Zopilone (Generic)
Generic Name
Zopiclone 1 mg tablet
Manufacturer
Reputable Generic Manufacturer
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zopilone 1 mg tablet | ৳ 2.00 | ৳ 20.00 |
Description
Overview of the medicine
Zopiclone is a non-benzodiazepine hypnotic from the cyclopyrrolone family used for the short-term treatment of insomnia. The 1 mg strength is a very low dose, potentially for highly sensitive patients or to minimize side effects.
Uses & Indications
Dosage
Adults
The usual recommended dose for Zopiclone is 3.75 mg or 7.5 mg, taken once daily at bedtime. A 1 mg tablet would be considered a very low initial dose, potentially for highly sensitive individuals or as determined by a physician based on patient response, especially if aiming for minimal sedation.
Elderly
For elderly patients, a reduced starting dose is usually recommended, typically 3.75 mg. A 1 mg tablet may be suitable for initiation in very frail elderly patients, to be used with extreme caution.
Renal_impairment
Initial dose of 3.75 mg recommended. A 1 mg tablet could be considered if further dose reduction is clinically warranted.
Hepatic_impairment
Initial dose of 3.75 mg recommended. A 1 mg tablet could be considered if further dose reduction is clinically warranted.
How to Take
Take orally, once daily, immediately before bedtime. Do not take with food if rapid onset of action is desired. Swallow the tablet whole with water.
Mechanism of Action
Zopiclone acts on GABA-A receptors, increasing the affinity of GABA for its receptors, leading to increased chloride ion influx, hyperpolarization, and decreased neuronal excitability in the central nervous system, thus producing sedative, anxiolytic, anticonvulsant, and muscle relaxant effects.
Pharmacokinetics
Onset
Within 30-60 minutes after oral administration.
Excretion
Mainly via urine (approx. 80%) and feces (approx. 16%) as metabolites. Less than 5% excreted unchanged.
Half life
Approximately 3.5 to 6.5 hours; prolonged in elderly and patients with hepatic impairment.
Absorption
Rapidly absorbed from the gastrointestinal tract; peak plasma concentrations reached within 1.5 to 2 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4 and CYP2C8, to two main inactive metabolites (N-desmethylzopiclone and zopiclone N-oxide) and one active metabolite (6-N-demethylzopiclone) with short half-life.
Side Effects
Contraindications
- Hypersensitivity to zopiclone or any component of the formulation
- Myasthenia gravis
- Severe respiratory insufficiency
- Severe sleep apnea syndrome
- Severe hepatic impairment
Drug Interactions
Neuromuscular blockers
Potential for enhanced muscle relaxant effect.
CYP3A4 Inducers (e.g., rifampicin, carbamazepine, phenytoin)
May decrease zopiclone plasma concentrations, leading to reduced efficacy. Dose increase may be necessary.
CNS Depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants)
Increased risk of sedation, respiratory depression, and coma. Concomitant use should be avoided or used with extreme caution with reduced doses.
CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, grapefruit juice)
May increase zopiclone plasma concentrations, leading to enhanced effects. Dose reduction may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include varying degrees of CNS depression, from drowsiness to coma, and potentially respiratory depression. Management involves supportive care, gastric lavage/activated charcoal if recent ingestion, and monitoring of vital signs. Flumazenil may be considered in severe cases.
Pregnancy & Lactation
Zopiclone is not recommended during pregnancy, especially in the first and third trimesters, due to potential risks to the fetus (e.g., CNS depression, withdrawal symptoms in newborns). It is excreted in breast milk and therefore not recommended during lactation.
Side Effects
Contraindications
- Hypersensitivity to zopiclone or any component of the formulation
- Myasthenia gravis
- Severe respiratory insufficiency
- Severe sleep apnea syndrome
- Severe hepatic impairment
Drug Interactions
Neuromuscular blockers
Potential for enhanced muscle relaxant effect.
CYP3A4 Inducers (e.g., rifampicin, carbamazepine, phenytoin)
May decrease zopiclone plasma concentrations, leading to reduced efficacy. Dose increase may be necessary.
CNS Depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants)
Increased risk of sedation, respiratory depression, and coma. Concomitant use should be avoided or used with extreme caution with reduced doses.
CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, grapefruit juice)
May increase zopiclone plasma concentrations, leading to enhanced effects. Dose reduction may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include varying degrees of CNS depression, from drowsiness to coma, and potentially respiratory depression. Management involves supportive care, gastric lavage/activated charcoal if recent ingestion, and monitoring of vital signs. Flumazenil may be considered in severe cases.
Pregnancy & Lactation
Zopiclone is not recommended during pregnancy, especially in the first and third trimesters, due to potential risks to the fetus (e.g., CNS depression, withdrawal symptoms in newborns). It is excreted in breast milk and therefore not recommended during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date
Availability
Pharmacies
Approval Status
Approved (for Zopiclone)
Patent Status
Off-patent (Generic available)
Clinical Trials
Extensive clinical trials support the efficacy and safety of zopiclone for short-term insomnia treatment. Ongoing studies might explore long-term effects or use in specific populations.
Lab Monitoring
- Routine lab monitoring is generally not required for zopiclone use. However, liver function tests may be considered in patients with hepatic impairment.
Doctor Notes
- Emphasize short-term use (2-4 weeks maximum) to minimize dependence and withdrawal risks.
- Advise patients about potential residual sedation and impaired alertness the next day.
- Counsel on the importance of sleep hygiene in conjunction with medication.
Patient Guidelines
- Take exactly as prescribed by your doctor, usually just before going to bed.
- Do not take more than the recommended dose, and do not take for longer than 2-4 weeks without consulting your doctor.
- Avoid alcohol consumption while taking this medicine.
- Do not suddenly stop taking this medicine, especially after prolonged use, as withdrawal symptoms may occur.
Missed Dose Advice
If you miss a dose, only take it if you can still get a full 7-8 hours of sleep. If it's close to your usual wake-up time, skip the missed dose and resume your regular dosing schedule the next night. Do not double the dose.
Driving Precautions
Zopiclone can cause drowsiness, dizziness, and impaired motor skills, which can affect your ability to drive or operate machinery. Do not drive or engage in activities requiring mental alertness until you know how this medicine affects you.
Lifestyle Advice
- Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed).
- Limit screen time before sleep.
- Engage in regular physical activity, but avoid strenuous exercise close to bedtime.
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