A significant number of U.S. adults struggle with sleep, with approximately one in three reporting short sleep duration and about one in ten meeting the criteria for chronic insomnia. As interest in sleep supplements rises, Americans invest billions annually in over-the-counter sleep aids, often without clear evidence on their effectiveness or safety.
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A new study, led by Richard Schwab, MD, and Michael Perlis, PhD, from Penn Medicine, aims to clarify which sleep medications work best for treating insomnia. This trial will compare five medications—trazodone, zolpidem (Ambien), doxepin, melatonin, and diphenhydramine (Benadryl)—against a placebo in over 1,000 patients from primary care practices within the University of Pennsylvania Health System.
Rather than focusing on a single drug in controlled laboratory settings, this study will utilize a comparative effectiveness research (CER) model to examine how the medications perform under real-world conditions, which is crucial since insomnia is often diagnosed and treated in primary care.
For participants who do not respond to the medications, the study will offer cognitive behavioral therapy for insomnia (CBT-I) at no cost. The research seeks to provide evidence-based guidelines for physicians and patients concerning insomnia treatments.
Perlis emphasized the need to determine which treatments are safest and most effective, stating, “For insomnia, the real question is where to start—what’s the best first step for the average patient who walks into their primary care doctor’s office saying they can’t sleep?” He noted the unique nature of the study in its size and real-world applicability.
Schwab highlighted that if none of the tested medications are effective, all participants will still have access to CBT-I, aimed at ultimately improving their sleep.
Insomnia often coexists with other health issues, necessitating a comprehensive approach to treatment. As Jeffrey Millstein, MD pointed out, insomnia frequently links to conditions such as depression and chronic pain. The findings of this study could enable primary care doctors to make quicker, evidence-based decisions during patient visits.
CBT-I, which focuses on structured behavioral changes to reset sleep patterns, is identified as the first-line treatment for chronic insomnia. Despite this, many patients initially prefer medication. The study seeks to identify the most suitable medicinal approaches based on safety and patient preference.
Funded by the Patient-Centered Outcomes Research Institute (PCORI), the project will ensure findings are effectively communicated to patients, doctors, and policymakers, enhancing understanding and implementation. Schwab noted that responses to the challenges in sleep medicine could significantly change how insomnia is treated.
For more information about the study or participation options, visit www.sleeplessinphilly.com.