Sleep Month in Review: December 2024

Sleep Month in Review: December 2024

Last month brought noteworthy updates and findings in sleep medicine, from a US Food and Drug Administration (FDA) approval in obstructive sleep apnea (OSA) to new findings in sleep medicine across various specialties, including psychiatry, dermatology, migraine, and hepatology.

Tirzepatide (Zepbound) emerged as the first medication for obesity-related obstructive sleep apnea (OSA), and the FDA also authorized the Dreem 3S wearable for in-home sleep monitoring, enhancing algorithm updates for improved accuracy. This Month in Review captures insightful sleep medicine research published in December.

FDA Updates for Sleep Medicine

FDA Approves Tirzepatide for Obstructive Sleep Apnea in Obesity

The FDA has approved tirzepatide as the first and only prescription medication for adults with moderate-to-severe OSA and obesity. Eli Lilly and Company announced on December 20, 2024, that tirzepatide for adults with OSA demonstrated up to 20% weight loss and a significant reduction in breathing disruptions during sleep.

Among patients not using positive airway pressure therapy, tirzepatide led to 25 fewer hourly breathing disruptions compared with 5 for the placebo cohort. The treatment also led to remission or mild OSA symptoms in nearly half of patients. Combining weight loss and OSA improvement, tirzepatide offers new hope for patients with obesity and OSA.

FDA Authorizes Predetermined Change Control Plan for Sleep Wearable Dreem 3S

The FDA has authorized a Predetermined Change Control Plan (PCCP) for the Dreem 3S sleep wearable, allowing Beacon Biosignals to update its sleep staging algorithm without new 510(k) submissions. Dreem 3S, a lightweight EEG headband, enables in-home sleep monitoring with accuracy comparable to human experts, offering an alternative to in-lab polysomnography.

Equipped with dry EEG electrodes and an accelerometer, the device records sleep patterns for 24 hours and supports therapy development for CNS disorders. The PCCP approval facilitates rapid algorithm enhancements, ensuring greater accuracy and reliability while advancing sleep disorder insights.

Sleep Expert Writes about New RLS Guidelines

Changes in Restless Legs Syndrome Treatment Recommendations

The American Academy of Sleep Medicine has updated Restless Legs Syndrome (RLS) treatment guidelines, advising against dopamine agonists as a first-line option due to risks of symptom augmentation and impulse control disorders. Long-term dopamine agonist use can exacerbate symptoms, leading to earlier onset and spread beyond the legs. Updated guidelines emphasize checking iron levels, recommending intravenous or oral iron for deficiencies. Alpha-2-delta calcium channel ligands, such as gabapentin and pregabalin, are now strongly recommended, offering effective alternatives to improve RLS symptoms and sleep quality.

Related: https://www.hcplive.com/view/aasm-updates-clinical-guidelines-restless-legs-syndrome

Sleep Medicine Findings in Atopic Dermatitis, MASLD Development, & More

Parents of Children with Atopic Dermatitis Often Sleep Less Than 7 Hours

A study using data from the National Health Interview Survey found that parents of children with atopic dermatitis are more likely to get < 7 hours of sleep and use sleep medications. Of parents with children diagnosed with atopic dermatitis, 45.2% slept less than the recommended 7 hours, and 13.3% took medications to help with sleep. In comparison, 37.1% of parents without children with atopic dermatitis had insufficient sleep, and 9.9% used sleep medications. These findings highlight the significant indirect burden of pediatric atopic dermatitis on parents' sleep health.

High Prevalence of RLS Found in Patients with MDD, Migraine, Anxiety

A study of 600 psychiatric patients revealed a high prevalence of RLS, with 41.2% of participants affected. Major depressive disorder (MDD), migraine, and anxiety disorders were particularly associated with RLS, with prevalences of 42.9%, 19.4%, and 50%, respectively.

RLS significantly impacted sleep quality, causing difficulties in falling asleep, shorter sleep duration, and fragmented sleep. Despite its high prevalence, RLS remains underdiagnosed, and its relationship with mental health conditions emphasizes the importance of evaluating RLS in patients presenting with mood, migraine, or anxiety symptoms, as poor sleep exacerbates these psychiatric disorders.

Study Suggests Fragmented Nocturnal Sleep May Play a Role in MASLD Development

A study found that patients with metabolic dysfunction-associated steatotic liver disease (MASLD) experience significant fragmented nocturnal sleep. Despite similar sleep durations, MASLD patients reported shorter sleep and poorer quality, with psychological stress contributing to sleep disturbances. The study revealed that MASLD patients had more awakenings and lower sleep efficiency compared to healthy controls, nor did a sleep hygiene education session help sleep parameters.

Biggest Sleep Medicine News in 2024

Sleep Medicine Year in Review: 2024

The year 2024 brought significant advancements in sleep medicine, highlighted by FDA approvals and updated clinical guidelines. Tirzepatide was approved for obstructive sleep apnea in obesity, while sodium oxybate and pitolisant gained approval for pediatric narcolepsy, providing more treatment options.

The FDA also authorized updates to Dreem 3S, a sleep wearable. New guidelines for restless legs syndrome emphasized avoiding dopamine agonists and recommended iron therapies and alpha 2 delta ligands. Phase 2 data on KP1077 for idiopathic hypersomnia showed promising results, and experts discussed sleep health issues related to dialysis, long COVID, and daylight savings.