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Suvorexant: First Global Approval

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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.

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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.

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

    Lily P. H. Yang

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  1. Lily P. H. Yang
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Correspondence to Lily P. H. Yang.

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

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Yang, L.P.H. Suvorexant: First Global Approval. Drugs74,1817–1822 (2014). https://doi.org/10.1007/s40265-014-0294-5

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