Zolen
Generic Name
Zolpidem
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Zolpidem is a short-acting non-benzodiazepine hypnotic used for the short-term treatment of insomnia. It works by affecting chemicals in the brain that may be unbalanced in people with sleep problems.
Uses & Indications
Dosage
Adults
The recommended adult dose is 5 mg or 10 mg taken once daily immediately before bedtime with at least 7-8 hours remaining before planned awakening.
Elderly
A lower dose of 5 mg is recommended for elderly or debilitated patients due to increased sensitivity and slower elimination.
Renal_impairment
No dose adjustment is routinely required for mild to moderate renal impairment, but caution is advised in severe cases.
How to Take
Take orally, immediately before going to bed. Do not take with food or immediately after a meal, as this may delay the onset of action. Ensure you have at least 7-8 hours for sleep.
Mechanism of Action
Zolpidem selectively binds to the benzodiazepine omega-1 receptor (GABA-A receptor) on the alpha-1 subunit, leading to enhanced GABAergic inhibition and hypnotic effects. This action reduces sleep latency and increases total sleep time.
Pharmacokinetics
Onset
Onset of hypnotic effect within 15-30 minutes.
Excretion
Excreted mainly by the kidneys (approximately 60%) and in faeces (approximately 40%) as inactive metabolites.
Half life
Elimination half-life is approximately 2-3 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract, peak plasma concentration reached in 0.5 to 2.5 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4, CYP2C9, and CYP1A2, to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Zolpidem 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 sedative effect and risk of respiratory depression.
CYP3A4 inducers (e.g., Rifampicin, Carbamazepine)
May decrease Zolpidem plasma concentrations and efficacy.
CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Zolpidem plasma concentrations.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms range from somnolence to coma and possible fatal respiratory depression. Management involves general symptomatic and supportive measures, with gastric lavage and activated charcoal if appropriate. Flumazenil may be considered in severe cases.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Zolpidem is excreted in breast milk; therefore, use is not recommended during lactation.
Side Effects
Contraindications
- Hypersensitivity to Zolpidem 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 sedative effect and risk of respiratory depression.
CYP3A4 inducers (e.g., Rifampicin, Carbamazepine)
May decrease Zolpidem plasma concentrations and efficacy.
CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Zolpidem plasma concentrations.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms range from somnolence to coma and possible fatal respiratory depression. Management involves general symptomatic and supportive measures, with gastric lavage and activated charcoal if appropriate. Flumazenil may be considered in severe cases.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Zolpidem is excreted in breast milk; therefore, use is not recommended during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved
Patent Status
Expired
Clinical Trials
Extensive clinical trials have demonstrated Zolpidem's efficacy and safety for short-term insomnia treatment. Studies have focused on sleep latency, sleep duration, and wakefulness after sleep onset.
Lab Monitoring
- Routine lab monitoring is generally not required.
- Liver function tests may be considered in patients with hepatic impairment.
- Assess for signs of abuse or dependence during long-term use.
Doctor Notes
- Emphasize short-term use (2-4 weeks) due to risk of dependence and withdrawal.
- Assess for underlying causes of insomnia before initiating Zolpidem.
- Advise patients about potential complex sleep behaviors and instruct them to discontinue if these occur.
- Caution against abrupt discontinuation due to withdrawal symptoms.
Patient Guidelines
- Take Zolpidem exactly as prescribed by your doctor.
- Do not exceed the recommended dose.
- Take immediately before going to bed, and ensure you have at least 7-8 hours available for sleep.
- Avoid alcohol and other CNS depressants.
- Do not drive or operate heavy machinery after taking this medicine.
Missed Dose Advice
If you miss a dose, take it only if you can still get a full night's sleep (7-8 hours). Do not take a double dose to make up for a missed one.
Driving Precautions
Zolpidem can cause drowsiness, dizziness, and impaired judgment, which can affect your ability to drive or operate machinery. Do not drive or engage in activities requiring mental alertness after taking this medicine.
Lifestyle Advice
- Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment).
- Avoid caffeine and alcohol, especially in the evening.
- Engage in regular physical activity, but not too close to bedtime.
- Manage stress effectively.
- Limit daytime naps.
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