NIH Highlighted Topic: Sleep, Circadian Rhythms, and Substance Use Disorders
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is seeking innovative research proposals through the SBIR Program focused on the biological mechanisms linking sleep, circadian rhythms, and substance use disorders (SUDs). NIH is particularly interested in technologies and therapeutic approaches that improve understanding of how sleep dysregulation and circadian disruption contribute to addiction development, relapse risk, recovery outcomes, and long-term neurological health.
This highlighted topic encourages basic and pre-clinical research investigating the bidirectional relationship between sleep/circadian dysfunction and substance use disorders, including opioids, stimulants, nicotine, cannabinoids, designer drugs, and alcohol-related disorders. Companies developing neuroscience platforms, biomarkers, diagnostics, computational tools, imaging technologies, digital therapeutics, wearable monitoring systems, AI-enabled predictive models, or novel therapeutic interventions related to addiction and sleep science may be strong candidates for funding.
NIH is especially interested in projects utilizing behavioral, cognitive, cellular, molecular, genetic, imaging, pharmacological, and computational approaches to identify mechanisms, biomarkers, and therapeutic targets associated with addiction and circadian biology. Research exploring sex-specific responses, hormonal influences, and women’s health considerations is also encouraged.
Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.
This highlighted topic is supported primarily by the National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the Office of Research on Women’s Health (ORWH), all of which may give special consideration to high-impact applications advancing addiction science, sleep medicine, circadian biology, and precision behavioral health solutions.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of technologies and therapeutic approaches focused on sleep, circadian rhythms, addiction biology, and substance use disorder (SUD) prevention, treatment, and recovery.
Eligible activities may include:
Development of digital health platforms, wearable technologies, or remote monitoring systems for sleep and addiction management
AI, machine learning, or predictive analytics tools for identifying relapse risk or treatment response
Biomarker discovery related to sleep dysregulation, circadian disruption, and substance use disorders
Neuroscience research investigating reward pathways, neurotransmitter systems, and addiction-related brain circuitry
Imaging technologies and neurodiagnostic platforms for studying sleep and addiction interactions
Development of therapeutics targeting circadian rhythms, sleep quality, or addiction recovery outcomes
Research into opioid, stimulant, cannabinoid, nicotine, hallucinogen, and polysubstance-related sleep disruption
Behavioral and cognitive interventions designed to improve sleep and reduce relapse risk
Sex-specific and women’s health-focused research related to hormonal influences, pregnancy, menopause, and addiction recovery
Computational, molecular, cellular, and genetic modeling of sleep-addiction interactions
Preclinical validation, prototype development, translational studies, and regulatory preparation
Development of precision medicine or personalized treatment approaches for addiction and sleep disorders
Funding may also support personnel, software development, laboratory testing, clinical data analysis, prototype fabrication, intellectual property protection, commercialization planning, and other research and development activities necessary to advance a commercially viable solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
Triple your likelihood of success through proven strategy and insider-aligned proposal development
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Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.
