Vanda Pharmaceuticals announces the publication in PLOS One of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial"
Vanda Pharmaceuticals (Nasdaq: VNDA) announced the publication of positive clinical trial results for HETLIOZ® in treating primary insomnia in PLOS One journal. The study demonstrated significant improvements in sleep latency, with patients showing mean improvements of 44.9 minutes (20mg dose) and 46.3 minutes (50mg dose) compared to 28.2 minutes for placebo (p < 0.001).
The improvements persisted through follow-up periods (Nights 22 and 29), and importantly, no cognitive or mood changes, rebound, or withdrawal effects were observed after discontinuation. HETLIOZ®, a melatonin receptor agonist, is currently pursuing FDA approval for insomnia and Jet Lag Disorder treatment, while also developing applications for other sleep disorders.
Vanda Pharmaceuticals (Nasdaq: VNDA) ha annunciato la pubblicazione di risultati clinici positivi per HETLIOZ® nel trattamento dell'insonnia primaria sul Journal PLOS One. lo studio ha mostrato miglioramenti significativi nella latenza del sonno, con miglioramenti medi di 44.9 minuti (dose 20 mg) e 46.3 minuti (50 mg) rispetto ai 28.2 minuti del placebo (p < 0.001).
I miglioramenti sono rimasti attraverso i periodi di follow-up (Notti 22 e 29), e soprattutto, nessun cambiamento cognitivo o dell'umore, rebound o effetti di astinenza sono stati osservati dopo l'interruzione. HETLIOZ®, un agonista dei recettori della melatonina, è attualmente in attesa di approvazione FDA per il trattamento dell'insonnia e del Jet Lag Disorder, e sta sviluppando applicazioni per altri disturbi del sonno.
Vanda Pharmaceuticals (Nasdaq: VNDA) anunció la publicación de resultados clínicos positivos para HETLIOZ® en el tratamiento del insomnio primario en la revista PLOS One. El estudio mostró mejoras significativas en la latencia del sueño, con mejoras medias de 44.9 minutos (dosis 20 mg) y 46.3 minutos (dosis 50 mg) frente a 28.2 minutos para placebo (p < 0.001).
Las mejoras se mantuvieron durante los periodos de seguimiento (Noches 22 y 29) y, lo más importante, no se observaron cambios cognitivos o de ánimo, rebote ni efectos de retirada tras la discontinuación. HETLIOZ®, un agonista de los receptores de melatonina, actualmente busca la aprobación de la FDA para el tratamiento del insomnio y del Jet Lag Disorder, mientras también desarrolla aplicaciones para otros trastornos del sueño.
밴다 제약(나스닥: VNDA)은 PLOS One 저널에 HETLIOZ®의 불면증 1차 치료에 대한 긍정적 임상시험 결과를 발표했다. 연구는 수면 시작 지연에 있어 유의미한 개선을 보였으며, 20mg 용량에서 평균 44.9분, 50mg 용량에서 46.3분의 개선이 나타났고 위약 대비 28.2분(p < 0.001).
개선은 추적 기간(야간 22 및 29)까지 지속되었고, 특히 인지 또는 기분 변화, 반등 또는 중단 시 금단 현상이 관찰되지 않았다. 멜라토닌 수용체 작용제인 HETLIOZ®은 현재 불면증 및 시차 장애 치료를 위한 FDA 승인을 목표로 하며, 다른 수면 장애에 대한 적용도 개발 중이다.
Vanda Pharmaceuticals (Nasdaq: VNDA) a annoncé la publication de résultats positifs d’essais cliniques pour HETLIOZ® dans le traitement de l’insomnie primaire dans la revue PLOS One. L’étude a démontré des améliorations importantes de la latence d’endormissement, avec des améliorations moyennes de 44,9 minutes (dose 20 mg) et 46,3 minutes (dose 50 mg) par rapport à 28,2 minutes pour le placebo (p < 0,001).
Les améliorations se sont maintenues lors des périodes de suivi (nuits 22 et 29) et, surtout, aucun changement cognitif ou d’humeur, rebond ni effets de sevrage n’ont été observés après l’arrêt du traitement. HETLIOZ®, un agoniste des récepteurs de la mélatonine, est actuellement en cours d’approbation par la FDA pour le traitement de l’insomnie et du trouble du décalage horaire, tout en développant des applications pour d’autres troubles du sommeil.
Vanda Pharmaceuticals (NYSE: VNDA) kündigte die Veröffentlichung positiver klinischer Studienergebnisse für HETLIOZ® bei der Behandlung von primärer Schlaflosigkeit in der PLOS One-Zeitschrift an. Die Studie zeigte signifikante Verbesserungen bei der Schlaflatenz, wobei Patienten im Durchschnitt um 44,9 Minuten (20 mg-Dosis) bzw. 46,3 Minuten (50 mg-Dosis) besser abschnitten als Placebo (28,2 Minuten, p < 0,001).
Die Verbesserungen hielten sich über die Follow-up-Perioden (Nächte 22 und 29), und wichtig wurden nach Absetzen keine kognitiven oder stimmungsbezogenen Veränderungen, Rebound oder Entzugseffekte beobachtet. HETLIOZ®, ein Melatoninrezeptor-Agonist, strebt derzeit eine FDA-Zulassung für die Behandlung von Insomnie und Jet-Lag-Störung an und entwickelt auch Anwendungen für andere Schlafstörungen.
شركة فاندا للأدوية (ناسدك: VNDA) أعلنت عن نشر نتائج إكلينيكية إيجابية لـ HETLIOZ® في علاج الأرق الأساسي في مجلة PLOS One. أظهرت الدراسة تحسينات كبيرة في زمن البداية للنوم، حيث أظهرت الجرعة 20 mg تحسناً متوسطاً قدره 44.9 دقيقة و46.3 دقيقة للجرعة 50 mg مقارنةً بالدواء الوهمي 28.2 دقيقة (p < 0.001).
استمرت التحسينات عبر فترات المتابعة (الليالي 22 و29)، والأهم من ذلك، لم يُلاحظ أي تغير إدراكي أو مزاجي، أو ارتداد، أو أعراض انسحاب بعد التوقف عن العلاج. HETLIOZ®، وهو منبه مستقبلات الميلاتونين، يسعى حالياً للحصول على موافقة FDA لعلاج الأرق واضطرابJet Lag، كما يعمل أيضاً على تطوير تطبيقات لاضطرابات نوم أخرى.
Vanda Pharmaceuticals（纳斯达克股票代码：VNDA）宣布在 PLOS One 期刊发表了 HETLIOZ® 用于治疗原发性失眠的积极临床试验结果。研究显示睡眠潜时显著改善，20mg 剂量平均改善 44.9 分钟，50mg 剂量为 46.3 分钟，相较于安慰剂的 28.2 分钟（p < 0.001）。
这些改善在随访期（第22夜和第29夜）仍然存在，重要的是，在停止使用后，未观察到认知或情绪变化、反跳或戒断效应。HETLIOZ® 是一种褪黑激素受体激动剂，目前正寻求 FDA 对失眠和时差障碍治疗的批准，同时也在开发其他睡眠障碍的应用。
- Clinical trial met primary endpoint with statistically significant improvement in sleep latency (p < 0.001)
- No cognitive or mood changes, rebound, or withdrawal effects observed
- Results showed sustained improvement through follow-up period
- Potential expansion of HETLIOZ® indications to include insomnia, affecting over 10% of Americans
- FDA approval for insomnia treatment still pending
- Multiple competing indications under development may extend regulatory timeline
Insights
Vanda's HETLIOZ shows significant efficacy in insomnia clinical trial, expanding potential market and revenue opportunities beyond current approvals.
The newly published clinical trial results for HETLIOZ® (tasimelteon) demonstrate significant clinical efficacy in treating primary insomnia. The drug showed meaningful improvements in latency to persistent sleep (LPS) - reducing the time to fall asleep by 44.9 minutes (20mg) and 46.3 minutes (50mg) compared to 28.2 minutes with placebo (p<0.001). Importantly, these benefits persisted through follow-up periods (Nights 22 and 29).
What makes these results particularly noteworthy is the clean safety profile - no cognitive or mood disturbances and no rebound or withdrawal effects after discontinuation. This favorable safety profile differentiates HETLIOZ® from many existing insomnia treatments that often come with significant side effects or dependency concerns.
The insomnia market represents a substantial commercial opportunity, with over 10% of Americans affected. This indication would significantly expand HETLIOZ®'s potential market beyond its current approved uses for Non-24-Hour Sleep-Wake Disorder and Smith-Magenis Syndrome - both relatively rare conditions.
Vanda appears to be executing a strategic pipeline expansion for HETLIOZ®, pursuing multiple sleep disorder indications including insomnia, Jet Lag Disorder, Delayed Sleep Phase Disorder, and pediatric insomnia. This publication in a peer-reviewed journal strengthens Vanda's regulatory position as it seeks FDA approval for the insomnia indication.
The positive efficacy data coupled with the clean safety profile positions HETLIOZ® as a potentially differentiated option in the competitive but lucrative insomnia treatment market, which could drive meaningful revenue growth if approved.
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
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
References:
- 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
- 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. - Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7-10. pmid:17824495
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
About HETLIOZ®
For full
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not limited to statements regarding Vanda's pursuit of FDA approval of HETLIOZ® in the treatment of insomnia and Jet Lag Disorder and Vanda's clinical development plans for HETLIOZ® in the treatment of other sleep disorders, including DSPD and pediatric insomnia, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to receive a hearing with the FDA regarding the Company's supplemental New Drug Application (sNDA) for HETLIOZ® in the treatment of insomnia and Vanda's ability to obtain FDA approval thereof, the outcome of the FDA's further review of the supplemental New Drug Application (sNDA) for HETLIOZ® in the treatment of Jet Lag Disorder, and Vanda's ability to complete the clinical development and obtain FDA approval of HETLIOZ® for the treatment of DSPD, pediatric insomnia and other sleep disorders. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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