Jazz Pharmaceuticals sleep disorder drug approved by European Commission

The European Commission has approved Sunosi, a Jazz Pharmaceuticals sleep disorder treatment. Sunosi was approved, in 75- and 150-milligram doses, to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea who did not respond to primary sleep apnea therapies such as continuous positive airway pressure. Jazz Pharmaceuticals, which is based in Dublin, Ireland, has major operations in Philadelphia where the company has nearly 200 employees.…
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news

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Introduction: Solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor, was effective in treating excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea (OSA) in phase 3 studies.Aims and Objectives: To evaluate long-term safety and efficacy of solriamfetol for EDS in narcolepsy and OSA.Methods: Participants who completed prior solriamfetol studies initiated open-label (OL) solriamfetol with a 2-wk titration followed by a maintenance phase of ≤50 wk. A 2-wk placebo-controlled randomized withdrawal (RW) phase began after 6 mo. Change in Epworth Sleepiness Scale (ESS) during ...
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Sleep and control of breathing Source Type: research
The dual-acting dopamine and norepinephrine reuptake inhibitor showed durable effects in reducing excessive sleepiness in patients with narcolepsy or obstructive sleep apnea (OSA).International Approvals
Source: Medscape Neurology and Neurosurgery Headlines - Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news
Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea If approved by the European Commission for... Biopharmaceuticals, Regulatory Jazz Pharmaceuticals, solriamfetol, narcolepsy
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news
Sachin Sureshbabu, Ajay Asranna, Sudhir Peter, Sobhana Chindripu, Gaurav K MittalAnnals of Indian Academy of Neurology 2019 22(4):537-538
Source: Annals of Indian Academy of Neurology - Category: Neurology Authors: Source Type: research
Excessive daytime sleepiness (EDS) is one of the leading reasons that patients present to sleep clinics. Approximately 10% to 14% of the adults report that excessive sleepiness interferes with their daily lives. Common causes of EDS include obstructive sleep apnea, sleep deprivation, circadian rhythm disorders, medication effects, psychiatric conditions especially depression, and primary hypersomnia such as narcolepsy or central idiopathic hypersomnia. Vitamin B12 deficiency is a rare cause of EDS. We are presenting a case of severe vitamin B12 deficiency as an unusual and rare cause of hypersomnia.Citation:Khawaja I, Ying...
Source: Journal of Clinical Sleep Medicine : JCSM - Category: Sleep Medicine Source Type: research
Drowsy driving is common and causes 21% of fatal crashes. Individuals at risk include young men, shift workers, older adults, and people with chronic short sleep duration, untreated obstructive sleep apnea (OSA), and narcolepsy. Untreated OSA is a particular concern in commercial drivers, who are at higher risk for the disorder. Treatment for sleep problems such as sleep extension for chronic short sleep, positive airway pressure (PAP) for OSA, pharmacologic treatments, and drowsy driving countermeasures may reduce the risk of crashes. Implementing screening measures to identify common sleep problems contributing to drowsy...
Source: Sleep Medicine Clinics - Category: Sleep Medicine Authors: Source Type: research
Date: August 26, 2019 Issue #:  1579Summary:  The FDA has approved solriamfetol (Sunosi– Jazz), a dopamine and norepinephrine reuptake inhibitor (DNRI), to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). Pitolisant(Wakix), an H3-receptor antagonist/inverse agonist recently approved by the FDA for treatment of excessive daytime sleepiness in patients with narcolepsy, will be reviewed in a future issue.
Source: The Medical Letter - Category: Drugs & Pharmacology Authors: Source Type: research
Authors: Kaufman MB Abstract Sunosi (solriamfetol) tablets for excessive daytime sleepiness with narcolepsy or obstructive sleep apnea; Zulresso (brexanolone) injection for postpartum depression in adults; Mayzent (siponimod) tablets for adults with relapsing forms of MS. PMID: 31160867 [PubMed]
Source: P and T - Category: Drugs & Pharmacology Tags: P T Source Type: research
This study aimed to examine the prevalence of REM-related OSA in narcolepsy patients. Methods From January 2013 to April 2018, 141 adult patients were diagnosed with narcolepsy using nocturnal polysomnography and the multiple sleep latency test. The prevalence of REM-related OSA in narcolepsy patients was retrospectively reviewed. Three criteria were used to determine REM-related OSA: Definition #1, an overall apnea-hypopnea index (AHI) ≥5 and AHI during REM (AHIREM)/AHI during non-rapid eye movement (NREM) (AHINREM) ≥2; Definition #2, an overall AHI ≥5 and AHIREM/AHINREM≥2 and AHINREM
Source: Internal Medicine - Category: Internal Medicine Tags: Intern Med Source Type: research
The dual-acting dopamine and norepinephrine reuptake inhibitor showed durable effects in reducing excessive sleepiness in patients with narcolepsy or obstructive sleep apnea.FDA Approvals
Source: Medscape Neurology and Neurosurgery Headlines - Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news
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