks, which includes any required period of dose reduction.

Population Recommended Starting Dose
Older Adults (Geriatric) 3.75 mg nightly.
Renal or Hepatic Impairment Treatment should be initiated at 3.75 mg nightly.
Pediatric Use Not recommended for children and adolescents under 18 years, as efficacy and safety have not been established.

Discontinuation Protocol

When discontinuing use after a course of treatment, the dosage schedule should be gradually tapered off. If a nightly dose is forgotten, the instruction is to skip the missed dose and take the next dose at the usual time the following night.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Zopiclon Hexal

This section provides a factual overview of the types of scientific research conducted on zopiclone, describing what the studies examined and where limitations exist, without making claims about effectiveness or providing medical advice.


Evidence for Use in General and Primary Insomnia

The available evidence includes short-term Randomized Controlled Trials (RCTs) and subsequent analyses in Systematic Reviews, applied in research exploring how symptoms change over time in the general adult population. The discussion will focus on the study designs and the specific sleep parameters (such as time to fall asleep and total sleep duration) that researchers examined in the general adult population.

Findings describe patterns observed in how measures of the time to fall asleep and total sleep duration evolved over short defined time intervals. The evidence so far describes that the studies primarily tracked outcomes over short follow-up durations, typically spanning a few weeks.


Evidence in Specialized or Medically Complex Insomnia

Studies in these areas were conducted during periods of increased symptom activity and research examined how sleep changes related to conditions marked by functional limitations. The evidence base includes studies conducted when insomnia occurs alongside co-existing medical conditions or in populations facing advanced illnesses.

In these specialized studies, researchers evaluated outcomes reflecting daily functioning or activity level, in addition to the core sleep metrics. The resulting evidence was used to study short-term changes observed in these specific patient groups. However, the available data for certain comorbidity groups remain insufficient compared to the general insomnia population.


Research for Use in Older Adults

Zopiclone was evaluated in geriatric populations, typically those aged 65 and above. The research examined short-term symptom changes in older adults, which are relevant to episodic sleep patterns. The findings describe patterns observed in these studies, reporting how symptoms evolved in the observed older populations during the research period. However, reviewers of the evidence suggest that the certainty remains low for conclusions regarding long-term use in this sensitive group.


What is Still Uncertain About Zopiclon Hexal's Evidence

An analysis of the available research indicates several areas where knowledge remains incomplete or uncertain. The evidence quality varies across studies, particularly with older trials, where methodological quality has been cited as unclear. Furthermore, there is limited information for long-term outcomes and the durability of the observed short-term effects, as the primary trials did not track outcomes over many months or years. Comparative evidence is lacking in some areas. Research is ongoing to better characterize these remaining evidence gaps.

Key Studies & References

  1. Effectiveness of Non-Benzodiazepine Hypnotics in Treatment of Adult Insomnia: Meta-Analysis of Data Submitted to the FDA for Drug Approval
  2. Public Assessment Report Scientific discussion Zopiclone Jubilant 7.5 mg, film-coated tablets (zopiclone) NL/H/2914
  3. Appropriate and cost-effective prescribing of short acting hypnotics (Includes NICE guidance context)

Frequently Asked Questions (FAQ)

Common questions about Zopiclon Hexal (FAQ)

Q: What types of over-the-counter medicines or supplements can interact with Zopiclon Hexal?

Official documents list the herbal remedy St. John's wort as an interaction, as it may reduce the effectiveness of zopiclone. Official documents advise caution with other Central Nervous System (CNS) depressants, which may include sedative components found in some over-the-counter products.


Q: Is Zopiclon Hexal listed as having the potential for abuse in official documents?

Official documents address the potential for the development of abuse and physical or psychological dependence with this medicine. The risk is described as increasing with the dose and duration of treatment, and is higher for those with a history of substance abuse or psychiatric disorders.


Q: Does Zopiclon Hexal have any known interactions with grapefruit juice?

Official product information notes that grapefruit juice may act as a CYP3A4 inhibitor, which is associated with potentially increased concentrations of zopiclone in the blood.


Q: Can Zopiclon Hexal cause feelings of restlessness or agitation?

Restlessness and agitation have been reported as types of psychiatric or paradoxical reactions associated with the use of sedative/hypnotic agents. Official labeling describes these effects as being reported, particularly in older adults.


Q: Is Zopiclon Hexal meant to help a person fall asleep or stay asleep, or both?

Zopiclone’s documented effects include both assistance with sleep initiation (reducing the time to fall asleep) and sleep maintenance (reducing nocturnal awakenings).


Q: Does taking Zopiclon Hexal affect the effectiveness of birth control?

Official information indicates that zopiclone does not affect the effectiveness of hormonal contraception, including contraceptive pills.


Q: Is it a requirement to take Zopiclon Hexal with food?

The official instructions primarily focus on the timing—that the tablet should be swallowed whole just before retiring for the night. Regulatory information does not specify a requirement to take the medicine with food.


Q: Is Zopiclon Hexal known to interact with opioid pain relievers?

Co-administration of zopiclone with opioids is associated with an increased risk of severe effects such as enhanced sedation, respiratory depression, coma, and death. This is an interaction requiring careful assessment when used concomitantly.


Q: Does Zopiclon Hexal work for short-term sleep problems or long-term insomnia?

Zopiclone is indicated for transient, situational, and chronic insomnia in adults. However, use is designated for short-term treatment only, based on regulatory guidance.


Q: Can Zopiclon Hexal be taken for insomnia that is caused by anxiety?

While the drug's pharmacological properties are described as including anxiolytic (anxiety-reducing) actions, the official indication for use is limited to the short-term treatment of insomnia in adults.


Q: Are there any activities to avoid the day after taking Zopiclon Hexal?

Official warnings describe caution against performing tasks that require complete mental alertness or motor coordination, such as driving a car or operating machinery, for at least 12 hours after administration.


Q: How long does Zopiclon Hexal typically stay in the system?

The elimination half-life for zopiclone in non-impaired adults is documented to be approximately 5 hours, typically ranging from 3.8 to 6.5 hours. This is the measure that determines how quickly the body processes the medicine.


Q: What is the difference between Zopiclon Hexal and other 'Z-drugs'?

Zopiclone belongs to the group of medicines known as 'Z-drugs,' which share a common mechanism of action to induce sleep. The individual medicines within the class differ primarily in their chemical structure and pharmacokinetic profiles (e.g., how long they last).


Q: Can Zopiclon Hexal cause a headache the morning after taking it?

Official labeling lists headache as a common side effect. Furthermore, warnings advise caution and awareness of hangover effects which may occur the next day, which include residual symptoms.


Q: Can Zopiclon Hexal make a person's breathing slow down?

Precautions are stated for patients with compromised respiratory function. Regulatory information notes that hypnotics, including zopiclone, have the capacity to depress the respiratory drive (slow breathing), particularly when combined with other CNS depressants.


Q: Do other medications taken for mental health issues interact with Zopiclon Hexal?

Caution is required when combining zopiclone with other Central Nervous System (CNS) depressants. This group includes some medications used for mental health such as antidepressants, antipsychotics, and anxiolytics, due to an increased risk of sedation.


Q: Does the 'Hexal' part of the name indicate a generic or brand name difference?

The name Zopiclon refers to the active ingredient, which is the generic name. The addition of Hexal identifies a specific pharmaceutical company that manufactures and markets the generic product.


Q: Is there a risk of a serious allergic reaction to Zopiclon Hexal?

Official labeling notes the rare but serious risk of severe hypersensitivity reactions. This includes angioedema (swelling of the face, tongue, or throat), which may potentially affect a person's breathing.


Q: Does taking Zopiclon Hexal make insomnia worse in the long term?

Continuous long-term use is associated with an increased risk of dependence, tolerance, and adverse cognitive effects. Abrupt cessation of use is also associated with a temporary return of insomnia symptoms in an enhanced form, known as rebound insomnia.


Q: What are the signs of a person having low blood pressure as a result of Zopiclon Hexal?

In cases of overdose, potential signs documented include feeling dizzy, light-headed, or faint, which are associated with low blood pressure.


Q: Can taking Zopiclon Hexal cause nausea or vomiting?

Nausea is listed as a possible side effect in official documents. Vomiting has also been documented as a gastrointestinal disturbance associated with use.

How should Zopiclon Hexal be stored and disposed of?

Storage and Disposal Requirements

Official regulatory documents classify Zopiclon Hexal film-coated tablets as a product that does not require any special storage conditions concerning temperature or environment. The product has an official shelf-life of 3 years when kept in its original, unopened packaging.

Storage Classification Requirement
Child Safety Keep out of the sight and reach of children.
Environmental Protection Do not dispose of via wastewater or household waste.
Waste Handling Dispose of any unused medicine or waste material in accordance with local requirements.

Storage rules primarily ensure safety by mandating that the medicine is inaccessible to children. Disposal instructions require adherence to local pharmaceutical waste protocols, directing patients to discard the product responsibly rather than in general household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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