ZOLPIDEM TARTRATE - Generic Drug Details

What are the generic drug sources for zolpidem tartrate and what is the scope of patent protection?

Zolpidem tartrate is the generic ingredient in seven branded drugs marketed by Almatica, Aytu, Cosette, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Lupin Ltd, Ph Health, Sandoz, Sun Pharm, Synthon Pharms, Biovail Labs Intl, Acme Labs, Anda Repository, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Viatris, Purdue Pharma, Dr Reddys, Novel Labs Inc, and Pharmobedient, and is included in forty-two NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has one hundred and forty-one patent family members in twenty-three countries.

There are thirty-two drug master file entries for zolpidem tartrate. Forty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ZOLPIDEM TARTRATE

International Patents:	141
US Patents:	7
Tradenames:	7
Applicants:	37
NDAs:	42
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	25
Patent Applications:	138
Drug Prices:	Drug price trends for ZOLPIDEM TARTRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOLPIDEM TARTRATE
What excipients (inactive ingredients) are in ZOLPIDEM TARTRATE?	ZOLPIDEM TARTRATE excipients list
DailyMed Link:	ZOLPIDEM TARTRATE at DailyMed

See drug prices for ZOLPIDEM TARTRATE

See drug sales revenues for ZOLPIDEM TARTRATE

Recent Clinical Trials for ZOLPIDEM TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The First Affiliated Hospital with Nanjing Medical University	NA
University of Pennsylvania	Phase 4
National Institutes of Health (NIH)	Phase 4

See all ZOLPIDEM TARTRATE clinical trials

Generic filers with tentative approvals for ZOLPIDEM TARTRATE

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET;ORAL
		5MG	TABLET;ORAL
		10MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ZOLPIDEM TARTRATE

Drug Class	gamma-Aminobutyric Acid A Receptor Positive Modulator gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Receptor Positive Modulators GABA A Agonists
Physiological Effect	Central Nervous System Depression

Anatomical Therapeutic Chemical (ATC) Classes for ZOLPIDEM TARTRATE

N05CF	Benzodiazepine related drugs
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ZOLPIDEM TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTERMEZZO	Sublingual Tablets	zolpidem tartrate	1.75 mg and 3.5 mg	022328	1	2012-04-10
EDLUAR	Sublingual Tablets	zolpidem tartrate	5 mg and 10 mg	021997	1	2010-04-29
AMBIEN CR	Extended-release Tablets	zolpidem tartrate	6.25 mg	021774	1	2006-02-24
AMBIEN CR	Extended-release Tablets	zolpidem tartrate	12.5 mg	021774	1	2006-01-19

US Patents and Regulatory Information for ZOLPIDEM TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Breckenridge	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	213592-002	Jun 4, 2020		DISCN	No	No
Ph Health	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;SUBLINGUAL	204229-002	Sep 11, 2017	AB	RX	No	No
Ph Health	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;SUBLINGUAL	201509-001	Aug 1, 2016	AB	RX	No	No
Yung Shin Pharm	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	077990-001	Apr 23, 2007		DISCN	No	No
Sandoz	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	090107-001	Jul 1, 2011	AB	RX	No	No
Sandoz	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	090107-002	Jul 1, 2011	AB	RX	No	No

Expired US Patents for ZOLPIDEM TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011	8,252,809
Cosette	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-002	Dec 16, 1992	4,382,938*PED
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	6,761,910
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008	7,632,517
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011	8,252,809
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	6,761,910

International Patents for ZOLPIDEM TARTRATE

Country	Patent Number	Title	Estimated Expiration
Japan	2007523091
European Patent Office	1534242	VAPORISATION BUCCALE, POLAIRE ET NON POLAIRE OU CAPSULE CONTENANT DES MEDICAMENTS POUR TRAITER DES MALADIES DES VOIES GASTRO-INTESTINALES OU DES VOIES URINAIRES (BUCCAL, POLAR OR NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING DISORDERS OF THE GASTROINTESTINAL TRACT OR URINARY TRACT)
Portugal	2340872
European Patent Office	1536769	VAPORISATION BUCCALE, POLAIRE ET NON POLAIRE OU CAPSULE CONTENANT DES MEDICAMENTS POUR MALADIES CARDIO-VASCULAIRES OU RENALES (BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING CARDIOVASCULAR OR RENAL DRUGS)
Canada	2497114	CAPSULE OU VAPORISATEUR BUCCAL, POLAIRE ET NON POLAIRE, CONTENANT DES MEDICAMENTS POUR LE TRAITEMENT DE TROUBLES METABOLIQUES (BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FORTREATING METABOLIC DISORDERS)
South Korea	20140104986	COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF

Supplementary Protection Certificates for ZOLPIDEM TARTRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718

Market Dynamics and Financial Trajectory for Zolpidem Tartrate

Last updated: July 27, 2025

Introduction
Zolpidem tartrate, a non-benzodiazepine hypnotic agent primarily prescribed for short-term management of insomnia, remains a significant segment within the global pharmaceutical landscape. Its market trajectory is shaped by evolving prescription guidelines, regulatory considerations, generic entry, and emerging alternatives. Analyzing these factors provides a comprehensive view of its current standings and forecasted financial performance.

Market Overview
Zolpidem tartrate, marketed under brands like Ambien and Stilnox, was first launched in the early 1990s and swiftly gained prominence as a preferred sleep aid. Its mechanism involves selective modulation of GABA-A receptors, resulting in sedative effects with a comparatively favorable safety profile versus benzodiazepines. The global market for zolpidem was valued at approximately US$1.2 billion in 2022, with North America dominating due to high prescription rates and favorable regulatory environments.

Market Drivers

1. Prevalence of Sleep Disorders
   The rising incidence of insomnia globally, exacerbated by lifestyle factors, aging demographics, and increased mental health awareness, sustains demand for hypnotic agents. According to the World Sleep Society, over 30% of adults report sleep difficulties, underpinning steady prescription trends.

2. Pharmaceutical Innovation and Expanded Indications
   While primarily indicated for insomnia, ongoing clinical trials exploring zolpidem’s off-label uses or combination therapies could open new revenue streams. Nonetheless, current focus remains on its core use, with minimal diversification.

3. Regulatory Framework and Prescribing Guidelines
   Stringent FDA guidelines in the U.S. and similar standards across Europe have prioritized safety, emphasizing short-term use to mitigate dependence risk. Regulatory shifts toward tighter controls may modulate market size but also elevate generic competition.

4. Growing Preference for Generics
   Post-patent expiration, generic versions have entered the market, significantly reducing wholesale prices and pressuring branded formulations. As of 2022, generics accounted for over 80% of zolpidem prescriptions in the U.S., driving volumes but compressing profit margins for original manufacturers.

Market Challenges

1. Safety Concerns and Regulatory Actions
   Reports of complex sleep-related behaviors (e.g., sleepwalking, amnesia) have led to FDA black box warnings. These safety signals have prompted prescriber caution, potentially affecting utilization volumes.

2. Alternative Therapeutics
   Emergence of newer agents, such as suvorexant (a dual orexin receptor antagonist) and melatonin receptor agonists like ramelteon, offer alternative treatment options with potentially lower safety concerns. Their growing market share could cannibalize zolpidem’s demand.

3. Dependence and Abuse Potential
   Regulatory agencies classify zolpidem as a controlled substance (Schedule IV in the U.S.), imposing strict prescribing limits. This classification curtails misuse but limits long-term usage, emphasizing short-term prescribing.

4. Market Saturation and Price Erosion
   Intensified competition from generic suppliers results in eroded revenue streams for branded products. Manufacturers are compelled to focus on cost efficiencies and marketing strategies to sustain profitability.

Financial Trajectory Forecast (2023-2030)

• Short-term Outlook (2023-2025):
  Following patent expiration, generics will dominate. Revenue for original patent holders is expected to decline sharply, with an estimated compound annual decline rate (CAGR) of approximately 15%. However, volume-based sales may stabilize due to persistent unmet demand for effective sleep aids.

• Medium-term Outlook (2025-2027):
  Market entrants may introduce modified formulations or extended-release versions, fostering incremental growth. Regulatory pressures may lead to downward price adjustments, but innovation could insulate some revenue streams.

• Long-term Outlook (2027-2030):
  Growth prospects hinge on the pipeline development of newer therapeutics, shifting prescriber preferences, and regulatory landscapes. The overall market for zolpidem is projected to plateau or decline modestly, with a possible CAGR of -2% to 0%. However, niche markets such as elderly care facilities could sustain persistent demand.

Strategic Opportunities

• Formulation Innovation: Developing formulations with improved safety profiles or reduced dependence potential can differentiate products.
• Geographic Expansion: Emerging markets with rising sleep disorder prevalence present growth avenues, particularly where regulatory barriers are less stringent.
• Combination Therapies: Partnering with mental health or sleep disorder specialists to explore combination treatments could unlock new revenue streams.
• Regulatory Engagement: Active dialogue with regulators to refine safety monitoring may foster market confidence and extended lifecycle management.

Conclusion
Zolpidem tartrate’s future hinges on balancing its entrenched role in sleep disorder management against safety concerns and evolving therapeutic options. While patent expiries and generics have compressed margins, strategic innovation and market adaptation can preserve profitability. Understanding these dynamics is essential for stakeholders aiming to navigate the complex pharmaceutical environment surrounding this longstanding hypnotic.

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Key Takeaways

• Market Decline Post-Patent: Patent expiration led to increased generic competition, drastically reducing revenue margins for branded zolpidem formulations.
• Demand Persistence: Despite safety concerns, the high prevalence of insomnia sustains consistent demand, especially in developed markets.
• Regulatory Impact: Stringent safety warnings and classification as a controlled substance influence prescribing behaviors and market size.
• Emerging Therapeutics: Competitors like suvorexant and ramelteon are capturing market share, posing challenges to zolpidem’s dominance.
• Strategic Innovation: Developing safer formulations and expanding into emerging markets can mitigate revenue loss and diversify growth vectors.

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Frequently Asked Questions (FAQs)

1. How has patent expiration affected zolpidem tartrate’s market share?
Patent expiration facilitated the entry of generic manufacturers, significantly reducing prices and shifting most prescriptions from branded to generic versions. This transition led to an approximate 80% market share being held by generics in the U.S. as of 2022, thereby decreasing revenues for original innovators.

2. What safety concerns have influenced zolpidem’s regulatory status and prescribing patterns?
Reports of complex sleep-related behaviors and dependence risks prompted the FDA to issue black box warnings, making physicians more cautious in prescribing. These safety issues, coupled with regulatory restrictions like Schedule IV classification, have limited long-term use and market growth.

3. Are there emerging alternatives that threaten zolpidem’s market dominance?
Yes, drugs such as suvorexant and ramelteon offer different mechanisms with potentially improved safety profiles. Their increasing acceptance, supported by clinical trials and regulatory endorsement, is gradually reducing zolpidem’s market share.

4. What is the projected financial trajectory of zolpidem tartrate over the next decade?
The market is expected to decline modestly, with a CAGR of around -2% to 0%, driven by generic competition, safety concerns, and competing agents. Strategic formulation improvements and geographic expansion are potential mitigators of this decline.

5. How can pharmaceutical companies sustain profitability with zolpidem in a competitive landscape?
Innovations such as extended-release formulations, combination therapies, and targeting niche markets can help sustain revenue. Additionally, engaging proactively with regulators to improve safety profiles and pursuing emerging markets can provide growth pathways.

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Sources:
[1] World Sleep Society. (2022). Sleep Statistics and Trends.
[2] U.S. Food & Drug Administration. (2020). Zolpidem Safety Labeling Changes.
[3] IMS Health. (2022). Pharmaceutical Market Report.
[4] MarketWatch. (2023). Sleep Disorder Drugs Market Analysis.
[5] EvaluatePharma. (2023). 2022 World Market Forecast for Sedative-Hypnotics.