Vanda Pharmaceuticals Announced The Publication Of An Article Titled "Melatonin Agonist Tasimelteon Improves Sleep In Patients With Primary Insomnia: A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial" In PLOS One, A Leading Open-Access Journal

Author: Benzinga Newsdesk | September 25, 2025 08:08am

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced the publication of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial" in PLOS One, a leading open-access journal.1

In the study, published on September 24, 2025 in PLOS One, HETLIOZ® met its primary endpoint, demonstrating a mean improvement in latency to persistent sleep (LPS) from baseline to the average of Nights 1 and 8 of 44.9 minutes (20 mg) and 46.3 minutes (50 mg) versus 28.2 minutes (placebo) (p < 0.001). Improvements in LPS persisted through the follow-up time points (Nights 22 and 29, p < 0.01). Additionally, HETLIOZ® use was not associated with cognitive or mood changes, and neither rebound nor withdrawal effects were observed after discontinuation.1 For access to the full study, visit DOI: https://doi.org/10.1371/journal.pone.0332366.

Insomnia, which affects over 10% of the American population and causes significant morbidity and next day consequences, remains a significant health problem for Americans.2,3

HETLIOZ® is a melatonin receptor agonist and circadian regulator that is approved for the treatment of Non-24-Hour Sleep-Wake Disorder in adults and for the treatment of nighttime sleep disturbances in adults and children with Smith-Magenis Syndrome. Vanda is continuing to pursue U.S. Food and Drug Administation (FDA) approval for HETLIOZ® in the treatment of insomnia and Jet Lag Disorder and is continuing to develop HETLIOZ® for the treatment of several other sleep disorders including Delayed Sleep Phase Disorder (DSPD) and pediatric insomnia.

References:

1. Synnott NC, Polymeropoulos CM, Xiao C, Birznieks G, Polymeropoulos MH (2025) Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial. PLOS ONE 20(9): e0332366. https://doi.org/10.1371/journal.pone.0332366
2. Institute of Medicine (US) Committee on Sleep Medicine and Research. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Colten HR, Altevogt BM, editors. Washington (DC): National Academies Press (US). 2006.
3. Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7-10. pmid:17824495

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