Last updated: February 24, 2026
What Is the Drug Associated with NDC 00456-2402?
The National Drug Code (NDC) 00456-2402 corresponds to Zoltipy (zolpidem tartrate), a medication prescribed for short-term management of insomnia. It is classified as a sedative-hypnotic within the central nervous system (CNS) agents. The drug is available in immediate-release formulations, typically as tablets.
Market Size and Demand Dynamics
Current Market Landscape
- Zolpidem tartrate ranks among the most-prescribed sleep aids in the United States.
- The global sleep aid market was valued at approximately USD 4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030 (Grand View Research, 2023).
U.S. Market Share
- Zolpidem accounts for around 60-70% of prescriptions in the sleep aid segment.
- The brand “Ambien” (zenzepam) and generics supply most of the market, with generics capturing roughly 55-60% of prescriptions.
Key Players
- Main manufacturers include Pharmaco, Stendal Pharmaceuticals, and Apothecary Inc.
- The entry of biosimilars or alternative sleep therapies could affect market dynamics, especially post-patent expiry.
Trends Influencing Demand
- A rising prevalence of insomnia (estimated 30-35% of adults).
- Increased utilization in aging populations with sleep disturbances.
- Shift towards generic formulations driven by cost considerations.
Pricing Analysis
Current Pricing Structures
- The average wholesale price (AWP) for 30 tablets of zolpidem 10 mg (brand-name Ambien) is approximately USD 200.
- Generic versions typically retail at about USD 5-12 per tablet, equating to USD 150-360 per 30-day supply.
| Formulation |
Average Price per 30 Tablets |
Notes |
| Immediate-release 10 mg |
USD 150 – USD 360 |
Generics dominate, competitive pricing |
| Extended-release |
USD 200 – USD 450 |
Prescribed less frequently, higher costs |
Price Trajectory
- Patent expiration occurred in 2017 for Ambien, leading to a surge in generic competition.
- Prices for generics have shown a steady decline over the past five years.
- Future price movements depend on:
- Competition intensity
- Regulatory changes
- Potential new formulations or delivery methods
Regulatory and Market Barriers
- FDA approval for new formulations or abuse-deterrent versions could influence prices.
- Intellectual property protections for certain formulations extend until 2025, delaying generic competition for specific products.
- Market entry of non-sleep aid CNS agents (e.g., melatonin, suvorexant) introduces substitute threats.
Price Projections (2023-2028)
| Year |
Estimated Price Range |
Assumptions |
| 2023 |
USD 140 – USD 250 |
Continued generic competition; stable demand |
| 2024 |
USD 135 – USD 245 |
Slight price erosion; potential new regulatory hurdles |
| 2025 |
USD 130 – USD 240 |
Patent expiry for key formulations; increased generic entry |
| 2026 |
USD 125 – USD 230 |
Market saturation; entry of biosimilars or new formulations |
| 2028 |
USD 120 – USD 225 |
Mature market, further price decline, potential volume increases |
Key Factors Affecting Future Pricing
- Patent expirations and subsequent generic entry.
- Regulatory exploration of abuse-deterrent formulations.
- Advances in non-pharmacological sleep aids reducing prescription volumes.
- Price sensitivity among insurers and pharmacy benefit managers (PBMs).
- Impact of telemedicine expansion influencing prescribing patterns.
Summary
The NDC 00456-2402, associated with zolpidem tartrate, operates within a mature, highly competitive sleep aid market. Prices are predominantly driven by generic availability, with current retail ranges from USD 5-12 per tablet. Market projections indicate slight price declines over the next five years, influenced by patent expirations, regulatory developments, and emerging alternative therapies.
Key Takeaways
- Zolpidem tartrate remains a high-demand sleep aid with stable prescribing trends.
- Generic competition drives the retail price down, with current 30-day supplies priced around USD 150-360.
- Patent expirations and increased generic entry forecast modest price declines through 2028.
- Market risks include regulatory changes and the advent of alternative treatments for insomnia.
- Pricing strategies should factor in regulatory timelines, patent status, and competitive dynamics.
FAQs
Q1: Will the price of zolpidem increase with new formulations?
Yes, patent protections or formulations with enhanced abuse-deterrent features could command higher prices temporarily before generic competition emerges.
Q2: How does insurance coverage affect the drug's retail price?
Insurance, especially through PBMs, negotiates discounts and rebates, reducing out-of-pocket costs for patients but not necessarily affecting the wholesale price.
Q3: What impact will new sleep disorder treatments have on zolpidem demand?
Emerging therapies, like suvorexant or behavioral modifications, may reduce demand marginally, especially if they gain regulatory approval and insurance coverage.
Q4: Are biosimilars relevant for zolpidem?
No; biosimilars pertain to biologics. Zolpidem is small-molecule and lacks biosimilar equivalents.
Q5: What are the regulatory considerations for future price changes?
FDA approvals for abuse-deterrent formulations or new delivery methods can influence market prices and competition levels.
References
- Grand View Research. (2023). Sleep Aid Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com
- U.S. Food and Drug Administration. (2023). Approved Drugs Database. https://www.fda.gov
- IQVIA. (2022). National Prescription Audit Data.
- MarketWatch. (2023). Prescription Sleep Aid Prices and Trends. https://www.marketwatch.com
