Zolium-XR
Generic Name
Zolpidem Extended-Release
Manufacturer
Example Pharmaceutical Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zolium xr 1 mg tablet | ৳ 4.00 | ৳ 40.00 |
Description
Overview of the medicine
Zolium-XR 1 mg Tablet contains Zolpidem Extended-Release, a sedative-hypnotic primarily used for the short-term treatment of insomnia, particularly for difficulties with both initiating and maintaining sleep. The extended-release formulation helps in sustained action.
Uses & Indications
Dosage
Adults
The usual recommended dose for Zolpidem Extended-Release is 6.25 mg or 12.5 mg once daily at bedtime. 1 mg is an exceptionally low dose for XR formulation and should only be used as directed by a physician for specific patient needs, likely as a starting or highly sensitive patient dose.
Elderly
For elderly or debilitated patients, a lower dose of 6.25 mg once daily at bedtime is generally recommended. A 1 mg dose, if prescribed, should be used with extreme caution and medical supervision.
Renal_impairment
No dosage adjustment is typically required for patients with mild to moderate renal impairment, but caution is advised. For severe renal impairment, use with extreme caution or avoid.
How to Take
Take Zolium-XR 1 mg orally once daily immediately before bedtime, on an empty stomach. Do not crush, chew, or divide the tablet as it is an extended-release formulation. Swallow whole with water.
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 sedative, hypnotic, anxiolytic, and anticonvulsant properties, primarily promoting sleep.
Pharmacokinetics
Onset
Approximately 30-60 minutes.
Excretion
Excreted primarily through the kidneys (approximately 60%) and feces (approximately 40%) as inactive metabolites.
Half life
Approximately 2-3 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract. Peak plasma concentration for XR formulation is reached within 1.5 to 4 hours.
Metabolism
Extensively metabolized in the liver, primarily via the cytochrome P450 enzymes (CYP3A4, CYP2C9, CYP1A2) to inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to Zolpidem or any inactive ingredients.
- Patients who have experienced complex sleep behaviors after taking Zolpidem.
- Severe hepatic impairment.
- Acute narrow-angle glaucoma.
Drug Interactions
Alcohol
Concurrent use with alcohol increases CNS depressant effects and impairment.
CYP3A4 Inducers (e.g., Rifampin, Carbamazepine, Phenytoin)
May decrease Zolpidem plasma levels, potentially reducing its efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)
May increase Zolpidem plasma levels, leading to enhanced effects and side effects.
Other CNS Depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants)
Additive CNS depressant effects, increasing risk of respiratory depression and sedation.
Storage
Store in a cool, dry place, below 30°C (86°F), away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of Zolpidem overdose include somnolence, coma, respiratory depression, and cardiovascular collapse. Management involves general symptomatic and supportive measures, including gastric lavage (if ingested recently), intravenous fluids, and maintaining a patent airway. Flumazenil may be considered in severe cases, but carries risks.
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 breast milk; therefore, caution should be exercised when Zolium-XR is administered to a nursing woman.
Side Effects
Contraindications
- Known hypersensitivity to Zolpidem or any inactive ingredients.
- Patients who have experienced complex sleep behaviors after taking Zolpidem.
- Severe hepatic impairment.
- Acute narrow-angle glaucoma.
Drug Interactions
Alcohol
Concurrent use with alcohol increases CNS depressant effects and impairment.
CYP3A4 Inducers (e.g., Rifampin, Carbamazepine, Phenytoin)
May decrease Zolpidem plasma levels, potentially reducing its efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)
May increase Zolpidem plasma levels, leading to enhanced effects and side effects.
Other CNS Depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants)
Additive CNS depressant effects, increasing risk of respiratory depression and sedation.
Storage
Store in a cool, dry place, below 30°C (86°F), away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of Zolpidem overdose include somnolence, coma, respiratory depression, and cardiovascular collapse. Management involves general symptomatic and supportive measures, including gastric lavage (if ingested recently), intravenous fluids, and maintaining a patent airway. Flumazenil may be considered in severe cases, but carries risks.
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 breast milk; therefore, caution should be exercised when Zolium-XR is administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture when stored under recommended conditions.
Availability
Pharmacies, hospitals
Approval Status
FDA Approved (for Zolpidem Extended-Release)
Patent Status
Generic available
Clinical Trials
Zolpidem Extended-Release has undergone extensive clinical trials demonstrating its efficacy and safety for the treatment of insomnia. Studies have shown significant improvements in sleep latency and sleep maintenance compared to placebo.
Lab Monitoring
- Routine laboratory monitoring is generally not required for patients taking Zolpidem. Liver function tests may be considered in patients with suspected or known hepatic impairment.
Doctor Notes
- Thoroughly assess patients for underlying causes of insomnia, including psychiatric and/or medical conditions, before initiating Zolpidem.
- Educate patients about the risks of complex sleep behaviors and the importance of taking the medication exactly as prescribed.
- Monitor for signs of dependence or misuse, especially in patients with a history of substance abuse.
Patient Guidelines
- Take Zolium-XR exactly as prescribed by your doctor, immediately before bedtime.
- Do not take more than one dose per night.
- Avoid alcohol and other CNS depressants while on this medication.
- Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms may occur.
- Report any unusual or complex sleep behaviors (e.g., sleep-driving, sleep-eating) to your doctor immediately.
Missed Dose Advice
If you miss a dose and remember it later in the night, only take it if you still have 7-8 hours available for sleep. If less time is available, skip the missed dose and take your next dose at the regular time. Do not double the dose to compensate.
Driving Precautions
Zolium-XR can cause drowsiness, dizziness, and impaired judgment. Do not drive, operate machinery, or engage in other activities requiring mental alertness until you know how this medicine affects you. These effects can be more pronounced the morning after use.
Lifestyle Advice
- Practice good sleep hygiene, including maintaining a regular sleep schedule, creating a dark and quiet sleep environment, and avoiding large meals or caffeine before bed.
- Regular physical activity can improve sleep, but avoid strenuous exercise close to bedtime.
- Manage stress through relaxation techniques or mindfulness.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Zolium-XR Brand
Other medicines available under the same brand name
