A new clinical trial aims to explore the effects of Daridorexant, a dual orexin receptor antagonist, on several health outcomes, including insomnia, daytime alertness, and smoking cessation. The trial is sponsored by Legacy Health System and Washington State University, with recruitment status labeled as ‘Not yet recruiting’ on January 10, 2026.
This study is particularly relevant to clinicians and regulatory professionals interested in multi-system therapeutic applications that address both substance use disorders and sleep health. Given the growing intersection of these conditions, the outcomes of this research could pave the way for new integrated treatment approaches.
What is the focus of this study?
The trial investigates Daridorexant (50 mg) for its potential to improve three key outcomes: sleep quality, daytime alertness, and reduction in smoking behaviors. Daridorexant is primarily indicated for insomnia, classified under dual orexin receptor antagonists (DORAs). This research marks an effort to explore its secondary applications on tobacco and nicotine addiction, which often presents comorbidly with sleep disorders.
The study serves an important dual purpose: understanding Daridorexant’s direct effects on cognition and sleep recovery, while investigating whether improved rest may lessen nicotine withdrawal symptoms and cravings. Placebo controls will also be used for efficacy comparisons.
How will the trial be conducted?
As of the publication date, the project is listed as ‘Not yet recruiting.’ According to ClinicalTrials.gov, eligible individuals may include adults experiencing both insomnia and active nicotine or tobacco use, signaling an intersectional approach to inclusion criteria. The methodology will likely focus on robust clinical endpoints, including validated scales for measuring sleep quality, daytime alertness, and dependency markers for nicotine addiction.
The sponsors of the study, Legacy Health System and Washington State University, bring depth to both healthcare delivery systems and academic research designs, likely strengthening the trial’s setting and execution. Given the scope of work, an emphasis on safety monitoring will parallel the efficacy-focused investigation, aligning with MDR-compliant safety assessments under regulatory conditions.
What are the potential clinical implications?
If successful, this trial could redefine how clinicians use pharmacological interventions to manage comorbidities between substance use disorders and sleep health. Daridorexant could become an alternative to current smoking cessation methods by addressing nicotine-related sleep disturbances, which are often overlooked in cessation programs.
Moreover, this study contributes to growing evidence for how orexin pathways interact with addiction and dependence mechanisms, potentially opening avenues for further regulatory clearances or expanded indications for Daridorexant. The findings may also support integrated care approaches, combining behavioral and pharmacologic strategies against nicotine addiction.
Professionals tracking these developments should consider the implications for formulary decisions and updated therapeutic guidelines for comorbid insomnia and substance use disorders.
Frequently Asked Questions (FAQ)
- What is Daridorexant?
It is a dual orexin receptor antagonist approved for treating insomnia. - How is this trial different from standard Daridorexant research?
This trial expands the focus to study additional impacts on daytime alertness and smoking behaviors. - What conditions are targeted in the study?
The study focuses on insomnia, nicotine dependence, tobacco use, and broader substance use disorders. - Who is sponsoring the research?
The study is sponsored by Legacy Health System and Washington State University. - Can clinicians apply for updates on the trial?
Clinicians can access trial specifics through the ClinicalTrials.gov listing linked below.
Conclusion
This upcoming study on Daridorexant has the potential to transform how providers manage the co-occurrence of sleep disorders and nicotine addiction. By targeting orexin pathways, the research could contribute to novel approaches to address withdrawal, cravings, and insomnia in tandem. Professionals in regulatory, clinical, and therapeutic development fields will likely find the results informative for broader healthcare innovations.
Disclaimer
This article is for informational purposes only. It does not constitute legal or regulatory advice. Healthcare professionals should consult applicable guidelines and clinical evidence when making treatment decisions.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07328594?term=medical+device