Slipam
Generic Name
Sliptam Tartrate
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
slipam 15 mg capsule | ৳ 5.00 | ৳ 30.00 |
Description
Overview of the medicine
Slipam 15 mg Capsule is a non-benzodiazepine hypnotic used for the short-term treatment of insomnia, particularly for difficulties with sleep initiation.
Uses & Indications
Dosage
Adults
The usual recommended dose is 15 mg taken orally once daily, immediately before bedtime. Do not exceed 15 mg per day.
Elderly
A lower starting dose of 7.5 mg (if available) may be considered, or 15 mg with careful monitoring, due to increased sensitivity and potential for adverse effects.
Renal_impairment
No dosage adjustment is generally required for mild to moderate renal impairment, but caution is advised. For severe impairment, consider a lower dose.
How to Take
Take orally, immediately before going to bed. It is recommended to take it on an empty stomach for faster absorption and onset of action. Do not take with food or immediately after a meal.
Mechanism of Action
Slipam selectively binds to the benzodiazepine 1 (BZ1) receptor on the GABA-A receptor complex, enhancing GABAergic inhibitory neurotransmission. This leads to sedative, hypnotic, anxiolytic, anticonvulsant, and muscle relaxant effects.
Pharmacokinetics
Onset
Within 15-30 minutes.
Excretion
Mainly excreted in urine as inactive metabolites (approximately 60%) and in feces (approximately 30%).
Half life
Approximately 2 to 3 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract; peak plasma concentrations occur within 0.5 to 2 hours.
Metabolism
Extensively metabolized in the liver, primarily via cytochrome P450 enzymes (CYP3A4 and CYP2C9), to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Sliptam Tartrate or any component of the formulation.
- Severe hepatic impairment.
- Sleep apnea syndrome.
- Myasthenia gravis.
- Severe acute or chronic respiratory insufficiency.
Drug Interactions
Alcohol and other CNS Depressants
Increased risk of drowsiness, respiratory depression, and impaired psychomotor performance. Avoid concomitant use.
CYP3A4 Inducers (e.g., Rifampicin, Carbamazepine)
May decrease Sliptam exposure, leading to reduced efficacy. Dose increase may be necessary.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Sliptam exposure, leading to enhanced effects. Dose reduction may be necessary.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically include drowsiness, confusion, impaired coordination, flaccid muscles, hypotension, respiratory depression, and coma. Treatment is supportive, including gastric lavage if recent ingestion, and monitoring vital signs. Flumazenil may be considered in severe cases.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless the benefits outweigh the risks. Sliptam is excreted in breast milk; therefore, it is not recommended for use by nursing mothers.
Side Effects
Contraindications
- Hypersensitivity to Sliptam Tartrate or any component of the formulation.
- Severe hepatic impairment.
- Sleep apnea syndrome.
- Myasthenia gravis.
- Severe acute or chronic respiratory insufficiency.
Drug Interactions
Alcohol and other CNS Depressants
Increased risk of drowsiness, respiratory depression, and impaired psychomotor performance. Avoid concomitant use.
CYP3A4 Inducers (e.g., Rifampicin, Carbamazepine)
May decrease Sliptam exposure, leading to reduced efficacy. Dose increase may be necessary.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Sliptam exposure, leading to enhanced effects. Dose reduction may be necessary.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose typically include drowsiness, confusion, impaired coordination, flaccid muscles, hypotension, respiratory depression, and coma. Treatment is supportive, including gastric lavage if recent ingestion, and monitoring vital signs. Flumazenil may be considered in severe cases.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless the benefits outweigh the risks. Sliptam is excreted in breast milk; therefore, it is not recommended for use by nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available
Clinical Trials
Sliptam has undergone extensive clinical trials demonstrating its efficacy and safety in the short-term treatment of insomnia. Key studies focused on sleep latency, total sleep time, and wake after sleep onset.
Lab Monitoring
- Regular monitoring of liver function tests may be considered in patients with hepatic impairment.
- Renal function monitoring in severe renal impairment.
Doctor Notes
- Emphasize short-term use (2-4 weeks). Assess patient for risk factors of abuse/dependence.
- Counsel patients on potential for complex sleep behaviors (e.g., sleep-driving) and the importance of reporting such events.
- Consider lower doses in elderly and patients with hepatic impairment.
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.
- Avoid alcohol and other CNS depressants while taking this medicine.
- Do not stop taking this medicine abruptly without consulting your doctor, as withdrawal symptoms may occur.
- Ensure you have 7-8 hours available for sleep after taking Slipam.
Missed Dose Advice
If a dose is missed, take it only if you can still get a full night's sleep (7-8 hours) before you need to be active again. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause drowsiness, dizziness, and impaired judgment. Do not drive or operate heavy machinery after taking Slipam until you know how it affects you and you are fully awake.
Lifestyle Advice
- Practice good sleep hygiene (e.g., regular sleep schedule, dark quiet room, avoid caffeine before bed).
- Incorporate relaxation techniques or stress management strategies.
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