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Zolpidem Tartrate is a non-benzodiazepine hypnotic agent used primarily for the short-term treatment of insomnia. It acts as a GABA-A receptor agonist, promoting sedation and improving sleep onset with minimal next-day drowsiness. Zolpidem has a rapid onset of action and short half-life, making it effective for individuals who struggle with sleep initiation without causing dependence or significant residual effects.
At Bluepill Express, we manufacture high-purity Zolpidem Tartrate API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring international compliance and unmatched product consistency. Our Zolpidem Tartrate complies with IP, BP, USP, and EP pharmacopoeial standards and is ideal for tablet and capsule formulations targeting the global insomnia treatment market.
Therapeutic Uses
- Insomnia: Helps in initiating and maintaining sleep
- Transient Sleep Disturbances: Effective for short-term therapy
- Sleep Onset Disorders: Reduces sleep latency and nighttime awakenings
- Improved Sleep Quality: Provides restful, uninterrupted sleep cycles
- Adjunct in Stress-Related Sleep Disorders: Calms overactive neural pathways
Mechanism of Action
Zolpidem binds selectively to the benzodiazepine (BZ1) site of the GABA-A receptor complex, enhancing the inhibitory effect of GABA neurotransmission in the brain.
This leads to:
- Sedation and hypnosis without muscle relaxation
- Rapid onset and short duration of action
- Minimal interference with natural sleep architecture
Pharmacological Information
- Chemical Name: N,N,6-trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide L-(+)-tartrate (2:1)
- Molecular Formula: C23H27N3O7
- Molecular Weight: 465.48 g/mol
- CAS Number: 99294-93-6
- Therapeutic Class: Sedative / Hypnotic
- Pharmacological Class: Non-Benzodiazepine GABA-A Receptor Modulator
- ATC Code: N05CF02
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in water and alcohol; sparingly soluble in chloroform |
| Melting Point | 192°C – 196°C |
| pH (1% solution) | 5.0 – 7.0 |
| Storage | Store below 25°C in a dry, cool place, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Specific Optical Rotation | +15° to +18° |
| Bulk Density | 0.40 – 0.60 g/mL |
Applications
Zolpidem Tartrate API is used in:
- Tablet formulations (immediate and extended release) for insomnia
- Oral disintegrating tablets for rapid action
- Fixed-dose combination therapies for sleep and anxiety disorders
- Export supply to regulated and semi-regulated markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Includes product name, batch number, manufacturing and expiry date, storage instructions
- Shelf Life: 36 months under recommended conditions
- Export Markets: Europe, Africa, Asia, Middle East, Latin America
