Product Name: Zolpidem Hemitartrate
Chemical Name: N,N,6-Trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide Hemitartrate
Synonyms: Zolpidem Tartrate, Ambien, Stilnox
Molecular Formula: C19H21N3O•0.5C4H6O6
Molecular Weight: 488.44 g/mol
CAS Number: 82626-48-0 (Zolpidem), 99294-93-6 (Zolpidem Tartrate)
Manufacturer Information: Provided upon request
Intended Use: Pharmaceutical sedative for treatment of insomnia
Hazard Classification: Not classified as hazardous according to GHS for supplied form in typical workplace quantities, but may cause health issues upon exposure to large quantities
GHS Label Elements: None for pharmaceutical use; potential irritant
Potential Health Effects: Ingestion may lead to central nervous system depression, drowsiness, confusion, loss of consciousness; inhalation could irritate respiratory tract
Target Organs: Central Nervous System
Environmental Hazards: Harmful to aquatic life; persistence in water systems has consequences for wildlife
Chemical Components: Zolpidem Hemitartrate 98-100%
Impurities: Related substances below regulatory thresholds
Excipients: None in pure form
Dangerous Components: Not classified as carcinogenic or mutagenic
Ingredient EINECS/ELINCS Number: 620-504-0 (Zolpidem base)
Inhalation: Move affected person to fresh air; seek medical attention if symptoms develop, such as dizziness, drowsiness, or respiratory distress
Ingestion: Rinse mouth, drink water if conscious; seek immediate medical advice; do not induce vomiting unless directed by medical personnel
Skin Contact: Remove contaminated clothing, wash skin with water and mild soap; seek attention if irritation develops
Eye Contact: Rinse eyes gently with running water for several minutes, remove contact lenses if present; get medical aid if symptoms persist
Most Important Symptoms: Sedation, confusion, ataxia, respiratory depression in severe cases
Flammability: Not highly flammable, but dust accumulations may pose risk
Suitable Extinguishing Media: Water spray, dry chemical powder, carbon dioxide, foam
Specific Hazards: Decomposition can yield toxic fumes such as nitrogen oxides and carbon monoxide
Protective Equipment: Use self-contained breathing apparatus and full protective gear
Firefighting Instructions: Try to prevent runoff; ventilate area after fire
Combustion Products: Irritant and harmful gases likely during combustion
Personal Precautions: Wear gloves, lab coat, eye protection, possibly dust mask in case of powder spill
Environmental Precautions: Prevent leak or spill from entering drains or watercourses
Cleanup Methods: Sweep up using dustless methods, place material in suitable container for disposal; ventilate area, avoid raising dust
Decontamination: Wash spill area thoroughly
Disposal: Follow local regulatory requirements for pharmaceutical waste
Handling Guidelines: Use in well-ventilated setting; avoid direct contact with substance; prevent dust or powder formation
Storage Conditions: Store in tightly closed containers in a cool, dry, well-ventilated place; avoid excessive heat or light exposure
Specific Storage Instructions: Keep away from incompatible substances such as strong oxidizers
Incompatibilities: Strong acids, bases, oxidizers may degrade or react
Safe Transfers: Use mechanical aids or safety equipment to minimize exposure
Occupational Exposure Limits: No occupational exposure limit established for zolpidem tartrate
Engineering Controls: Local exhaust ventilation or containment for handling large quantities
Personal Protective Equipment: Protective gloves (nitrile recommended), laboratory coat, eye protection (goggles), dust mask or respirator if risk of inhalation
Hygiene Measures: Do not eat, drink, or smoke during use; wash hands after handling
Respiratory Protection: Use particulate respirator if airborne dust is generated
Eye/Face Protection: Wear safety goggles or face shield
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: ~6 in aqueous solution
Melting Point: 162–166 °C (pure zolpidem base)
Boiling Point: Data not available for tartrate salt
Flash Point: Not applicable
Solubility: Freely soluble in water, methanol
Partition Coefficient (log Pow): 2.8 (zolpidem base)
Vapor Pressure: Negligible
Decomposition Temperature: >200 °C
Chemical Stability: Stable under standard temperature and pressure
Hazardous Reactions: No hazardous reactions under normal conditions
Incompatible Materials: Strong oxidizers, acids, and bases
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide
Polymerization: Will not occur
Acute Toxicity: Median lethal dose (LD50) for oral administration in rats: 200–400 mg/kg
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms of Overexposure: Drowsiness, confusion, ataxia, respiratory depression, hypotension
Chronic Effects: Potential for dependence and abuse, impairment of cognitive and motor performance
Carcinogenicity: Animal studies show no evidence; not listed by IARC, NTP, OSHA
Mutagenicity: Negative in standard tests
Reproductive Toxicity: Animal studies show decreased fertility and maternal toxicity at high doses
Ecotoxicity: Harmful to aquatic organisms; risk of environmental persistence
Aquatic Toxicity: Data indicate risk to fish and aquatic invertebrates at low concentrations
Degradability: Not readily biodegradable in water systems; persistent pharmaceutical contaminant documented in studies
Bioaccumulative Potential: Relatively low, though metabolites may accumulate
Mobility in Soil: Moderate; potential to reach groundwater in significant spills
Other Adverse Effects: Potential to disrupt aquatic ecosystems
Waste Management: Treat as hazardous pharmaceutical waste
Disposal Methods: Incineration in approved facility; avoid landfill or sewer disposal
Contaminated Packaging: Dispose of as hazardous waste according to local laws
Special Precautions: Do not re-use empty containers; destroy packaging
Legal Requirements: Comply with federal, state, and local environmental regulations
UN Number: Not classified as dangerous for transport under current international regulation in typical quantities
UN Proper Shipping Name: Not regulated
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Marine Pollutant: No, not classified as marine pollutant
Transport Precautions: Protect from excessive heat, keep secure, avoid damage to packaging; emergency response instructions recommended for bulk transfer
US Federal Regulations: Controlled Substance Schedule IV under DEA, prescription use only; not listed under SARA Title III sections
TSCA Status: Exempt as a drug
Canada DSL/NDSL: Not listed
EU Regulations: Listed under active pharmaceutical ingredients, subject to medicinal product regulation
OSHA Hazard Communication: Not hazardous chemical in product use
Other Regulatory Information: Comply with relevant national and international regulations governing medicinal products and controlled substances; employee exposure limits may apply in certain jurisdictions
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