Zofen-TS
Generic Name
Zopiclone
Manufacturer
Local Pharmaceutical Company
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zofen ts 15 mg tablet | ৳ 7.20 | ৳ 72.00 |
Description
Overview of the medicine
Zopiclone is a non-benzodiazepine hypnotic used for the short-term treatment of insomnia. It helps in falling asleep faster and reducing nighttime awakenings.
Uses & Indications
Dosage
Adults
Usually 7.5 mg orally at bedtime. In severe cases, 15 mg may be used.
Elderly
3.75 mg orally at bedtime, may be increased to 7.5 mg if necessary.
Renal_impairment
Initial dose 3.75 mg at bedtime.
How to Take
Administer orally, usually just before bedtime, with water. Do not take with food or immediately after a heavy meal.
Mechanism of Action
Zopiclone binds to the benzodiazepine receptor site on the GABA-A receptor complex, enhancing the inhibitory effects of GABA. This leads to sedative, hypnotic, anxiolytic, anticonvulsant, and muscle relaxant properties.
Pharmacokinetics
Onset
Approximately 30 minutes.
Excretion
Primarily excreted in urine (approximately 80%) and feces (approximately 16%) as metabolites.
Half life
3.5 to 6.5 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4 and CYP2C8, to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to zopiclone or any excipients.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
- Sleep apnea syndrome.
- Myasthenia gravis.
Drug Interactions
CYP3A4 inducers (e.g., rifampicin, carbamazepine)
May decrease zopiclone plasma levels, reducing its effects.
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin)
May increase zopiclone plasma levels, enhancing its effects.
CNS depressants (e.g., alcohol, benzodiazepines, opioids)
Increased CNS depression, respiratory depression.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, lethargy, ataxia, hypotension, respiratory depression, and coma. Treatment is symptomatic and supportive, including gastric lavage and activated charcoal. Flumazenil may be used in severe cases.
Pregnancy & Lactation
Not recommended during pregnancy (especially third trimester) due to potential for fetal CNS depression and withdrawal symptoms in the neonate. Avoid during lactation as it passes into breast milk.
Side Effects
Contraindications
- Hypersensitivity to zopiclone or any excipients.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
- Sleep apnea syndrome.
- Myasthenia gravis.
Drug Interactions
CYP3A4 inducers (e.g., rifampicin, carbamazepine)
May decrease zopiclone plasma levels, reducing its effects.
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin)
May increase zopiclone plasma levels, enhancing its effects.
CNS depressants (e.g., alcohol, benzodiazepines, opioids)
Increased CNS depression, respiratory depression.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, lethargy, ataxia, hypotension, respiratory depression, and coma. Treatment is symptomatic and supportive, including gastric lavage and activated charcoal. Flumazenil may be used in severe cases.
Pregnancy & Lactation
Not recommended during pregnancy (especially third trimester) due to potential for fetal CNS depression and withdrawal symptoms in the neonate. Avoid during lactation as it passes into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date
Availability
Pharmacies
Approval Status
Approved by regulatory bodies (e.g., DGDA)
Patent Status
Generic available
Clinical Trials
Extensively studied for efficacy and safety in short-term insomnia treatment.
Lab Monitoring
- Not routinely required.
- Liver and kidney function tests may be considered in patients with hepatic or renal impairment.
Doctor Notes
- Advise patients on the importance of short-term use and potential for dependence.
- Caution against concomitant use with alcohol or other CNS depressants.
- Assess for underlying causes of insomnia before prescribing.
Patient Guidelines
- Take exactly as prescribed, usually just before bedtime.
- Do not take more than the recommended dose or for longer than prescribed.
- Avoid alcohol and other CNS depressants.
- Report any unusual sleep behaviors to your doctor.
- Do not stop taking abruptly without consulting a doctor, especially if used long-term.
Missed Dose Advice
If a dose is missed and it's not close to the next scheduled dose, skip the missed dose and continue with the next scheduled dose. Do not double the dose. Only take if you can get a full night's sleep (7-8 hours).
Driving Precautions
May cause drowsiness, dizziness, and impaired motor skills. Avoid driving or operating heavy machinery after taking this medicine and until you are sure of its effects. The morning after ingestion, caution is advised.
Lifestyle Advice
- Establish good sleep hygiene practices (regular sleep schedule, comfortable environment, avoid caffeine/heavy meals before bed).
- Avoid driving or operating machinery until you know how the medicine affects you.
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Global Brand Names
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