Top 10 i doser doses9/6/2023 § Two patients experienced more than 1 AE. ‡ Both patients were recorded as having intentional overdose to improve sleep and were declared to be mild in severity and nonserious. † TEAEs considered by the investigator to be related to study drug or TEAEs with missing causality. ⁎ On-treatment dose, ie, dose taken at the time of AE. 1,2ĪE=adverse event COVID-19=coronavirus disease 2019 ECG=electrocardiogram SAE=serious adverse event TEAE=treatment-emergent adverse event Zol=zolpidem tartrate. Safety profile for subjects transitioning from Zol to DAYVIGO was consistent with the known safety profile of DAYVIGO based on the Clinical Development Program. 1 patient discontinued due to a serious AE related to the symptoms of COVID-19.All 7 patients recovered after discontinuing treatment 7 patients discontinued due to AEs §: Diarrhea, nausea, intentional overdose (not suicidal), ‡ sedation, cataplexy, hemiplegia, paralysis, sleep paralysis, abnormal dreams, anxiety.No deaths or treatment-emergent SAEs were reported.
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