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Tasimelteon: A Review in Non-24-Hour Sleep-Wake Disorder in Totally Blind Individuals

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Abstract

Tasimelteon (Hetlioz®) is a dual melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) (free-running disorder). In two randomized, double-masked, multicentre, phase III trials, totally blind individuals with Non-24 who received oral tasimelteon 20 mg once nightly were significantly more likely than those receiving placebo to entrain the circadian pacemaker (the SET trial) and maintain entrainment (the RESET trial). Sleep/wake parameters and functioning were also improved with tasimelteon. Oral tasimelteon was generally well tolerated in totally blind patients with Non-24. In conclusion, tasimelteon is a useful drug for the treatment of Non-24 in totally blind individuals.

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Acknowledgments

During the peer review process, the manufacturer of tasimelteon was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Authors and Affiliations

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

    Gillian M. Keating

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  1. Gillian M. Keating
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Correspondence to Gillian M. Keating.

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Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

Gillian Keating is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: C.I. Eastman, Biological Rhythms Research Laboratory, Department of Behavioral Sciences, Rush University Medical Center, Chicago, IL, USA; I. Fietze, Center of Sleep Medicine, Charité–Universitätsmedizin Berlin, Berlin, Germany; T.J. Swick, Department of Neurology, University of Texas School of Medicine-Houston, Houston, TX, USA; J.M. Zeitzer, Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.

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Keating, G.M. Tasimelteon: A Review in Non-24-Hour Sleep-Wake Disorder in Totally Blind Individuals. CNS Drugs 30, 461–468 (2016). https://doi.org/10.1007/s40263-016-0330-y

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