Director of Research, St. Luke's Sleep Medicine and Research Center

Paula K. Schweitzer, PhD

"Patients and clinicians sometimes don’t differentiate between feeling fatigued and having no energy versus actual sleepiness where they can’t stay awake. That may be an important distinction in determining both cause of the complaint, as well as how to treat the complaint.”

An open-label extension trial (NCT02348632) led by Paula K. Schweitzer, PhD, recently found that solriamfetol (Sunosi; Jazz Pharmaceuticals), a drug FDA-approved for the treatment of excessive daytime sleepiness (EDS), is safe and efficacious in patients with obstructive sleep apnea (OSA), regardless of adherence to primary OSA therapy. Currently, the only other drugs approved for the treatment of EDS in patients with OSA are modafinil (Provigil; Teva) and armodafinil (Nuvigil; Teva), with a number of investigational agents and modalities still in the pipeline.

Solriamfetol, a dual-acting dopamine and norepinephrine reuptake inhibitor, has yet to be observed in comparator studies with other approved or non-approved treatment options, which, according to Schweitzer, can make tailoring treatment regimens even more difficult. Schweitzer, director of research, St. Luke’s Sleep Medicine and Research Center, claims that the overall knowledge of EDS and OSA needs improvement in order to expand the treatment toolbox and provide personalized and individualized care for patients.

Schweitzer discussed Solriamfetol’s advantages as an EDS treatment, the EDS treatment landscape, and which future research endeavors peak her interest going forward.

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The director of research at St. Luke’s Sleep Medicine and Research Center discussed the current treatment landscape for excessive daytime sleepiness and how solriamfetol plays a role.

Expanding Knowledge, Treatment Options on Excessive Daytime Sleepiness: Paula K. Schweitzer, PhD

"Sometimes patients with depression feel sleepy during the daytime. If the depression is inadequately treated, you may want to treat that. But sometimes it persists despite everything and sometimes the patient can’t always optimize treatment for all these conditions for whatever reason.”

An analysis conducted by Paula K. Schweitzer, PhD, and her colleagues evaluated the efficacy of solriamfetol (Sunosi; Jazz Pharmaceuticals), an FDA-approved treatment for excessive daytime sleepiness (EDS), in subgroups of participant with obstructive sleep apnea (OSA) who were adherent or nonadherent to primary OSA therapy. The investigators noted that therapy with continuous positive airway pressure (CPAP) and oral appliances has improved EDS in some patients, particularly those who are adherent to therapy, but that even patients who use their OSA therapy in an adherent manner (>6 hours/night), residual EDS may occur.

Previous reports have shown 9% to 22% of CPAP-treated patients have residual EDS, but that the underlying mechanisms are unclear. Schweitzer, director of researcher at St Luke’s Sleep Medicine and Research Center, claims that there are a number of reasons a patient can be experiencing sleepiness, including inadequate treatment and other controlled factors like insufficient sleep.

sat down with Schweitzer to get her thoughts on what is currently known about residual EDS as well as what clinicians should continue to key in on in the future. She also stresses the importance of continuing to research these aspects, especially by getting a closer look at the brain.

Schweitzer PK, Strohl KP, Mayer G, et al. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. 

Published online February 1, 2021. doi: 10.5664/jcsm.8992

The director of research at St. Luke’s Sleep Medicine and Research Center detailed the reasons for residual excessive daytime sleepiness and the lack of literature on the topic. 

Residual Excessive Daytime Sleepiness in CPAP-Treated Patients: Paula K. Schweitzer, PhD

"We decided to use both patients that were adherent to treatment, as well as patients that were nonadherent to treatment because both types exist. There’s a clinical need for treatment in both situations.”

A recently published open-label extension trial (NCT02348632) showed that the magnitude of the 

 (Sunosi; Jazz Pharmaceuticals) treatment for up to 1 year is similar regardless of adherence to primary obstructive sleep apnea (OSA) therapy. Led by Paula K. Schweitzer, PhD, the study also found that the level of primary OSA therapy use remained unchanged over the duration of solriamfetol treatment, demonstrating that long-term treatment of excessive daytime sleepiness (EDS) with solriamfetol does not affect the patients’ use of primary OSA therapy.

Schweitzer and colleagues used the Epworth Sleepiness Scale (ESS) as the main efficacy outcome in patients with OSA who completed prior solriamfetol studies. Patients in the open-label extension received solriamfetol 75, 150, or 300 mg/day for less than or equal to 52 weeks.

Schweitzer, director of research at St. Luke’s Sleep Medicine and Research Center, claims that nonadherence is common, with a relatively large population of those who don’t enjoy continuous positive airway pressure or have trouble sleeping with it. In an interview with 

, Schweitzer discussed the motivation behind her study, and whether previous concerns played a role into her decision to conduct this research.

The director of research at St. Luke’s Sleep Medicine and Research Center discussed the motivation behind her study assessing solriamfetol in patient’s adherent and nonadherent to primary OSA therapy. 

Paula K. Schweitzer, PhD

Articles

Expanding Knowledge, Treatment Options on Excessive Daytime Sleepiness: Paula K. Schweitzer, PhD

Residual Excessive Daytime Sleepiness in CPAP-Treated Patients: Paula K. Schweitzer, PhD

Evaluating Solriamfetol in Patients Adherent to OSA Therapy: Paula K. Schweitzer, PhD

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