Abstract | STUDY OBJECTIVES: METHODS: Participants with OSA who completed prior solriamfetol studies received solriamfetol 75, 150, or 300 mg/day for ≤ 52 weeks. The main efficacy outcome was the Epworth Sleepiness Scale score. Primary therapy use was summarized as the percentage of nights, the number of hours/night, and the percentage of nights with use ≥ 50%/night (%). Efficacy and primary therapy use are reported for participants who directly enrolled from a previous 12-week study and had ≤ 40 weeks of open-label treatment (n = 333). Safety data are reported for all participants (n = 417). RESULTS: Mean ESS scores in adherent (n = 255) and nonadherent (n = 78) subgroups, respectively, were 15.0 and 15.8 at baseline (of 12-week study) and 6.5 and 6.8 at week 40. For participants using an airway therapy, mean use at baseline was 90% of nights, 6.6 hours/night, and use ≥ 50%/night on 90% of nights; changes from baseline to week 40 were minimal (0.9%, -0.8 hours, and 6.5%, respectively). Common adverse events (both subgroups) included headache, nasopharyngitis, insomnia, dry mouth, nausea, anxiety, and upper respiratory tract infection. CONCLUSIONS: CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or OSA; URL: https://clinicaltrials.gov/ct2/show/NCT02348632; Identifier: NCT02348632 and Registry: EU Clinical Trials Register; Identifier: 2014-005489-31; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-005489-31..
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Authors | Paula K Schweitzer, Kingman P Strohl, Geert Mayer, Russell Rosenberg, Patricia Chandler, Michelle Baladi, Lawrence Lee, Atul Malhotra |
Journal | Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine
(J Clin Sleep Med)
Vol. 17
Issue 4
Pg. 659-668
(04 01 2021)
ISSN: 1550-9397 [Electronic] United States |
PMID | 33179591
(Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 2021 American Academy of Sleep Medicine. |
Chemical References |
- Carbamates
- Phenylalanine
- solriamfetol
|
Topics |
- Carbamates
- Continuous Positive Airway Pressure
- Disorders of Excessive Somnolence
- Humans
- Phenylalanine
(analogs & derivatives)
- Sleep Apnea, Obstructive
- Treatment Outcome
|