Vanda Pharmaceuticals Inc. announced on September 25, 2025, the publication of an article in PLOS One detailing positive results from a multicenter, randomized, double-blind, placebo-controlled trial of HETLIOZ (tasimelteon) for primary insomnia. The study, published on September 24, 2025, demonstrated that HETLIOZ met its primary endpoint.
In the trial, HETLIOZ showed a mean improvement in latency to persistent sleep (LPS) from baseline to the average of Nights 1 and 8 of 44.9 minutes for the 20 mg dose and 46.3 minutes for the 50 mg dose, compared to 28.2 minutes for placebo (p < 0.001). These improvements in LPS persisted through follow-up time points at Nights 22 and 29 (p < 0.01).
The study also reported that HETLIOZ use was not associated with cognitive or mood changes, and no rebound or withdrawal effects were observed after discontinuation. Insomnia affects over 10% of the American population, representing a significant health problem. Vanda is continuing to pursue U.S. Food and Drug Administration approval for HETLIOZ in the treatment of insomnia, alongside its development for other sleep disorders.
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