Sleepwel
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 |
|---|---|---|
| sleepwel 1 mg tablet | ৳ 2.01 | ৳ 20.10 |
| sleepwel 2 mg tablet | ৳ 3.02 | ৳ 30.19 |
Description
Overview of the medicine
Sleepwel (Zolpidem Tartrate) is a non-benzodiazepine hypnotic used for the short-term treatment of insomnia. It acts quickly to help initiate and maintain sleep.
Uses & Indications
Dosage
Adults
Recommended starting dose is 5 mg for women and 5 mg or 10 mg for men, taken orally once daily immediately before bedtime. Max 10 mg/day.
Elderly
Recommended starting dose is 5 mg immediately before bedtime.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. Use with caution in severe impairment.
How to Take
Administer orally immediately before bedtime. Do not take with or immediately after a meal as this may delay onset of action. Ensure at least 7-8 hours available for sleep.
Mechanism of Action
Zolpidem selectively binds to the omega-1 receptor (a subtype of the GABA-A receptor complex), potentiating GABAergic inhibition, which results in sedative, hypnotic, anxiolytic, and anticonvulsant effects.
Pharmacokinetics
Onset
15-30 minutes
Excretion
Metabolites are primarily excreted in urine (approx. 50%) and feces (approx. 33%).
Half life
Approximately 2.5-2.8 hours
Absorption
Rapidly absorbed from the gastrointestinal tract, peak plasma concentrations reached within 0.5-3 hours.
Metabolism
Extensive hepatic metabolism via CYP450 enzymes (mainly CYP3A4, CYP2C9, CYP1A2, CYP2D6)
Side Effects
Contraindications
- Hypersensitivity to zolpidem or any component of the formulation.
- Severe hepatic impairment.
- Sleep apnea syndrome.
- Myasthenia gravis.
Drug Interactions
CNS Depressants
Increased sedative effects with alcohol, other hypnotics, anxiolytics, opioids, tricyclic antidepressants.
CYP3A4 Inducers
Decreased zolpidem exposure (e.g., rifampicin, St. John's Wort).
CYP3A4 Inhibitors
Increased zolpidem exposure (e.g., ketoconazole, erythromycin).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include impaired consciousness ranging from somnolence to coma, cardiovascular and/or respiratory depression. Management involves general symptomatic and supportive measures, gastric lavage if appropriate, and monitoring vital signs. Flumazenil may be used as an antidote.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as it is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to zolpidem or any component of the formulation.
- Severe hepatic impairment.
- Sleep apnea syndrome.
- Myasthenia gravis.
Drug Interactions
CNS Depressants
Increased sedative effects with alcohol, other hypnotics, anxiolytics, opioids, tricyclic antidepressants.
CYP3A4 Inducers
Decreased zolpidem exposure (e.g., rifampicin, St. John's Wort).
CYP3A4 Inhibitors
Increased zolpidem exposure (e.g., ketoconazole, erythromycin).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms include impaired consciousness ranging from somnolence to coma, cardiovascular and/or respiratory depression. Management involves general symptomatic and supportive measures, gastric lavage if appropriate, and monitoring vital signs. Flumazenil may be used as an antidote.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as it is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Available in pharmacies nationwide
Approval Status
Approved by FDA, DGDA
Patent Status
Generic available, patent expired
Clinical Trials
Extensive clinical trials have demonstrated Zolpidem's efficacy in reducing sleep latency and improving sleep maintenance for short-term insomnia treatment.
Lab Monitoring
- No routine laboratory monitoring is typically required.
- Liver function tests may be considered in patients with hepatic impairment.
Doctor Notes
- Emphasize short-term use (typically 2-4 weeks).
- Advise patients on potential for dependence and withdrawal symptoms.
- Counsel on complex sleep behaviors and instruct to discontinue if they occur.
- Assess for underlying causes of insomnia.
Patient Guidelines
- Take exactly as prescribed.
- Do not take more than the recommended dose.
- Take immediately before going to bed, ensuring you have 7-8 hours for sleep.
- Avoid alcohol and other CNS depressants.
- Do not drive or operate machinery after taking this medicine.
- Do not stop taking abruptly without consulting your doctor.
Missed Dose Advice
If a dose is missed and you still have several hours available for sleep, you may take it. If it's almost time for your next dose or if you don't have enough time for a full night's sleep (7-8 hours), skip the missed dose and resume your regular schedule. Do not double the dose.
Driving Precautions
This medicine can cause drowsiness, dizziness, and impaired judgment. Do not drive or operate heavy machinery until you know how it affects you.
Lifestyle Advice
- Practice good sleep hygiene (e.g., regular sleep schedule, comfortable sleep environment, avoid caffeine/heavy meals before bed).
- Limit screen time before sleep.
- Engage in regular physical activity, but avoid close to bedtime.
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