Skip to main content
SpringerLink
Log in

Suvorexant: First Global Approval

  • R&D Insight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Suvorexant (Belsomra®), a first-in-class, orally active dual orexin-1 receptor and orexin-2 receptor antagonist, has been developed by Merck for the treatment of insomnia. Variations in the levels of the neuropeptides orexin A and orexin B have been linked to circadian rhythms and wakefulness. Orexin-producing neurons in the lateral hypothalamus regulate wakefulness by signalling through orexin receptors. Blockade of orexin receptors is known to promote sleep. Suvorexant was approved in the US in August 2014 for the treatment of adults with sleep onset and/or sleep maintenance insomnia. The drug is also preregistration in Japan, with approval submissions planned for other countries worldwide for this indication. This article summarizes the milestones in the development of suvorexant leading to this first approval for insomnia.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Buyssee DJ. Insomnia. JAMA. 2013;309(7):706.

    Article  Google Scholar 

  2. Mieda M, Sakurai T. Orexin (hypocretin) receptor agonists and antagonists for treatment of sleep disorders: rationale for development and current status. CNS Drugs. 2013;27(2):83–90.

    Article  PubMed  CAS  Google Scholar 

  3. US Food and Drug Administration. FDA approves new type of sleep drug, Belsomra [media release]. 13 August 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409950.htm.

  4. Merck & Co. BELSOMRA® (suvorexant) US prescribing information. 2014. http://www.merck.com/product/usa/pi_circulars/b/belsomra/belsomra_pi.pdf. Accessed 18 Aug 2014.

  5. Merck & Co. Merck receives Complete Response Letter for suvorexant, Merck’s investigational medicine for insomnia [media release]. 1 July 2013. http://www.merck.com.

  6. US Federal Register. Schedules of controlled substances: placement of suvorexant into schedule IV. 2014. https://www.federalregister.gov/articles/2014/08/28/2014-20515/schedules-of-controlled-substances-placement-of-suvorexant-into-schedule-iv?utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov. Accessed 10 Sep 2014.

  7. Connor K, Budd K, Snavely D, et al. Efficacy and safety of suvorexant, an orexin receptor antagonist, in patients with primary insomnia: a 3-month phase 3 trial (trial #1) [abstract no. O324]. J Sleep Res. 2012;21(Suppl 1):97.

    Google Scholar 

  8. Ivgy-May N, Leibensperger H, Froman S, et al. Efficacy and safety of suvorexant, an orexin receptor antagonist, in patients with primary insomnia: a 3-month phase 3 trial (trial #2) [abstract no. P988]. J Sleep Res. 2012;21(Suppl 1):351–2.

    Google Scholar 

  9. Michelson D, Snyder E, Paradis E, et al. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014;13(5):461–71.

    Article  PubMed  CAS  Google Scholar 

  10. Herring WJ, Snyder E, Budd K, et al. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012;79(23):2265–74.

    Article  PubMed  CAS  Google Scholar 

  11. Merck & Co. Merck announces full-year and fourth-quarter 2012 financial results. 2012.

  12. Winrow CJ, Gotter AL, Cox CD, et al. Promotion of sleep by suvorexant: a novel dual orexin receptor antagonist. J Neurogenet. 2011;25(1–2):52–61.

    Article  PubMed  CAS  Google Scholar 

  13. US Food and Drug Administration. Suvorexant Advisory Committee Meeting briefing document. 2013. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/peripheralandcentralnervoussystemdrugsadvisorycommittee/ucm352970.pdf. Accessed 9 Sep 2014.

  14. Sun H, Kennedy D, Lewis N, et al. The single dose pharmacokinetic (PK) and pharmacodynamic (PD) profiles of suvorexant (MK-4305), a dual orexin receptor antagonist, in healthy male subjects [abstract no. PI-59]. Clin Pharmacol Ther. 2012;91(Suppl 1):S29.

    Google Scholar 

  15. Sun H, Kennedy WP, Wilbraham D, et al. Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men. Sleep. 2013;36(2):259–67.

    PubMed  PubMed Central  Google Scholar 

  16. Sun H, Yee KL, Khalilieh S, et al. Phase 1 safety, pharmacokinetics, and pharmacodynamics of the orexin receptor antagonist suvorexant administered with alcohol or paroxetine [abstract no. 0650]. Sleep. 2013;36(Suppl):A224.

    Google Scholar 

  17. Herring WJ, Ivgy-May N, Connor KM, et al. Effect of suvorexant, an orexin receptor antagonist, on patient-reported outcomes in patients with primary insomnia: integrated results from two phase-3 trials [abstract no. 0648]. Sleep. 2013;36(Suppl):A223.

    Google Scholar 

  18. Hisada S, Kikuchi M, Takahashi K, et al. Efficacy and safety of suvorexant, an orexin receptor antagonist, in patients with primary insomnia: a 3-month phase III study (P028) [abstract no. 0649]. Sleep. 2013;36(Suppl):A224.

    Google Scholar 

  19. Connor KM, Matzura-Wolfe D, Zhang Y, et al. Safety of suvorexant, an orexin receptor antagonist, in patients with primary insomnia: integrated phase 3 results [abstract no. 0647]. Sleep. 2013;36(Suppl):A223.

    Google Scholar 

  20. Vermeeren A, Vuurman E, Van Oers A, et al. Effects of suvorexant, an orexin receptor antagonist, on next day driving performance in healthy volunteers [abstract no. W11]. In: 51st Annual Meeting of the American College of Neuropsychopharmacology; 2–6 Dec 2012; Hollywood (FL).

  21. Uemura N, McCrea J, Sun H, et al. Effects of supratherapeutic and therapeutic doses of the orexin receptor antagonist suvorexant on respiration during sleep in healthy subjects [abstract no. 0645]. Sleep. 2013;36(Suppl):A222.

    Google Scholar 

  22. Troyer M, Uemura N, McCrea J, et al. Respiratory safety of the orexin receptor antagonist suvorexant during sleep in patients with compromised respiratory function and in healthy subjects [abstract no. P5.293]. Neurology. 2014;82(10 Suppl 1).

Download references

Disclosure

The preparation of this report was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. L. P. H. Yang is a contracted employee of Adis, Springer SBM.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Lily P. H. Yang

Authors
  1. Lily P. H. Yang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Lily P. H. Yang.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Yang, L.P.H. Suvorexant: First Global Approval. Drugs 74, 1817–1822 (2014). https://doi.org/10.1007/s40265-014-0294-5

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-014-0294-5

Keywords

Search

Navigation