Dormitol
Generic Name
Zolpinetine
Manufacturer
PharmaCo Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
dormitol 75 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Dormitol 75 mg Tablet contains Zolpinetine, a non-benzodiazepine hypnotic agent used for the short-term treatment of insomnia. It helps in initiating and maintaining sleep, improving sleep quality.
Uses & Indications
Dosage
Adults
75 mg once daily immediately before bedtime. Do not exceed 75 mg per day.
Elderly
A reduced dose of 37.5 mg once daily immediately before bedtime may be considered due to increased sensitivity and slower elimination. Maximum 75 mg if clinically necessary.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. Use with caution in severe renal impairment; a reduced dose may be necessary.
How to Take
Take orally immediately before going to bed. Do not take with food or immediately after a heavy meal as it may delay onset of action. Swallow the tablet whole; do not crush, chew, or break.
Mechanism of Action
Zolpinetine selectively binds to GABA-A receptor complexes containing the α1 subunit, enhancing GABAergic neurotransmission. This leads to sedative, hypnotic, anxiolytic, anticonvulsant, and muscle relaxant properties, primarily promoting sleep.
Pharmacokinetics
Onset
Within 30 minutes
Excretion
Mainly excreted in urine (approximately 60%) and feces (approximately 40%) as metabolites.
Half life
3-5 hours
Absorption
Rapidly absorbed from the gastrointestinal tract; peak plasma concentrations reached within 1-2 hours.
Metabolism
Extensively metabolized in the liver, primarily via CYP3A4 and CYP2C9, into inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Zolpinetine or any component of the formulation.
- Severe hepatic impairment.
- Severe respiratory insufficiency.
- Sleep apnea syndrome.
- Myasthenia gravis.
Drug Interactions
Alcohol and other CNS depressants
Increased sedative effect and potential for respiratory depression.
CYP3A4 inducers (e.g., rifampicin)
May decrease Zolpinetine levels, reducing efficacy.
CYP3A4 inhibitors (e.g., ketoconazole)
May increase Zolpinetine levels, potentially leading to increased adverse effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, flaccid muscles, hypotension, and respiratory depression. Treatment is primarily symptomatic and supportive; gastric lavage or activated charcoal may be considered in acute cases. Flumazenil may be considered in severe cases but should be used with caution.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as Zolpinetine may be excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Patent Pending
Clinical Trials
Phase III clinical trials demonstrated significant improvement in sleep latency and total sleep time compared to placebo in adults with chronic insomnia.
Lab Monitoring
- Liver function tests (baseline and periodically, especially in patients with hepatic impairment).
Doctor Notes
- Educate patients about the short-term nature of treatment.
- Monitor for signs of complex sleep behaviors.
- Assess for underlying causes of insomnia before prescribing.
Patient Guidelines
- Take Dormitol only when you are able to get a full night's sleep (7-8 hours).
- Do not take more than the prescribed dose.
- Avoid alcohol while taking this medicine.
- Do not stop suddenly after prolonged use; consult your doctor.
Missed Dose Advice
If a dose is missed and you still have several hours of sleep remaining, you may take the missed dose. However, if it's close to your usual waking time, skip the missed dose and resume your regular schedule. Do not double the dose.
Driving Precautions
Dormitol can cause drowsiness, dizziness, and impaired motor skills. Do not drive or operate machinery until you know how this medicine affects you.
Lifestyle Advice
- Practice good sleep hygiene (e.g., maintain a regular sleep schedule, create a comfortable sleep environment, avoid caffeine and heavy meals before bedtime).
- Engage in regular physical activity, but avoid strenuous exercise close to bedtime.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.