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Last Updated: July 29, 2025

Drugs in MeSH Category Sleep Aids, Pharmaceutical


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ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Anabolic DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 083275-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Elkins Sinn DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride CAPSULE;ORAL 085701-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Jubilant Cadista DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 215483-003 Mar 14, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Leading DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 211619-005 Mar 9, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Mcneil Cons BENADRYL diphenhydramine hydrochloride CAPSULE;ORAL 005845-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Quantum Pharmics DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 070973-001 Sep 29, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Strides Pharma DOXEPIN HYDROCHLORIDE doxepin hydrochloride TABLET;ORAL 202510-002 Jul 24, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
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Sleep Aids, Pharmaceutical Market Analysis and Financial Projection

Last updated: July 27, 2025

The global market for pharmaceutical sleep aids is experiencing robust growth, driven by rising sleep disorder prevalence and technological innovation. Valued at $81.8 billion in 2023, the market is projected to reach $134.97 billion by 2031, with a 6.46% CAGR[1][6][12]. Key dynamics and patent trends include:

Market Dynamics

Growth Drivers:

  • Insomnia dominance: Accounting for ~38.7% of sleep disorder treatments, insomnia therapies like daridorexant (Quviviq) and suvorexant drive segment growth, with the U.S. prescription sleep aid market alone projected to exceed $15.3B by 2032[1][8][18].
  • Technological convergence: AI-powered solutions like Fullpower-AI’s Sleeptracker® (protected by US Patents 11,793,455 and 11,766,213) bridge pharmaceuticals with IoT-enabled sleep environment optimization[5].
  • Mental health links: 17.3M+ U.S. adults with depression (a common comorbidity) accelerate demand for dual-action antidepressants/sedatives[2][6].

Key Challenges:

  • Side effect concerns: 30% of users report residual drowsiness from benzodiazepines, while antihistamines face safety scrutiny[2][18].
  • Cost barriers: Chronic insomnia treatment averages $1,200+/year, limiting access in developing markets[2][20].

Regional Outlook:

  • North America leads (45% market share), while Asia-Pacific grows fastest (6.5% CAGR in Japan)[12][16].
  • China emerges as top patent filer, surpassing U.S. in soft sleep solution innovations[17].

Patent Landscape

Innovation Hotspots:

  1. Novel delivery systems:

    • Curio Wellness’ pulse-release cannabis tablet (US Patent 11,945,778) for sustained effect[14]
    • Archimedes’ intranasal zolpidem formulation (US 8,034,371) reducing next-day impairment[13]
  2. Disease-specific targets:

    • Enveric’s psilocin prodrug (EB-002) patented for dementia-related sleep disorders (US 11,945,778)[9]
    • Corundum Neuroscience’s EEG-based dementia biomarker detection method[1]
  3. Combo therapies:

    • Iomedix’s valerian-melatonin-willow bark supplements (US 7,914,826)[13]
    • Zonisamide formulations for OSA comorbidity management (US 7,655,681)[13]

Strategic Trends:

  • 72% of new patents focus on non-addictive alternatives to z-drugs[13][19]
  • Secondary patents surge for OTC melatonin (16% CAGR 2018-2025), covering sustained-release formats and combination products[19][4]
  • Litigation risks increase, as seen in Purdue Pharma’s invalidated Intermezzo® patents[10]

Emerging Opportunities

  • Dementia sleep solutions: Low-dose trazodone shows 8.53% sleep efficiency improvement in Alzheimer’s patients (95% CI 1.9–15.1)[11]
  • Precision sleep medicine: 43% of pipeline drugs target orexin receptors versus 29% GABAergics[9][18]
  • OTC expansion: Melatonin supplements projected to hit $25.5B by 2030, with patented delayed-release variants capturing 22% revenue share[4][19]

This market-innovation nexus is reshaping sleep healthcare, with patent portfolios becoming critical for commercial success. As developer Dr. Joseph Tucker notes: “Comprehensive IP protection derisks clinical development and accelerates patient access to breakthrough therapies”[9]. The interplay of pharmacological advances and connected health technologies will likely define next-generation sleep solutions.

References

  1. https://www.marketsandata.com/industry-reports/sleep-aids-market
  2. https://www.databridgemarketresearch.com/reports/global-sleeping-medications-market
  3. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(F03)
  4. https://www.knowledge-sourcing.com/report/otc-sleep-aids-medication-market
  5. https://www.santacruzworks.org/news/Fullppatent11
  6. https://www.delveinsight.com/blog/sleep-aids-market-trends
  7. https://meshb.nlm.nih.gov/record/ui?ui=D006993
  8. https://markets.businessinsider.com/news/stocks/insights-into-the-global-insomnia-drugs-market-to-2025-featuring-astellas-pharma-flynn-pharma-pfizer-among-others-1029045190
  9. https://sleepreviewmag.com/sleep-treatments/pharmaceuticals/emerging-compounds/investigational-psilocin-prodrug-gains-patent-protection-sleep-disorder-applications/
  10. https://www.robinskaplan.com/newsroom/news/federal-circuit-upholds-ruling-in-favor-of-novel-laboratories-sleep-aid-patent-case
  11. https://pmc.ncbi.nlm.nih.gov/articles/PMC8094738/
  12. https://www.thebrainyinsights.com/report/sleep-aids-market-13768
  13. https://patents.justia.com/patents-by-us-classification/514/923
  14. https://sleepreviewmag.com/sleep-health/cannabis-sleep-aid-us-patent-pulse-release-dosing/
  15. https://meshb.nlm.nih.gov/record/ui?ui=D000068776
  16. https://www.grandviewresearch.com/industry-analysis/insomnia-therapeutics-market
  17. https://sleepreviewmag.com/sleep-health/prevailing-attitudes/future-of-sleep/sleep-market-innovators-invest-soft-sleep-solutions/
  18. https://www.gminsights.com/industry-analysis/sleep-medications-market
  19. https://www.youtube.com/watch?v=EfTK3WfJRS0
  20. https://www.alliedmarketresearch.com/us-sleep-aids-market-A265504

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