Zopiclone Tablets 20mg Technical Specification:
| Product Name: | Zopiclone Tablets 20mg |
| Brand Name: | Sliprex Fast |
| Strength: | 7.5mg, 10mg, 20mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Sedative-hypnotics |
| Indication: | Zopiclone is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Preserve in tight container. Keep in a cool & dry place. Protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Zopiclone Tablets 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Zopiclone Tablets 20mg
Each Film-coated tablet contains:
Zopiclone BP……….……20mg
Excipients………………. q. s
Colour: Titanium dioxide USP
THERAPEUTIC INDICATIONS:
Zopiclone is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class and is indicated for the short-term treatment of insomnia.
Zopiclone is a type of sleeping pill that can be taken to treat bad bouts of insomnia. It helps you fall asleep more quickly, and also helps stop you waking up during the night.
**Long term continuous use is not recommended.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Patients who take Sliprex Fast and other medicines to help them sleep may experience decreased ability to be alert the day after taking the medicine, even if they feel fully awake. This can cause next-day impairment of driving or other activities that require full mental alertness.
*Treat bad bouts of insomnia. It helps you fall asleep more quickly.
Read enclosed leaflet before use.
Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
Warning: In the elderly and/or debilitated patient an initial dose of 3.75mg is recommended. The dose maybe increased to a maximum of 7.5mg.
Prolong use of hypnotics is not recommended especially in the elderly.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F). Preserve in tight container. Keep in a cool & dry place. Protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Why Taj Pharmaceuticals?
Experience a legacy of excellence in pharmaceuticals with Taj Pharma’s Zopiclone Tablets. Our commitment to your well-being extends to your sleep quality. Taj Pharma’s Zopiclone Tablets are meticulously formulated to provide effective relief from insomnia and sleep disturbances, helping you enjoy rejuvenating nights and productive days. At Taj Pharma, quality is our cornerstone. Our state-of-the-art manufacturing facilities and stringent quality control measures ensure that every Zopiclone Tablet meets the highest industry standards. We prioritize your safety and peace of mind, making us the preferred choice for those seeking a trusted solution for sleep disorders.
With Taj Pharma, you’re not just choosing a medication; you’re choosing a partner in your journey to better health. Learn more about the benefits, dosage, and usage guidelines of Zopiclone Tablets by Taj Pharma and regain control over your sleep patterns. Taj Pharma’s dedication to quality and patient well-being, making it clear why they are a trusted choice for Zopiclone Tablets. It emphasizes the effectiveness of the medication and its role in promoting restful sleep, appealing to users looking for a reliable solution for insomnia and sleep disturbances.
What is Zopiclone Tablets and its use?
Zopiclone Tablets are a medication primarily prescribed to treat insomnia, a common sleep disorder characterized by difficulty falling asleep, staying asleep, or experiencing restorative sleep. Zopiclone is a sedative-hypnotic medication that helps individuals with insomnia initiate and maintain sleep, leading to improved sleep quality and duration.
Use:
- Treatment of Insomnia: Zopiclone Tablets are primarily used to address insomnia, a condition where individuals have trouble falling asleep or staying asleep. They are classified as a non-benzodiazepine hypnotic or sedative-hypnotic medication.
- Mechanism of Action: Zopiclone works by enhancing the activity of gamma-aminobutyric acid (GABA), a neurotransmitter in the brain that has a calming and sedative effect. By increasing GABA’s effects, Zopiclone promotes relaxation, reduces anxiety, and induces sleep.
- Dosage: The dosage of Zopiclone Tablets should be determined by a healthcare provider based on an individual’s specific needs and response to the medication. It is typically taken shortly before bedtime, as directed.
- Duration of Use: Zopiclone is generally intended for short-term use to address acute episodes of insomnia. Prolonged use can lead to tolerance, dependence, and reduced effectiveness. Therefore, it is essential to use Zopiclone Tablets under medical supervision and for the prescribed duration.
- Side Effects: Like all medications, Zopiclone Tablets may have side effects. Common side effects may include dizziness, dry mouth, metallic taste, headache, and daytime drowsiness. Less common but more severe side effects can occur, and any unusual or severe symptoms should be reported to a healthcare provider.
- Precautions: Before using Zopiclone Tablets, individuals should inform their healthcare provider about their medical history, existing medications (including over-the-counter and herbal supplements), and any allergies. This information helps assess the appropriateness of Zopiclone and potential drug interactions.
- Dependency and Withdrawal: Zopiclone has the potential for dependence and withdrawal symptoms when used for an extended period or in higher-than-prescribed doses. It’s crucial to follow the prescribed treatment plan and not abruptly stop the medication without medical guidance.
- Special Populations: Zopiclone may have different dosing considerations for certain populations, such as older adults or individuals with liver or kidney impairments. Healthcare providers will consider these factors when prescribing the medication.
- Lifestyle Considerations: While using Zopiclone, individuals should avoid alcohol and activities requiring alertness, such as driving or operating heavy machinery, as the medication can cause drowsiness and impaired coordination.
How does Zopiclone Tablets work?
Zopiclone Tablets work primarily as a sedative-hypnotic medication to help individuals with insomnia initiate and maintain sleep. The medication’s mechanism of action involves enhancing the activity of gamma-aminobutyric acid (GABA), a neurotransmitter in the brain that plays a key role in promoting relaxation, reducing anxiety, and inducing sleep.
Here’s a more detailed explanation of how Zopiclone Tablets work:
- GABA Function: Gamma-aminobutyric acid (GABA) is an inhibitory neurotransmitter in the central nervous system. It functions to calm and slow down neural activity in the brain, creating a sense of relaxation and drowsiness.
- GABA Receptors: GABA exerts its effects by binding to specific receptors on neurons, known as GABA receptors. When GABA binds to these receptors, it opens chloride channels in the neuron’s cell membrane, allowing negatively charged chloride ions to enter the neuron. This influx of chloride ions hyperpolarizes the neuron, making it less likely to transmit signals and reducing overall neural activity.
- Zopiclone’s Action: Zopiclone is classified as a non-benzodiazepine hypnotic, and it acts by enhancing the activity of GABA in the brain. Specifically, Zopiclone binds to a subtype of GABA receptors known as the GABA-A receptor complex. By doing so, it increases the affinity of GABA for its receptors and enhances the inhibitory effects of GABA on neural activity.
- Sedation and Sleep: The increased GABA activity and enhanced inhibition of neural signaling induced by Zopiclone result in sedation and the promotion of sleep. This helps individuals with insomnia fall asleep more quickly and stay asleep longer, ultimately improving sleep quality and duration.
- Duration of Action: Zopiclone is designed to have a relatively short duration of action, which means it helps individuals fall asleep but does not necessarily maintain a full night’s sleep. This feature is intended to reduce the risk of residual drowsiness the following day.
Benefits of Zopiclone Tablets:
- Improved Sleep Onset: Zopiclone helps individuals with insomnia fall asleep more quickly, reducing the time it takes to initiate sleep.
- Extended Sleep Duration: It can lead to longer periods of uninterrupted sleep, helping individuals stay asleep through the night.
- Enhanced Sleep Quality: Zopiclone can improve the overall quality of sleep, leading to a more restorative and refreshing sleep experience.
- Reduced Nighttime Awakenings: It helps decrease the frequency of waking up during the night, promoting a more continuous sleep pattern.
- Enhanced Daytime Functioning: By improving sleep quality, Zopiclone can lead to increased alertness, better concentration, and improved cognitive performance during the day.
- Reduced Anxiety and Tension: Zopiclone’s sedative effects can help calm anxious thoughts and reduce tension, facilitating the transition into sleep.
Common Side Effects of Zopiclone Tablets:
- Daytime Drowsiness: Some individuals may experience residual drowsiness or grogginess the morning after taking Zopiclone, especially if the medication is not taken within the recommended time frame before bedtime.
- Dry Mouth: Zopiclone can cause dryness in the mouth, which may be alleviated by staying hydrated and using sugar-free candies or gum.
- Metallic Taste: A metallic or bitter taste in the mouth is a common side effect of Zopiclone. This sensation is usually temporary and subsides over time.
- Dizziness or Lightheadedness: Some individuals may experience feelings of dizziness or lightheadedness, especially when standing up quickly. It’s advisable to stand up slowly to minimize this effect.
- Headache: Headaches can occur as a side effect of Zopiclone in some individuals. If severe or persistent, it should be reported to a healthcare provider.
- Nausea or Upset Stomach: Zopiclone can occasionally lead to feelings of nausea or mild stomach discomfort.
- Changes in Taste Perception: Some individuals may notice alterations in their sense of taste while taking Zopiclone.
- Unpleasant Dreams or Nightmares: Vivid or unusual dreams may occur as a side effect in some individuals.
Less Common Side Effects (but may be more serious):
- Memory Impairment or Confusion: In rare cases, Zopiclone may lead to memory problems or confusion, especially in older adults.
- Agitation or Restlessness: Some individuals may experience increased agitation or restlessness.
- Hallucinations or Delusions: While rare, Zopiclone can potentially lead to hallucinations or delusions.
- Dependency and Withdrawal Symptoms: Prolonged or high-dose use of Zopiclone can lead to dependence, and abrupt discontinuation can result in withdrawal symptoms. This is why it’s important to follow prescribed dosages and treatment plans.
It’s crucial to remember that not everyone will experience these side effects, and their severity can vary among individuals. If any side effects are severe, persistent, or concerning, it’s important to consult a healthcare provider. Additionally, individuals should not stop or adjust their medication without medical guidance.
Frequently asked questions (FAQs) about Zopiclone Tablets:
- What is Zopiclone, and how does it work?
Zopiclone is a medication used to treat insomnia. It works by enhancing the activity of GABA, a neurotransmitter that promotes relaxation and sleepiness in the brain.
- Is Zopiclone habitforming or addictive?
Zopiclone has the potential for dependence and addiction if used for an extended period or in higherthanprescribed doses. It should be used as directed by a healthcare provider.
- How should I take Zopiclone Tablets?
Zopiclone is typically taken orally shortly before bedtime. It’s essential to follow the prescribed dosage and not exceed it.
- How quickly does Zopiclone work, and how long does its effect last?
Zopiclone usually works within 30 minutes to an hour after taking it. Its effects can last for around 6 to 8 hours, promoting sleep initiation and maintenance.
- Is it safe to drive or operate heavy machinery after taking Zopiclone?
Zopiclone can cause drowsiness and impaired coordination, making activities like driving or operating heavy machinery unsafe. It’s advisable to avoid such activities until the effects have worn off.
- Can Zopiclone be used longterm?
Zopiclone is generally intended for shortterm use to address acute episodes of insomnia. Longterm use should be avoided without careful medical supervision.
- Are there any interactions with other medications or substances?
Zopiclone can interact with other medications and substances, including alcohol. It’s essential to inform your healthcare provider about all the medications, supplements, and herbs you are taking to assess potential drug interactions.
- What should I do if I miss a dose of Zopiclone?
If you miss a dose, take it as soon as you remember, but only if you have enough time for a full night’s sleep. Do not double the dose to make up for a missed one.
- Can I drink alcohol while taking Zopiclone Tablets?
It is not advisable to consume alcohol while taking Zopiclone, as it can increase the risk of side effects and impair your coordination and judgment.
- Are there any specific precautions or considerations for using Zopiclone in older adults or individuals with medical conditions?
Zopiclone may have different dosing considerations for certain populations, such as older adults or individuals with liver or kidney impairments. Healthcare providers will assess these factors when prescribing the medication.
- Can I stop taking Zopiclone abruptly?
It is generally not recommended to stop taking Zopiclone abruptly, as it can lead to withdrawal symptoms. Any changes to your medication regimen should be discussed with a healthcare provider.
As Zopiclone Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Zopiclone Tablets product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Zopiclone Tablets Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Zopiclone Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Zopiclone Tablets 10mg
C. Zopiclone Tablets 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Zopiclone BP……….……7.5mg
Excipients………………. q. s
Colour: Titanium dioxide USP
B. Zopiclone Tablets 10mg
Each Film-coated tablet contains:
Zopiclone BP……….……10mg
Excipients…………….…. q. s
Colour: Sunset yellow FCF
C. Zopiclone Tablets 20mg
Each Film-coated tablet contains:
Zopiclone BP……….……20mg
Excipients………………. q. s
Colour: Iron oxide red
THERAPEUTIC INDICATIONS:
Zopiclone is a type of sleeping pill that can be taken to treat bad bouts of insomnia. It helps you fall asleep more quickly, and also helps stop you waking up during the night.
**Long term continuous use is not recommended.
CAUTION & WARNING:
Patients who take Sliprex Fast and other medicines to help them sleep may experience decreased ability to be alert the day after taking the medicine, even if they feel fully awake. This can cause next-day impairment of driving or other activities that require full mental alertness.
*Treat bad bouts of insomnia. It helps you fall asleep more quickly.
Read enclosed leaflet before use.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
WARNING: In the elderly and/or debilitated patient an initial dose of 3.75mg is recommended. The dose maybe increased to a maximum of 7.5mg.
Prolong use of hypnotics is not recommended especially in the elderly.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Preserve in tight container.
Keep in a cool & dry place.
Protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

