Central hypersomnias are equally prevalent in men and women, but sleep apnea, “perhaps the most common cause of EDS overall,” is more common in men than women, according to St. Louis. He added that sleep apnea may present differently in women who generally show less EDS and more fatigue-related symptoms at presentation.

Treatment

For OSA, a common treatment is continuous positive airway pressure (CPAP) therapy, which relieves airway obstruction and improves sleep continuity, according to St. Louis. For central hypersomnolence disorders — like narcolepsy and idiopathic hypersomnia — therapeutic options include stimulants and wake-promoting medications. Of note, however, sometimes prescribed/strategic napping is enough to relieve symptoms.

St. Louis noted two novel wake-promoting medications for narcolepsy and hypersomnolence accompanying sleep apnea: Sunosi (solriamfetol, Axsome Therapeutics) and Wakix (pitolisant , Harmony Biosciences), a histamine-promoting medication.

In 2019, the FDA approved solriamfetol, the first dual-acting dopamine and norepinephrine reuptake inhibitor, to treat EDS associated with narcolepsy or obstructive sleep apnea. Phase 3 data showed that solriamfetol significantly increased wakefulness and reduced sleepiness with mostly mild or moderate adverse events in patients with OSA and EDS.

A study published in 2020 showed that treatment with pitolisant decreased excessive daytime sleepiness and improved several other outcomes when compared with placebo in patients with OSA who refuse CPAP. In addition, in early 2023, Aculys Pharma Inc. announced the start of a phase 3 trial of pitolisant in patients with EDS associated with OSA syndrome.

St. Louis also discussed oxybate medications, a novel treatment given at night to promote deeper sleep and better sleep quality, which can restore daytime alertness in narcolepsy and idiopathic hypersomnia.

In 2022, the FDA granted tentative approval to Lumryz (sodium oxybate, Avadel Pharmaceuticals), a once-at-bedtime oral treatment for EDS or cataplexy in adults with narcolepsy. In addition, a presenter at SLEEP 2022 demonstrated that Xywav (calcium, magnesium, potassium and sodium oxybates, Jazz Pharmaceuticals) had a similar side effect profile to that seen in previous sodium oxybate trials when used to treat idiopathic hypersomnia.

“Some of the stimulants and wake-promoting agents, such as modafinil, armodafinil and solriamfetol, are also indicated for the treatment of sleepiness accompanying sleep apnea, which does not always respond well to CPAP therapy alone,” St. Louis said. “The approach in such patients is to first start with treating the disordered breathing optimally with CPAP, then adding a stimulant or wake-promoting medication if CPAP therapy alone is not effective in improving sleepiness symptoms.”

Collaboration

Collaboration between specialists and a multidisciplinary approach can also benefit patients with EDS.

A 2014 study in the Journal of Clinical Sleep Medicine also found that multidisciplinary sleep centers can improve the quality and cost-effectiveness of patient care. The researchers noted that “as a bona fide multidisciplinary specialty, sleep medicine provides opportunities to create and implement innovative means of improved patient care.”

St. Louis said psychiatrists and neurologists — as well as some pulmonologists, pediatricians and primary care physicians — can diagnose and manage sleep conditions that include EDS if they have sleep disorder training and are certified in sleep medicine.

“The capability and expertise in sleep medicine, which is a distinct specialty in medicine requiring subspecialty training, expertise and certification, is the key,” he said. “Generally, sleep neurologists have most dedicated interest and expertise in managing the central disorders of hypersomnolence, including narcolepsy and idiopathic hypersomnia, but many of the other sleep providers also have similar interest and expertise.”

Challenges

It cannot be overstated how important it is to get sufficient, good-quality sleep. A report published in Sleep Epidemiology in 2022 found that symptoms of insomnia and sleep apnea were linked to a 56% increased risk for all-cause mortality.

Despite current treatments and care recommendations, there are still critical unmet needs in the management of EDS. Modifying treatment to properly manage patient symptoms throughout the day, which involves timing of dosing and administration and adequate dosing, remains a challenge, according to St. Louis.

“Sometimes finding an effective medication option is a challenge as there is no good evidence to guide the initial or subsequent choice of medications,” he told Healio. “Much of this is individualized to patient characteristics and insurance coverage.”

Another barrier to accessing novel treatments is cost, as many newer medications are expensive and generally not well-covered by insurance, according to St. Louis.

“Access to expensive medications, and increasingly barriers put in place by insurers —preauthorization, denials and bureaucratic barriers to disincentivize patients and providers from choosing and using certain medications — is probably the largest challenge currently, impacting our patients to have timely access to medications they need,” he said.

“Legislative advocacy by both patients and providers is definitely an evolving need to force insurers to be responsible and accountable to deliver care to their insured patients.”

References:

• Bogan R, et al. Long-term safety during a clinical trial of lower-sodium oxybate in participants with narcolepsy with cataplexy. Presented at: SLEEP; June 4-8, 2022; Charlotte, N.C.
• Brown J, et al. BMJ. 2020;doi:10.1136/bmj.m1047.
• Dauvilliers Y, et al. Am J Respir Crit Care Med. 2020;doi:10.1164/rccm.201907-1284OC.
• Schweitzer PK, et al. Am J Respir Crit Care Med. 2019;doi:10.1164/rccm.201806-1100OC.
• Shelgikar AV, et al. J Clin Sleep Med. 2014;doi:10.5664/jcsm.3808.
• Sleep Apnea. https://www.sleepfoundation.org/sleep-apnea. Accessed on March 3, 2023.
• Sweetman A, et al. Sleep Epidemiol. 2022;doi:10.1016/j.sleepe.2022.100043.