Vanda Pharmaceuticals Publishes Positive Phase 3 Insomnia Data for HETLIOZ® in PLOS ONE

Vanda Pharmaceuticals Publishes Positive Phase 3 Insomnia Data for HETLIOZ® in PLOS ONE

By, Admin 26 September 2025

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced the publication of new clinical data in PLOS ONE demonstrating that its melatonin receptor agonist HETLIOZ® (tasimelteon) significantly improved sleep outcomes in patients with primary insomnia.

Study Highlights

The multicenter, randomized, double-blind, placebo-controlled trial met its primary endpoint:

  • Latency to Persistent Sleep (LPS): Mean improvements of 44.9 minutes (20 mg) and 46.3 minutes (50 mg) versus 28.2 minutes (placebo) (p < 0.001).
  • Durability: Improvements persisted through Nights 22 and 29 (p < 0.01).
  • Safety: No cognitive or mood changes, and no rebound or withdrawal effects after discontinuation.

Addressing a Major Health Burden

Insomnia affects over 10% of Americans and is linked to impaired daily functioning and significant morbidity.

“HETLIOZ® is already FDA-approved for Non-24-Hour Sleep-Wake Disorder and Smith-Magenis Syndrome–related sleep disturbances. These data strengthen its potential in insomnia and other circadian-related conditions where unmet need remains high.”

  • Vanda spokesperson.

Expanding Development Path

Vanda is pursuing FDA approval for HETLIOZ® in insomnia and Jet Lag Disorder, while also advancing development in Delayed Sleep Phase Disorder (DSPD) and pediatric insomnia.

About HETLIOZ®

HETLIOZ® is a melatonin receptor agonist and circadian regulator. It is FDA-approved for:

  • Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
  • Nighttime sleep disturbances in adults and children with Smith-Magenis Syndrome

For full U.S. Prescribing Information,

About Vanda Pharmaceuticals

Vanda Pharmaceuticals Inc. is a global biopharmaceutical company developing and commercializing innovative therapies for high unmet medical needs.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!