In 2022, physicians in the sleep medicine field have experienced both progress and challenges. The insomnia care paradigm in particular saw treatment advances such aspharmacological therapy with the FDA approval of daridorexant (Quviviq; Idorisa), following the 2019 greenlight of lemborexant (Dayvigo; Eisai), as well as more data on cognitive behavioral therapy (CBT), which has become a recommended treatment for patients.

Challenges, though, persisted. Conversations about the impact of daylight saving time and its effect on patients’ sleep health were ongoing, as were those focused on school start times and pediatric sleep. Another major challenge that has been reported in the literature that needs more research is substance use, which has been shown to have significant effects on sleep. 

Overall, in conversations with NeurologyLive® over the course of this year, sleep medicine physicians indicated that the future of sleep care for conditions like insomnia appears to be moving toward a digital approach with artificial intelligence (AI), digital CBT, and wearable devices. This future holds much hope for those caring for patients, even with the various challenges that lie ahead. Ultimately, a better scientific understanding of sleep’s overall effects on health and an exacerbation of sleep conditions by societal issues has brought sleep health to the forefront of population health conversations.

New Treatments for Insomnia

One of the most recently approved therapies for insomnia is daridorexant, which got the FDA go-ahead on January 7, 2022. Shortly after the approval, Thomas Roth, PhD, the director of the Sleep Disorders and Research Center at Henry Ford Hospital, and an investigator in the clinical development studies of the newly approved Idorsia therapy, offered theclinician perspective on the efficacy and safety profiles from the study as well ashis other takeaways.

On the day of the decision, he noted in a statement that contextually it is important to remember that insomnia “is not only a problem of the night, but affects a patient’s ability to function during the day,” adding that, “elevating the [awareness about the] impact insomnia has on both the night and day remains critical in addressing patients’ needs.”

Martine Clozel, MD, the chief scientific officer at Idorsia, also said in a statement,¹ that the companydesigned daridorexantwith the goal of “help[ing] address several issues people with insomnia face. Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects."

Another therapy that was approved and continues to be beneficial for individuals with insomnia is lembroexant. A recent study from the post-hoc analysis of Study 303 (NCT02952820) demonstrated that those who had clinically meaningful reductions on Insomnia Severity Index (ISI) scores reported greater changes from baseline in several outcome measures. The treatment was approved in 2019 for insomnia and has been used in different analyses studies since then. The Study 303 analysis suggested that most patients on lembroexant experience a positive medication effect.

In recent years, treating sleep disorders including insomnia with CBThas become a recommended approach, but there have been challenges in increasing its use. Yuri Maricich, MD, MBA, an internal medicine physician, and chief medical officer and head of development at Pear Therapeutics, recently published data along with a group of investigators froma real-world cohort of individuals that utilized a digital therapeutic called Somryst (previously known as SHUTi) which evaluates healthcare resource utilization, associated costs, and insomnia severity effects of the therapy.^2,3

“There’s been a lot of work looking at the importance of—and what is addressed in the clinical guidelines—cognitive behavioral therapy for insomnia, but unfortunately, the vast majority of patients can’t get access [to it] because there are only 600 clinicians who are trained, and less than 400 who are even certified,” Maricich told NeurologyLive® in an interview where he shared his perspectives on the motivations for the real-world use of CBT interventions. 

Similarly, Michelle Chen, PhD, a neuropsychologist at Rutgers University and core member at the Institute for Health at Rutgers, told NeurologyLive® that CBT is the gold standard for treating insomnia. She noted that its effectiveness lies in part because it teaches patients what the best habits are to promote good sleep—not necessarily changing the brain chemistry of the patient. Additionally, it lacks as many adverse effects as pharmacologic medications.

Additionally, another nonpharmacological approach that has become more widespread recently in clinical care is the incorporation of AI. The use of AI technology in sleep medicine has assisted with improving the labor-intensive acts of monitoring and scoring sleep stages. One such AI effort is being spearheaded by the American Academy of Sleep Medicine (AASM), which has established a 2-year pilot program called the AI/Autoscoring Certification Program that will focus on polysomnograms for sleep stage scoring and whether the software demonstrates equivalent or better accuracy than manual scoring.

Anuja Bandyopadhyay, MD, an assistant professor of clinical pediatrics at Indiana University School of Medicine, and the chair of the AASM’s Artificial Intelligence in Sleep Medicine Committee, spoke with NeurologyLive® about her perspective on the state of understanding insomnia, and how better phenotype-specific treatment can improve care. “We didn’t really realize that there could be different phenotypes, different clinical expressions of the same disease. So, a person with sleep apnea and insomnia is very different from a person with depression and insomnia, not just in the clinical expression, but in how they respond to different medications,” Bandyopadhyay said.

Other types of nonpharmacological interventions for insomnia include listening to music. One example from research this year comes from a review of randomized controlled trials. The updated review showed thatmusic potentially can be an effective approach for the improvement of subjective sleep quality for adults that experience insomnia symptoms.⁴ Listening to music has been known to be used as a sleeping aid and can be an effective nonpharmacological intervention for improving insomnia symptoms in adults, according to the review.

Lead investigator Kira Jespersen, PhD, MSc, an assistant professor in the Center for Music in the Brain and the Department of Clinical Medicine at Aarhus University & The Royal Academy of Music Aarhus/Aalborg, in Aarhus, Denmark, and colleagues wrote, “Listening to music may improve slightly sleep‐onset latency (how quickly a person falls asleep), sleep duration (length of time a person is asleep) and sleep efficiency (amount of a time a person is asleep compared to the total time spent in bed), compared to no treatment or treatment as usual. None of the studies reported any negative effects caused by listening to music.”

Circadian Rhythm

School start times have been another hot topic in sleep and have been shown to have an impact on pediatric circadian rhythms. These unhealthy sleep patterns can carry on from childhood into adulthood. And although sleep disorders may be common in some children and adolescents influenced by lifestyle behaviors, others could be from the cause of a neurological condition, making their recognition imperative. Carol Rosen, MD, a professor of pediatrics at Case Western University, has concerns about the transition period before school begins, when children start going to bed earlier and adjusting their internal clock.

"Figure out what the schedule is, how much sleep your child needs, and kind of work backwards. Maybe go back in 15- or 30-minute increments, starting with your wakeup time. Move that back," Rosensaid in an interview with NeurologyLive® where she shared the advice she’s given to parents.

Chris Winter, MD, owner of Charlottesville Neurology and Sleep Medicine clinic and CNSM Consulting, and an author of several books on sleep, also shared his perspective on pediatric sleep on the Mindful Moments® podcast. He summarized the state of pediatric sleep disorders and provided some thoughts on the current system of schooling and how it impacts the sleep health of children along. He also expanded on the current trends in sleep medicine research, and what issues—such as recognition of sleep disorders—need to be addressed.

Children that experience poor sleep may also have their moods impacted as well. "When you’re cranky, it affects emotional regulation," Jodi Mindell, PhD, told NeurologyLive®. “How can you keep it together? Do you get angry much more easily? Do you burst out into tears? Do you start laughing and can’t control it? The kid whose super silly in school may be because they can’t regulate their emotions because they’re not getting enough sleep."Mindell, a psychologist in the Department of Child Adolescent Psychiatry and Behavioral Sciences, and the associate director of the Sleep Center at the Children’s Hospital of Philadelphia (CHOP), explained that there are 5 main domains of sleep-related issues in children and adolescents: mood, cognition, behavior, health, and families.

Seema Khosla, MD, FCCP, FAASM, the medical director of the North Dakota Center for Sleep, was also interviewed by NeurologyLive®, for the Mindful Moments® podcast, about the AASM’s current stance on another societal effect on sleep health—and not just on children, but adults as well—daylight saving time. Kholsa offered insight into the academy’s ongoing initiative to switch to a fixed standard time year-round and provided an expert opinion on how it might help address the impact on circadian rhythm.

Earlier in the year, the Sunshine Protection Act was passed by the US Senate, legislation that would make daylight saving time permanent starting in 2023. In response to the bill, the AASM released a statement further expressing its gratitude to the Senate. Although, the AASM also advised the House of Representatives to take more time in assessing the potential ramifications of establishing this permanent daylight savings time, and plan for the future with health in mind.

Lingering Challenges

Another ongoing point of discussion was the effects of various substances on sleep health, including alcohol and cannabis, among others. Based on recent research this year, the frequency of alcohol and cannabis use may be strongly associated with insomnia-related symptoms from poor sleep quality. Investigator Wendy Troxel, PhD, a senior behavioral scientist at the RAND Corporation,told NeurologyLive®that, according to her observed research, “We found in looking at longitudinal profiles of sleep that having poor sleep quality alone or in combination with other dimensions of disrupted sleep was associated with higher frequency of alcohol use at baseline and greater increases in alcohol use over time, as compared to other sleep profiles with good sleep quality.”

Among these concerns are still some lingering challenges when it comes to the treatment of insomnia. Despite progress, there are a few nonpharmacological interventions available. Other recommendations for patients to improve their sleep health include incorporating positive lifestyle changes that may alleviate symptoms suchas changingthe sleep area or schedule, avoiding big meals and alcohol before bed, and staying active—but implementing behavioral changes often prove difficult in practice. However, if behavioral interventionsare ineffective method for the patient experiencing insomnia, then the pharmacological treatments may provide a better route for patients to take.

Ashgan A. Elshinawy, DO, a pulmonologist at Penn Medicine, believes that from both the clinician and patient perspectives, patience is the most important aspect of care. Elshinawy discussed some of the present challengesin caring for patients with insomniaduring an interview with NeurologyLive®,and mentioned some of the biggest priorities for the future with improving the paradigm.

COVID-19 has been anotherfactor impacting individuals with insomnia as the pandemic has been associated with an increase in symptoms of insomnia based on prior research from this year. Lead author of an investigational analysis on the topic, Maha Meshal Alrasheed, PhD, MSc, an associate professor in the Clinical Pharmacy Department at the College of Pharmacy of King Saud University, wrote that their data, “suggests that the COVID-19 pandemic is associated specifically with a marked increase in the rates of subthreshold insomnia symptoms but not moderate or severe insomnia.”

Alrasheed and colleagues found statistically significant differences between countries for all severities of insomnia symptoms in their assessment. Notably, neither age nor sex appeared to be moderators of the cumulative prevalence of subthreshold insomnia symptoms or of clinically significant insomnia.

“Over the past couple years, in the wake of the COVID-19 pandemic, sleep in general is having a moment.Insomnia specificallydefinitely has grown in the public awareness of what a problem it is. Insomnia rates were rising considerably during the pandemic, particularly during the stay-at home orders, really raising the salience of sleep problems, across the population. From young people to old people, many people, even more so than before, are aware of it,” Troxel told NeurologyLive®. She added that insomnia has been the most common sleep disorder for quite some time, affecting more than 50 million adults in the United States alone.

Troxel noted that the future is bright, though. Growth in awareness often lends itself to progress in research, and Troxel explained that progress has been made in the development of interventions not only at the individual level but the community level. The work of the AASM and other organizations has begun to lead to policy decisions and changes, making sleep health a priority at a population health level. All in all, it points to a growth in understanding about sleep’s impact on general health and comorbidity—and as one improves, so does the other. “I think, resolving any sleep issues or trying to help patients sleep better, for most conditions, usually would lead to better functioning because sleep is so important. If you have poor sleep, it's hard for people to be productive. It can often exacerbate a lot of other conditions and other symptoms such as fatigue, cognition, mood, and so on,” Chen said.

References

<sup>1. Idorsia receives US FDA approval of Quiviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. News release. Idorsia. January 10, 2022. Accessed January 10, 2022. https://www.biospace.com/article/releases/idorsia-receives-us-fda-approval-of-quviviq-daridorexant-25-and-50-mg-for-the-treatment-of-adults-with-insomnia/?s=85
2. Forma F, Knight TG, Thorndike FP, et al. Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia. Clinicoecon Outcomes Res. 2022;14:537-546. doi:10.2147/CEOR.S368780
3. Pear Therapeutics Announces Publication of New Analysis of Real-World Data Showing Reduction in Insomnia Severity, Healthcare Resource Utilization and Associated Costs in Adults Using Somryst®. News release. Pear Therapeutics. August 10, 2022. Accessed August 25, 2022. https://peartherapeutics.com/pear-therapeutics-announces-publication-of-new-analysis-of-real-world-data-showing-reduction-in-insomnia-severity-healthcare-resource-utilization-and-associated-costs-in-adults-using-somryst/
4. Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022;8(8):CD010459. Published 2022 Aug 24. doi:10.1002/14651858.CD010459.pub3</sup>