Zopilone
Generic Name
Zopilone 2 mg tablet
Manufacturer
Generic Pharmaceutical Company
Country
Multiple countries
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zopilone 2 mg tablet | ৳ 3.00 | ৳ 30.00 |
Description
Overview of the medicine
Zopilone 2 mg tablet is a nonbenzodiazepine hypnotic used for the short-term treatment of insomnia. It helps in initiating and maintaining sleep.
Uses & Indications
Dosage
Adults
The usual recommended dose is 3.75 mg or 7.5 mg, taken orally at bedtime. 2 mg may be used for initiation or in specific cases.
Elderly
A lower dose of 3.75 mg is recommended. The 2 mg strength may be suitable for highly sensitive elderly patients.
Renal_impairment
A reduced dose of 3.75 mg is recommended. Caution is advised.
How to Take
Take the tablet orally, usually just before going to bed. Do not exceed the prescribed dose or duration of treatment. Swallow whole with water, do not chew or crush.
Mechanism of Action
Zopilone binds to a specific site on the GABA-A receptor complex, potentiating the inhibitory effects of GABA. This results in central nervous system depression, leading to sedative, anxiolytic, and hypnotic effects.
Pharmacokinetics
Onset
Typically within 30 minutes.
Excretion
Approximately 50% excreted in urine and 30% in feces, mainly as metabolites.
Half life
Approximately 3.5-6.5 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract; peak plasma concentration reached within 1-2 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4 and CYP2C8, to active and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to zopilone or any excipients.
- Myasthenia gravis.
- Severe respiratory insufficiency.
- Severe sleep apnea syndrome.
- Severe hepatic insufficiency.
Drug Interactions
Alcohol
Increases the sedative effect of zopilone. Avoid concomitant use.
CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin, ritonavir)
May increase zopilone plasma levels, leading to increased sedative effects. Dose reduction may be necessary.
CNS Depressants (e.g., benzodiazepines, opioids, antipsychotics)
Potentiate the central depressant effect. Concomitant use should be with caution and reduced dosage.
CYP3A4 Inducers (e.g., rifampicin, carbamazepine, phenobarbital)
May decrease zopilone plasma levels, potentially reducing its efficacy.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, lethargy, ataxia, and potentially respiratory depression and coma in severe cases. Management involves supportive care, gastric lavage if recent ingestion, and careful consideration of flumazenil as an antidote, which may precipitate withdrawal symptoms.
Pregnancy & Lactation
Zopilone is not recommended during pregnancy, especially in the first trimester, due to potential risks to the fetus. It is excreted in breast milk and should be avoided during lactation. Consult your doctor.
Side Effects
Contraindications
- Hypersensitivity to zopilone or any excipients.
- Myasthenia gravis.
- Severe respiratory insufficiency.
- Severe sleep apnea syndrome.
- Severe hepatic insufficiency.
Drug Interactions
Alcohol
Increases the sedative effect of zopilone. Avoid concomitant use.
CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin, ritonavir)
May increase zopilone plasma levels, leading to increased sedative effects. Dose reduction may be necessary.
CNS Depressants (e.g., benzodiazepines, opioids, antipsychotics)
Potentiate the central depressant effect. Concomitant use should be with caution and reduced dosage.
CYP3A4 Inducers (e.g., rifampicin, carbamazepine, phenobarbital)
May decrease zopilone plasma levels, potentially reducing its efficacy.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, lethargy, ataxia, and potentially respiratory depression and coma in severe cases. Management involves supportive care, gastric lavage if recent ingestion, and careful consideration of flumazenil as an antidote, which may precipitate withdrawal symptoms.
Pregnancy & Lactation
Zopilone is not recommended during pregnancy, especially in the first trimester, due to potential risks to the fetus. It is excreted in breast milk and should be avoided during lactation. Consult your doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture.
Availability
Available in pharmacies worldwide
Approval Status
Approved globally for the short-term treatment of insomnia
Patent Status
Expired
Clinical Trials
Extensive clinical trials have demonstrated zopilone's efficacy in reducing sleep latency and improving sleep maintenance for short-term treatment of insomnia.
Lab Monitoring
- No routine lab monitoring is required for healthy individuals.
- Liver function tests may be considered in patients with severe hepatic impairment.
Doctor Notes
- Emphasize short-term use (2-4 weeks) to minimize dependence and withdrawal risks.
- Advise patients on gradual dose tapering when discontinuing, especially after prolonged use.
- Counsel patients on potential complex sleep behaviors and the importance of avoiding alcohol and other CNS depressants.
- Caution in elderly patients due to increased risk of falls and cognitive side effects; consider lower starting doses.
Patient Guidelines
- Take exactly as prescribed by your doctor, usually just before bedtime.
- Do not take more than the prescribed dose or for longer than recommended (typically 2-4 weeks).
- Avoid alcohol and other CNS depressants while taking this medicine.
- Do not stop taking the medicine suddenly, especially after prolonged use, as withdrawal symptoms may occur. Consult your doctor for gradual dose reduction.
- This medicine may cause drowsiness and affect your ability to drive or operate machinery. Avoid such activities until you know how it affects you.
Missed Dose Advice
If you miss a dose, do not take it if it is not your usual bedtime. Do not take a double dose to make up for a forgotten dose. Simply take the next dose at the usual time.
Driving Precautions
Zopilone can cause drowsiness, dizziness, and impaired coordination, which may significantly impair your ability to drive or operate machinery. Do not drive or engage in hazardous activities until you are certain that the medicine does not adversely affect your performance.
Lifestyle Advice
- Practice good sleep hygiene (consistent sleep schedule, comfortable environment).
- Avoid caffeine and heavy meals before bedtime.
- Engage in regular physical activity, but not close to bedtime.
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