Description
Zolpidem Tablets (5mg / 10mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a premier manufacturer of Zolpidem Tablets in India. This sedative-hypnotic medication treats short-term insomnia. We produce high-purity film-coated tablets. Our facility adheres to strict WHO-GMP standards. Therefore, we guarantee product safety and consistency. Healthy Inc manages our global exports and controlled substance licensing.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Zolpidem Tablets | | Generic Name | Zolpidem Tartrate USP / BP / IP | | Strength | 5mg / 10mg | | Dosage Form | Film Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Sedative / Hypnotic (Z-drug) | | Shelf Life | 36 Months | | Packaging | 10×10 Blister / 10×14 Strip / Bulk Jar |
3. Manufacturing Zolpidem Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Since Zolpidem Tablets are potent sedatives, we use precise blending technology. This ensures exact content uniformity in every 5mg or 10mg dose. We also apply a specialized film coating. This protects the drug from light and ensures stability.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Zolpidem Tablets. Exporting sleep medications requires specific government permits. We are experienced in securing these permissions. Thus, we ensure your shipment complies with international narcotics laws.
4. Quality Assurance We test every batch rigorously.
Assay Verification: We use HPLC testing. This confirms the Zolpidem Tartrate content.
Dissolution: We test how the tablet releases the drug. Rapid release is critical for helping patients fall asleep quickly.
Impurities: We check for degradation products. This ensures the medicine remains safe throughout its shelf life.
5. Why Use Zolpidem Tablets? This drug is highly effective for sleep initiation.
Mechanism: It binds to GABA receptors in the brain. Consequently, it slows down brain activity.
Effect: It helps patients fall asleep rapidly. It is less likely to cause a “hangover” effect than older benzodiazepines.
Key Indications:
Short-term treatment of Insomnia.
Treatment of difficulties with sleep initiation.
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Zolpidem Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is this a controlled substance? A: Yes, Zolpidem Tablets are regulated. We handle the necessary export documentation.
Q: What strengths do you offer? A: We manufacture both 5mg and 10mg strengths.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Dosage: The recommended dose is 10mg once daily immediately before bedtime.
Women/Elderly: A lower dose of 5mg is often recommended for women and elderly patients due to slower metabolism.
Administration: Take on an empty stomach for faster effect. Do not take unless you have 7-8 hours to sleep.
9. Side Effects and Precautions
Common Side Effects: Drowsiness, dizziness, or headache may occur the next day.
Warning: Rare instances of complex sleep behaviors (sleep-walking, sleep-driving) have been reported.
Contraindications: Not for patients with severe liver impairment or sleep apnea.
10. Storage Instructions
Store below 25°C in a dry place.
Protect from light.
Security: Keep safely out of reach of children.
