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Sleeping Pills Receive FDA's Strongest Warning: Here's What You Need to Know

The FDA recently introduced a black box warning — the most prominent warning the agency can require — for commonly prescribed sleep medications due to rare but serious complex sleep behaviors that have been reported following use. These behaviors may include sleep walking, sleep driving, and engaging in other activities while not fully awake. Unfortunately, there is no way to predict who may experience these complex sleep behaviors. These behaviors may occur following first time or long term use and have been reported following low doses of medication.

The FDA black box warning is specific to the most common class of prescription sleep medications, referred to as “ Z-drugs,” which include eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist). In the last several decades, Z-drugs gained popularity due to desirable clinical properties compared to other available sleep medications, including shorter duration of action (e.g., clearing the system quicker so an individual is less likely to feel “hungover” upon awakening), reduced impact on sleep quality, and diminished residual daytime effects.

Despite the widespread use of Z-drugs, the benefits of these medications may actually be smaller than people expect. A 2012 meta-analysis demonstrated that when compared to placebo, Z-drugs resulted in falling asleep 22 minutes earlier on average, but didn’t have a significant impact on any other sleep problems. In addition to the risks covered by the FDA black box warning, more common Z-drug side effects include impaired cognitive functioning (e.g., memory loss), impaired motor functioning (e.g., falls), daytime fatigue, and increased tolerance and addiction, which is why Z-drugs aren’t generally recommended for long-term use (potential risks of Z-drug use are further covered here and here). Further, research has demonstrated that Z-drugs significantly increase the risk of opioid-related overdoses in the United States.

Importantly, there is another option for the treatment of insomnia — a type of therapy called cognitive behavioral therapy (CBT). A collaborative and goal-oriented form of psychotherapy, CBT is usually comprised of 6-8 in-person, weekly treatment sessions with a trained sleep medicine clinician. During these sessions, the clinician works with the individual to identify and change unhelpful thoughts and behaviors that are driving the insomnia, thereby improving the individual’s sleep. CBT is firmly rooted in science and the effectiveness of CBT has been well-established across dozens of clinical trials. Further, CBT has been shown to improve sleep across a range of ages, medical, and mental health conditions. Although CBT is designed to improve sleep, benefits have also been shown for mental and physical health and overall quality of life. In fact, the benefits of CBT are so compelling that the American College of Physicians recommends CBT as the first line of treatment for insomnia (as opposed to medication).

Despite the strong evidence for CBT and recommendations from the American College of Physicians, prescription sleep medications continue to dominate the insomnia treatment landscape. Part of the reason for this has to do with the fundamental qualities of sleep medications themselves. Prescription sleep medications are affordable, easy to use, and are widely available to people. In 2011 there were 9 million prescriptions filled in retail pharmacies for Ambien alone. Traditional CBT, on the other hand, is not as accessible or affordable. For example, not everybody has access to a clinician who can provide this type of treatment and insurance does not always cover psychotherapy.

Digital therapeutics — defined by the Digital Therapeutic Alliance as evidence-based interventions driven by high quality software programs to prevent, manage, or treat a range of physical, mental, and behavioral conditions — provide a potential solution to this problem. Digital therapeutics are able to bring the same appealing qualities of prescription medications (accessibility, ease of use, low end-user cost) to evidence-based psychotherapy by making these treatments available via mobile application and/or the web.

Sleepio is one example of a digital therapeutic program to address poor sleep. Sleepio is a fully automated, yet highly personalized program that is rooted in CBT and is available via mobile application and the web. Sleepio users interact with The Prof, their virtual sleep expert, who teaches them evidence-based skills via weekly video sessions. The benefits of Sleepio have been demonstrated in eight randomized controlled trials, in over 33 peer reviewed publications, and in over 12,000 participants.

Sleepio and other digital therapeutic programs may be the first true alternative to prescription medications as these programs are also affordable, accessible to millions of people, standardized, and have a strong evidence base.

As an added bonus, digital therapeutic programs don’t come with a black box warning from the FDA.

Topics: Digital medicine, Sleep, insomnia