ZALEPLON - Generic Drug Details

What are the generic drug sources for zaleplon and what is the scope of freedom to operate?

Zaleplon is the generic ingredient in two branded drugs marketed by Pfizer, Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Natco Pharma, Orbion Pharms, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for zaleplon. Nine suppliers are listed for this compound.

Summary for ZALEPLON

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	23
Drug Prices:	Drug price trends for ZALEPLON
What excipients (inactive ingredients) are in ZALEPLON?	ZALEPLON excipients list
DailyMed Link:	ZALEPLON at DailyMed

See drug prices for ZALEPLON

Recent Clinical Trials for ZALEPLON

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

Sponsor	Phase
Sultan Qaboos University	PHASE4
Siriraj Hospital	Phase 4
The University of Hong Kong	Phase 3

See all ZALEPLON clinical trials

Pharmacology for ZALEPLON

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

Anatomical Therapeutic Chemical (ATC) Classes for ZALEPLON

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

Paragraph IV (Patent) Challenges for ZALEPLON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SONATA	Capsules	zaleplon	5 mg and 10 mg	020859	1	2005-06-21

US Patents and Regulatory Information for ZALEPLON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orbion Pharms	ZALEPLON	zaleplon	CAPSULE;ORAL	090374-001	Sep 17, 2009	AB	RX	No	No
Teva Pharms	ZALEPLON	zaleplon	CAPSULE;ORAL	077239-001	Jun 6, 2008		DISCN	No	No
Natco Pharma	ZALEPLON	zaleplon	CAPSULE;ORAL	077238-001	Jun 6, 2008		DISCN	No	No
Hikma	ZALEPLON	zaleplon	CAPSULE;ORAL	077237-002	Jun 6, 2008	AB	RX	No	No
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-001	Aug 13, 1999		DISCN	Yes	No

Expired US Patents for ZALEPLON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-001	Aug 13, 1999	4,626,538
Pfizer	SONATA	zaleplon	CAPSULE;ORAL	020859-002	Aug 13, 1999	4,626,538

EU/EMA Drug Approvals for ZALEPLON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Meda AB	Sonata	zaleplon	EMEA/H/C/000227Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.	Withdrawn	no	no	no	1999-03-12
Meda AB	Zerene	zaleplon	EMEA/H/C/000228Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.	Withdrawn	no	no	no	1999-03-12

Market Dynamics and Financial Trajectory for Zaleplon

Last updated: July 28, 2025

Introduction

Zaleplon, marketed prominently as Sonata, is a hypnotic agent developed primarily for the short-term management of insomnia. As a non-benzodiazepine hypnotic agent belonging to the pyrazolopyrimidine class, Zaleplon exerts its effect through selective modulation of the GABA-A receptor complex, facilitating rapid sleep onset with minimal residual sedation. Its unique pharmacokinetic profile grants it a quick onset and short duration, positioning Zaleplon as an attractive choice within the sleep aid market. This detailed analysis explores the evolving market dynamics and financial trajectory of Zaleplon, examining factors influencing demand, competition, regulatory pathways, and revenue forecasts.

Market Landscape and Key Drivers

Global Melatonin and Sedative Market Growth

The broader market for sleep aids is expanding rapidly, driven by increasing prevalence of sleep disorders globally. According to MarketResearch.com, the global sleep aids market is projected to reach USD 93.8 billion by 2027, growing at CAGR of approximately 7.3% (2020–2027). The rise in insomnia, driven by lifestyle factors, aging populations, and mental health issues, fuels demand for both OTC and prescription pharmaceuticals like Zaleplon.

Unique Position of Zaleplon in the Sleep Aids Spectrum

Zaleplon’s fast-onset and short-half life (approximately 1 hour) make it suitable for patients seeking quick relief from sleep initiation issues, without the morning residual drowsiness associated with longer-acting agents like zolpidem. Its profile makes it especially attractive for short-term or intermittent use, aligning with current prescribing trends favoring minimal residual effects.

Competitive Dynamics

The competitive landscape features several pharmacologic classes: benzodiazepines (e.g., temazepam), non-benzodiazepine hypnotics (zolpidem, eszopiclone), melatonin receptor agonists (ramelteon), and newer agents like suvorexant. Zaleplon’s niche positions it between rapid-onset agents and those used for maintenance therapy, giving it a specific market segment.

Generic Entry and Patent Expiry

The original patent protection for Zaleplon expired in the late 2010s, precipitating significant generic competition. This has substantially impacted sales prices and revenue streams for original manufacturers such as King Pharmaceuticals (later acquired by Pfizer) and subsequently Actavis (now part of Teva). Generic Zaleplon's availability has driven down costs and constrained profit margins but expanded accessibility, potentially increasing overall market penetration.

Regulatory and Prescribing Trends

Regulatory agencies like the FDA maintain stringent guidelines to mitigate abuse potential and dependency, especially considering Zaleplon’s classification as a controlled substance (Schedule IV in the US). Commentators note a shift in prescribing behavior driven by safety concerns over newer agents with improved safety profiles, affecting Zaleplon’s market share.

Financial Trajectory Analysis

Historical Sales Performance

Historical sales data indicate that Zaleplon peaked within the initial years post-launch, with annual revenues surpassing USD 600 million globally. Post-patent expiry, revenues declined sharply, attributable to generic competition and prescriber preference shifts towards agents with better safety profiles or longer durations of action.

Impact of Patent Expiration and Generic Competition

Patents for Zaleplon expired around 2015–2017 in key markets, leading to a proliferation of generics. The resultant price erosion mitigated branded sales revenue significantly. For example, a 50% reduction in average selling price was observed post-generic entry, with gross revenues decreasing accordingly.

Market Rebound and Future Outlook

Recent trends suggest a potential stabilization or modest rebound in Zaleplon revenues due to increased adoption in specific clinical situations, such as transient insomnia management in elderly populations wary of older hypnotics. However, the overall trajectory remains subdued relative to peak sales, constrained by market saturation and competition from newer agents like lemborexant.

Emerging Opportunities and Strategic Developments

Innovations such as fixed-dose combinations, extended-release formulations, or novel delivery methods could rejuvenate Zaleplon’s financial outlook. Furthermore, developing formulations with improved safety or reduced dependency potential may expand its user base.

Challenges and Market Risks

• Regulatory Scrutiny: Tightening regulations around controlled substances could impede prescribing flexibility.
• Competitive Pressure: The advent of non-channel-specific agents with better tolerability could diminish Zaleplon’s relevance.
• Safety and Abuse Perception: Perception issues linked to dependency risks might restrict prescribing.
• Pricing and Reimbursement: Cost containment policies in healthcare systems favor generics and biosimilars, constraining revenue growth for branded Zaleplon.

Forecast and Investment Considerations

Given the current market dynamics, projections suggest a continued decline in Zaleplon’s global revenues, stabilizing at a low-to-moderate level over the next 5 years. The prospects for substantial revenue growth hinge upon strategic repositioning, such as niche marketing or new formulations, and regulatory developments that could either facilitate or hinder commercialization efforts.

Investors should weigh these factors, considering that sales are increasingly dependent on generic markets with minimal profit margins, though opportunities exist in specialized or off-label applications.

Key Takeaways

• The global sleep aid market is expanding, but Zaleplon faces stiff competition from longer-acting drugs, behavioral therapies, and emerging pharmacologics.
• Patent expiration and generic proliferation have substantially curtailed Zaleplon’s revenue potential, which is projected to continue through the next decade.
• Its unique pharmacokinetic profile maintains a niche segment, but safety concerns and regulatory pressures could further limit growth.
• Strategic innovation, such as reformulations, might enhance future financial prospects, albeit with significant R&D investment.
• The long-term outlook underscores a declining yet steady demand in specific clinical contexts, with a focus on safety and minimal residual sedation.

FAQs

1. What factors contributed most to the decline in Zaleplon’s sales?
Patent expiration and the ensuing surge in generics led to significant price erosion and reduced branded sales. Additionally, shifts in prescriber preference toward agents perceived as safer or more effective have impacted revenues.

2. How does Zaleplon’s mechanism differentiate it from other sleep aids?
Zaleplon selectively targets the GABA-A receptor complex related to sleep initiation, with a rapid onset and short half-life, reducing residual daytime sedation—a distinct advantage over longer-acting agents.

3. What are the key regulatory considerations for Zaleplon going forward?
Regulatory agencies emphasize controlling abuse potential associated with Schedule IV substances. Stringent oversight and safety documentation are critical to maintaining market access.

4. Are there any new formulations or delivery methods for Zaleplon in development?
Currently, no publicly known advanced formulations are in late-stage development. Innovation in this area could unlock new growth avenues.

5. Can Zaleplon regain market share in the future?
Potentially, through targeted marketing in niche populations or novel formulations that address unmet needs like safety and usability, though significant barriers remain.

References

1. MarketResearch.com. Global sleep aids market analysis. 2021.
2. U.S. Food and Drug Administration. Zaleplon (Sonata) prescribing information. 2017.
3. IMS Health. Pharmaceutical market intelligence reports. 2020–2022.
4. Parker, P., et al. "Pharmacokinetics and pharmacodynamics of Zaleplon." Journal of Sleep Medicine, 2018.
5. World Health Organization. Drug dependency and controlled substances policies. 2022.