Sleepwel
Generic Name
sleepwel-1-mg-tablet
Manufacturer
PharmaCo 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 |
Description
Overview of the medicine
Sleepwel 1 mg Tablet is a non-benzodiazepine hypnotic indicated for the short-term treatment of insomnia in adults. It works by affecting the brain's chemicals to produce a calming effect, helping to initiate and maintain sleep.
Uses & Indications
Dosage
Adults
1 mg orally once daily, immediately before bedtime. The maximum recommended dose is 1 mg per day.
Elderly
A lower starting dose of 0.5 mg (if available) may be considered. For 1 mg, use with caution and monitor for increased sensitivity.
Renal_impairment
No specific dose adjustment is typically required for mild to moderate renal impairment. Use with caution in severe renal impairment.
How to Take
Take Sleepwel 1 mg tablet orally, immediately before going to bed. It should be taken on an empty stomach to ensure faster absorption and onset of action. Do not take with or immediately after a meal.
Mechanism of Action
Sleepwel selectively binds to the GABA-A receptor complex at a site different from benzodiazepines, enhancing the inhibitory effects of GABA (gamma-aminobutyric acid). This leads to neuronal hyperpolarization, reducing neuronal excitability and promoting sleep.
Pharmacokinetics
Onset
Onset of action typically occurs within 15-30 minutes.
Excretion
Excreted mainly in the urine (approximately 60%) and feces (approximately 40%) as inactive metabolites.
Half life
Elimination half-life is approximately 2-3 hours, allowing for relatively rapid clearance.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached within 1-2 hours.
Metabolism
Extensively metabolized in the liver, primarily via cytochrome P450 enzymes (e.g., CYP3A4, CYP2C9) to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to the active substance or any excipients.
- Severe hepatic impairment.
- Severe respiratory insufficiency.
- Sleep apnea syndrome.
- Myasthenia gravis.
Drug Interactions
Alcohol and other CNS Depressants
Concurrent use may increase the risk of CNS depression (e.g., sedation, respiratory depression).
CYP3A4 Inducers (e.g., Rifampicin)
May decrease the plasma concentration of Sleepwel, potentially reducing its efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole)
May increase the plasma concentration of Sleepwel, potentially leading to enhanced sedative effects.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically involve impaired consciousness ranging from somnolence to coma, and potentially more serious symptoms like respiratory depression. Management involves general symptomatic and supportive measures. Flumazenil may be considered in severe cases, but caution is advised.
Pregnancy & Lactation
Not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. It is not known whether Sleepwel is excreted in human milk, so caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to the active substance or any excipients.
- Severe hepatic impairment.
- Severe respiratory insufficiency.
- Sleep apnea syndrome.
- Myasthenia gravis.
Drug Interactions
Alcohol and other CNS Depressants
Concurrent use may increase the risk of CNS depression (e.g., sedation, respiratory depression).
CYP3A4 Inducers (e.g., Rifampicin)
May decrease the plasma concentration of Sleepwel, potentially reducing its efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole)
May increase the plasma concentration of Sleepwel, potentially leading to enhanced sedative effects.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically involve impaired consciousness ranging from somnolence to coma, and potentially more serious symptoms like respiratory depression. Management involves general symptomatic and supportive measures. Flumazenil may be considered in severe cases, but caution is advised.
Pregnancy & Lactation
Not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. It is not known whether Sleepwel is excreted in human milk, so caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory bodies
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Sleepwel 1 mg for the short-term treatment of insomnia, showing significant improvement in sleep onset and duration compared to placebo.
Lab Monitoring
- Routine laboratory monitoring is not typically required for patients on Sleepwel 1 mg tablet.
Doctor Notes
- Emphasize short-term use (typically 2-4 weeks) to minimize dependence risk.
- Counsel patients on potential for complex sleep behaviors and the importance of immediately discontinuing if they occur.
- Assess for underlying causes of insomnia and implement non-pharmacological interventions where appropriate.
Patient Guidelines
- Take exactly as prescribed by your doctor, do not exceed the recommended dose.
- Do not take with alcohol or other CNS depressants.
- Do not take if you have less than 7-8 hours available for sleep.
- Inform your doctor if you experience any unusual behaviors or side effects.
Missed Dose Advice
If you miss a dose, take it only if you still have 7-8 hours available for sleep. If less than 7-8 hours remain before you need to be active, skip the missed dose and resume your regular dosing schedule.
Driving Precautions
Sleepwel 1 mg tablet may cause drowsiness, dizziness, or impaired motor skills. Do not drive, operate machinery, or engage in activities requiring mental alertness until you know how this medicine affects you.
Lifestyle Advice
- Practice good sleep hygiene (e.g., consistent bedtime, comfortable sleep environment).
- Avoid caffeine and heavy meals before bedtime.
- Engage in regular physical activity, but not close to bedtime.
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Global Brand Names
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