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      Profile of Solriamfetol in the Management of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea: Focus on Patient Selection and Perspectives

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          Abstract

          Excessive sleepiness (ES) is a symptom of obstructive sleep apnea (OSA) and narcolepsy that has severe consequences. Wake-promoting drugs and stimulants are utilized as accessory treatment in OSA to reduce propensity to sleep but they do not improve sleep-disordered breathing. Solriamfetol is a first-line therapeutic agent to combat sleepiness in OSA and narcolepsy patients that is approved both by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). For excessively sleepy adult patients with OSA despite primary treatment or narcolepsy patients without cataplexy, solriamfetol may be used as initial therapy or as replacement therapy in patients who fail treatment or experience unacceptable side effects with modafinil, armodafinil, pitolisant, or stimulants. It can also be used as add-on therapy in OSA or narcolepsy patients when ES is only partially controlled with modafinil, armodafinil, pitolisant, sodium oxybate, or stimulants. Solriamfetol is a phenylalanine derivative whose wake-promoting action may be mediated through its selective dopamine and norepinephrine reuptake inhibition. This paper reviews the profile of solriamfetol in treating ES associated with OSA or narcolepsy and discusses patient selection and clinical perspectives. Mechanism of action, pharmacology, pharmacokinetics, clinical efficacy, and tolerability of solriamfetol are described. The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) solriamfetol trials demonstrated the efficacy of solriamfetol in reducing propensity to sleep and maintaining wakefulness, with significant improvements in mean maintenance of wakefulness test (MWT) sleep latencies and significant reduction in Epworth Sleepiness Scale (ESS) scores compared to placebo. With solriamfetol, significantly higher percentages of patients showed improvement in patient’s and clinician’s global impression of change.

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          Most cited references54

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          Increased prevalence of sleep-disordered breathing in adults.

          Sleep-disordered breathing is a common disorder with a range of harmful sequelae. Obesity is a strong causal factor for sleep-disordered breathing, and because of the ongoing obesity epidemic, previous estimates of sleep-disordered breathing prevalence require updating. We estimated the prevalence of sleep-disordered breathing in the United States for the periods of 1988-1994 and 2007-2010 using data from the Wisconsin Sleep Cohort Study, an ongoing community-based study that was established in 1988 with participants randomly selected from an employed population of Wisconsin adults. A total of 1,520 participants who were 30-70 years of age had baseline polysomnography studies to assess the presence of sleep-disordered breathing. Participants were invited for repeat studies at 4-year intervals. The prevalence of sleep-disordered breathing was modeled as a function of age, sex, and body mass index, and estimates were extrapolated to US body mass index distributions estimated using data from the National Health and Nutrition Examination Survey. The current prevalence estimates of moderate to severe sleep-disordered breathing (apnea-hypopnea index, measured as events/hour, ≥15) are 10% (95% confidence interval (CI): 7, 12) among 30-49-year-old men; 17% (95% CI: 15, 21) among 50-70-year-old men; 3% (95% CI: 2, 4) among 30-49-year-old women; and 9% (95% CI: 7, 11) among 50-70 year-old women. These estimated prevalence rates represent substantial increases over the last 2 decades (relative increases of between 14% and 55% depending on the subgroup).
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            Prevalence of obstructive sleep apnea in the general population: A systematic review.

            With this systematic review we aimed to determine the prevalence of obstructive sleep apnea (OSA) in adults in the general population and how it varied between population sub-groups. Twenty-four studies out of 3807 found by systematically searching PubMed and Embase databases were included in this review. Substantial methodological heterogeneity in population prevalence studies has caused a wide variation in the reported prevalence, which, in general, is high. At ≥5 events/h apnea-hypopnea index (AHI), the overall population prevalence ranged from 9% to 38% and was higher in men. It increased with increasing age and, in some elderly groups, was as high as 90% in men and 78% in women. At ≥15 events/h AHI, the prevalence in the general adult population ranged from 6% to 17%, being as high as 49% in the advanced ages. OSA prevalence was also greater in obese men and women. This systematic review of the overall body of evidence confirms that advancing age, male sex, and higher body-mass index increase OSA prevalence. The need to a) consider OSA as having a continuum in the general population and b) generate consensus on methodology and diagnostic threshold to define OSA so that the prevalence of OSA can be validly compared across regions and countries, and within age-/sex-specific subgroups, is highlighted.
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              International Classification of Sleep Disorders

              "The International Classification of Sleep Disorders - Third Edition (ICSD-3) is the authoritative clinical text for the diagnosis of sleep disorders. This is an essential reference for all clinicians with sleep disorders patients. Updated in 2014, the third revision to the ICSD features significant content changes, including new nomenclature, classifications and diagnoses. The book also features accurate diagnostic codes for the corresponding ICD-9 and ICD-10 diagnoses at the beginning of each diagnosis section of the ICSD-3. Disorders are grouped into six major categories: Insomnia ; Sleep Related Breathing Disorders ; Central Disorders of Hypersomnolence ; Circadian Rhythm Sleep-Wake Disorders ; Parasomnias ; Sleep Related Movement Disorders." --
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                Author and article information

                Journal
                Nat Sci Sleep
                Nat Sci Sleep
                nss
                nss
                Nature and Science of Sleep
                Dove
                1179-1608
                25 January 2021
                2021
                : 13
                : 75-91
                Affiliations
                [1 ]Department of Psychiatry & Behavioral Sciences, Division of Sleep Medicine, Stanford University , Redwood City, CA 94063, USA
                Author notes
                Correspondence: Vivien C Abad Department of Psychiatry & Behavioral Sciences Division of Sleep Medicine, Stanford University Outpatient Center , 450 Broadway St. Pavilion C.2nd Floor MC5704, Redwood City, CA94063, USATel +1 650 723 6601Fax +1 650 721 3448 Email vivien.abad@stanford.edu
                Author information
                http://orcid.org/0000-0001-9384-7574
                Article
                245020
                10.2147/NSS.S245020
                7846869
                33531850
                17f419d7-d384-4c88-a657-a9fd1c41e85b
                © 2021 Abad.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 06 November 2020
                : 07 January 2021
                Page count
                Figures: 0, Tables: 3, References: 74, Pages: 17
                Funding
                Funded by: no funding to report;
                There is no funding to report.
                Categories
                Review

                excessive daytime sleepiness,obstructive sleep apnea,narcolepsy,solriamfetol,drug profile,clinical perspective

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