Zolium
Generic Name
Zolpidem Tartrate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zolium 05 mg tablet | ৳ 3.40 | ৳ 34.00 |
Description
Overview of the medicine
Zolpidem is a short-acting non-benzodiazepine hypnotic used for the short-term treatment of insomnia (difficulty falling asleep, maintaining sleep, or early morning awakening). It helps to induce and maintain sleep.
Uses & Indications
Dosage
Adults
The recommended initial dose is 5 mg for adults, taken orally once daily immediately before bedtime. The maximum dose is 10 mg once daily.
Elderly
The recommended initial dose is 5 mg for elderly patients, taken orally once daily immediately before bedtime.
Renal_impairment
No dosage adjustment is generally required for patients with mild to moderate renal impairment. For severe impairment, caution is advised.
Hepatic_impairment
The recommended initial dose is 5 mg for patients with hepatic impairment, taken orally once daily immediately before bedtime. Use with caution in severe hepatic impairment.
How to Take
Take Zolium 05 mg Tablet orally, immediately before bedtime, on an empty stomach. Do not take it with or immediately after a meal as this may delay its effects. Ensure you have at least 7-8 hours available for sleep after taking the tablet.
Mechanism of Action
Zolpidem selectively binds to the benzodiazepine omega-1 receptor subtype on the GABA-A receptor complex, enhancing the inhibitory effects of GABA. This results in central nervous system depression, leading to sedation and sleep induction.
Pharmacokinetics
Onset
Approximately 30 minutes.
Excretion
Primarily excreted in urine (approximately 65%) and feces (approximately 35%) as inactive metabolites.
Half life
2 to 3 hours (increased in elderly and those with hepatic impairment).
Absorption
Rapidly absorbed from the gastrointestinal tract; peak plasma concentrations reached within 0.5 to 3 hours.
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes (primarily CYP3A4, but also CYP2C9, CYP1A2, CYP2D6) to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to zolpidem or any component of the formulation.
- Severe hepatic insufficiency.
- Sleep apnea syndrome.
- Myasthenia gravis.
- Severe acute respiratory insufficiency.
Drug Interactions
Imipramine, Chlorpromazine
May have additive effects, increasing drowsiness.
CYP3A4 Inducers (e.g., rifampin, St. John's Wort)
May decrease zolpidem plasma concentrations, reducing its efficacy. Increased dosage of zolpidem may be necessary.
CNS Depressants (e.g., alcohol, opioids, other sedatives)
Increased risk of CNS depression, sedation, and respiratory depression. Concomitant use should be avoided or used with extreme caution.
CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice)
May increase zolpidem plasma concentrations, leading to enhanced sedative effects. Dosage reduction of zolpidem 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 impaired consciousness ranging from somnolence to coma, cardiovascular and/or respiratory depression. Management is symptomatic and supportive, including gastric lavage and intravenous fluids. Flumazenil, a benzodiazepine receptor antagonist, may be used but its value in non-benzodiazepine overdose is controversial.
Pregnancy & Lactation
Pregnancy Category C. Zolpidem should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk; therefore, caution should be exercised when zolpidem is administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to zolpidem or any component of the formulation.
- Severe hepatic insufficiency.
- Sleep apnea syndrome.
- Myasthenia gravis.
- Severe acute respiratory insufficiency.
Drug Interactions
Imipramine, Chlorpromazine
May have additive effects, increasing drowsiness.
CYP3A4 Inducers (e.g., rifampin, St. John's Wort)
May decrease zolpidem plasma concentrations, reducing its efficacy. Increased dosage of zolpidem may be necessary.
CNS Depressants (e.g., alcohol, opioids, other sedatives)
Increased risk of CNS depression, sedation, and respiratory depression. Concomitant use should be avoided or used with extreme caution.
CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice)
May increase zolpidem plasma concentrations, leading to enhanced sedative effects. Dosage reduction of zolpidem 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 impaired consciousness ranging from somnolence to coma, cardiovascular and/or respiratory depression. Management is symptomatic and supportive, including gastric lavage and intravenous fluids. Flumazenil, a benzodiazepine receptor antagonist, may be used but its value in non-benzodiazepine overdose is controversial.
Pregnancy & Lactation
Pregnancy Category C. Zolpidem should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk; therefore, caution should be exercised when zolpidem is administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Refer to the packaging for the exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved, DGDA Approved
Patent Status
Patent Expired (Generic Available)
Clinical Trials
Numerous clinical trials have demonstrated Zolpidem's efficacy in reducing sleep latency and improving sleep maintenance in adults with insomnia. Trials have also assessed its safety profile and potential for dependence with short-term and long-term use.
Lab Monitoring
- No routine laboratory monitoring is typically required for Zolpidem use. However, liver function tests may be considered in patients with pre-existing hepatic impairment.
Doctor Notes
- Educate patients on the proper use of Zolpidem, emphasizing short-term therapy.
- Counsel on the risks of complex sleep behaviors and instruct them to discontinue the drug if these occur.
- Assess for underlying causes of insomnia before initiating Zolpidem.
- Monitor for signs of dependence or withdrawal if used for extended periods.
Patient Guidelines
- Take exactly as prescribed, just before bedtime. Do not take more than the recommended dose.
- Ensure you have 7-8 hours of uninterrupted sleep after taking it.
- Avoid alcohol and other CNS depressants while taking Zolium.
- Do not drive or operate heavy machinery until you know how Zolium affects you.
- Report any unusual sleep behaviors (e.g., sleep-walking, driving) to your doctor immediately.
- Do not stop taking Zolium suddenly after prolonged use without consulting your doctor, as this may cause withdrawal symptoms.
Missed Dose Advice
If you miss a dose, do not take it unless you have enough time (7-8 hours) for a full night's sleep before you need to be active again. Do not take a double dose to make up for a missed one.
Driving Precautions
Zolpidem can cause drowsiness, dizziness, and decreased alertness. These effects can impair your ability to drive or operate heavy machinery. Do not drive or engage in activities requiring full mental alertness until you know how this medicine affects you.
Lifestyle Advice
- Practice good sleep hygiene (e.g., regular sleep schedule, comfortable sleep environment).
- Avoid caffeine and heavy meals close to bedtime.
- Engage in regular physical activity, but avoid strenuous exercise too close to bedtime.
- Create a relaxing bedtime routine to help prepare your body for sleep.
- Limit screen time (phones, tablets, computers) before bed.
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