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1. Solriamfetol (Sunosi) - To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea

Solriamfetol (Sunosi) - To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea Drug Approval Package: Sunosi U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: Sunosi Company: Jazz Pharmaceuticals Ireland Limited Application Number: 211230 Approval Date: 03/20/2019 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF

2019 FDA - Drug Approval Package

3. Narcolepsy

Narcolepsy Narcolepsy - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Narcolepsy Last reviewed: February 2019 Last updated: January 2018 Summary Narcolepsy is a chronic condition characterised by a disruption of the sleep-wake cycle and rapid eye movement (REM) sleep intrusion. The classic tetrad of narcolepsy, seen in only 10% to 15% of cases, includes excessive daytime sleepiness, cataplexy, sleep paralysis (...) , and hypnagogic/hypnopompic hallucinations. The only clinical manifestation that is specific to narcolepsy is cataplexy. Disease onset is usually in the second decade of life. Multiple sleep latency test usually shows shortened sleep latency and at least 2 sleep-onset REM periods. Therapy involves lifestyle modification, stimulants for daytime sleepiness, and drug treatment for cataplexy. Definition Narcolepsy is a chronic sleep boundary disorder that affects the control of sleep and wakefulness with rapid

2018 BMJ Best Practice

4. Exploring the clinical features of narcolepsy type 1 versus narcolepsy type 2 from European Narcolepsy Network database with machine learning (PubMed)

Exploring the clinical features of narcolepsy type 1 versus narcolepsy type 2 from European Narcolepsy Network database with machine learning Narcolepsy is a rare life-long disease that exists in two forms, narcolepsy type-1 (NT1) or type-2 (NT2), but only NT1 is accepted as clearly defined entity. Both types of narcolepsies belong to the group of central hypersomnias (CH), a spectrum of poorly defined diseases with excessive daytime sleepiness as a core feature. Due to the considerable overlap (...) of symptoms and the rarity of the diseases, it is difficult to identify distinct phenotypes of CH. Machine learning (ML) can help to identify phenotypes as it learns to recognize clinical features invisible for humans. Here we apply ML to data from the huge European Narcolepsy Network (EU-NN) that contains hundreds of mixed features of narcolepsy making it difficult to analyze with classical statistics. Stochastic gradient boosting, a supervised learning model with built-in feature selection, results

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2018 Scientific reports

5. [Pitolisant (narcolepsy) - assessment according to õ 35a (para. 1, sentence 10) Social Code Book V]

[Pitolisant (narcolepsy) - assessment according to õ 35a (para. 1, sentence 10) Social Code Book V] Pitolisant (narkolepsie): bewertung gemäß § 35a abs. 1 satz 10 SGB V; dossierbewertung; auftrag G16-12 [Pitolisant (narcolepsy) – assessment according to § 35a (para. 1, sentence 10) Social Code Book V] Pitolisant (narkolepsie): bewertung gemäß § 35a abs. 1 satz 10 SGB V; dossierbewertung; auftrag G16-12 [Pitolisant (narcolepsy) – assessment according to § 35a (para. 1, sentence 10) Social Code (...) Book V] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Pitolisant (narkolepsie): bewertung gemäß § 35a abs. 1 satz 10 SGB V; dossierbewertung; auftrag G16-12. [Pitolisant (narcolepsy) – assessment

2017 Health Technology Assessment (HTA) Database.

6. The MSLT is Repeatable in Narcolepsy Type 1 But Not Narcolepsy Type 2: A Retrospective Patient Study (PubMed)

The MSLT is Repeatable in Narcolepsy Type 1 But Not Narcolepsy Type 2: A Retrospective Patient Study To examine repeatability of Multiple Sleep Latency Test (MSLT) results in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) according to the criteria of the International Classification of Sleep Disorders, Third Edition (ICSD-3).Repeatability of the MSLT was retrospectively evaluated in NT1 (n = 60) and NT2 (n = 54) cases, and controls (n = 15). All subjects had documented HLA-DQB1*06:02 (...) status and/or hypocretin-1 levels from cerebrospinal fluid. All subjects had undergone 2 MSLTs (≥ 1 meeting ICSD-3 criteria for narcolepsy). Repeatability was explored in children versus adults and in those on versus not on medication(s). Subsample and multivariate analysis were performed.Both MSLTs in unmedicated patients were positive for narcolepsy in 78%, 18%, and 7% of NT1, NT2, and controls, respectively. NT2 cases changed to idiopathic hypersomnia or to a negative MSLT 26% and 57% of the time

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2018 Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine

7. Narcolepsy, Anesthesia, and Sedation: A Survey of the Perioperative Experience of Patients With Narcolepsy. (PubMed)

Narcolepsy, Anesthesia, and Sedation: A Survey of the Perioperative Experience of Patients With Narcolepsy. Patients with narcolepsy may be at increased perioperative risk due to the interactions among anesthesia, narcolepsy, and narcolepsy medications. This study sought to determine the perioperative experience of narcoleptic patients undergoing anesthesia or sedation, the frequency of perioperative counseling, and self-reported surgical complications.A 22-question survey was developed (...) by expert consensus and distributed by the Narcolepsy Network. Recruitment was via the Narcolepsy Network's list-serve and a Facebook link to the survey. One thousand and twenty respondents reported a diagnosis of narcolepsy and 1 or more procedures under anesthesia or sedation. Descriptive, comparative statistics and logistic regression were utilized.Respondents were mostly women (79.5%) and Caucasian (84.9%), with a mean age of 45 ± 16 years. Most respondents did not receive counseling regarding

2018 Anesthesia and Analgesia

8. A randomized study of solriamfetol for excessive sleepiness in narcolepsy

A randomized study of solriamfetol for excessive sleepiness in narcolepsy Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor with wake-promoting effects. This phase 3 study (NCT02348593) evaluated the safety and efficacy of solriamfetol in narcolepsy.Patients with narcolepsy with mean sleep latency <25 minutes on the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS) score ≥10, and usual nightly sleep ≥6 hours were randomized to solriamfetol (...) (10.7%), nasopharyngitis (9.0%), dry mouth (7.3%), and anxiety (5.1%).Solriamfetol has the potential to be an important therapeutic option for the treatment of impaired wakefulness and excessive sleepiness in patients with narcolepsy. ANN NEUROL 2019;85:359-370.© 2019 The Authors. Annals of Neurology published by Wiley Periodicals, Inc. on behalf of American Neurological Association.

2019 EvidenceUpdates

10. Correction: Absence of anti-hypocretin receptor 2 autoantibodies in post pandemrix narcolepsy cases. (PubMed)

Correction: Absence of anti-hypocretin receptor 2 autoantibodies in post pandemrix narcolepsy cases. [This corrects the article DOI: 10.1371/journal.pone.0187305.].

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2019 PLoS ONE

11. Narcolepsy with or without cataplexy in adults: pitolisant

Narcolepsy with or without cataplexy in adults: pitolisant Narcolepsy with or without cataple Narcolepsy with or without cataplexy in adults: xy in adults: pitolisant pitolisant Evidence summary Published: 14 March 2017 nice.org.uk/guidance/es8 pathways K Ke ey points y points The content of this evidence summary was up-to-date in March 2017. See summaries of product characteristics (SPC), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. Regulatory (...) status: Regulatory status: New medicine. Pitolisant is a histamine H3-receptor antagonist/inverse agonist that is licensed for the treatment of narcolepsy with or without cataplexy in adults. It was launched in the UK in September 2016. Ov Overview erview Narcolepsy is a rare, disabling long-term brain disorder that can result in excessive daytime sleepiness, sleep attacks, cataplexy, sleep paralysis, excessive dreaming and disturbed nocturnal sleep. This evidence summary reviewed 2 small randomised

2017 National Institute for Health and Clinical Excellence - Advice

12. Epidemiology of narcolepsy: a systematic review

Epidemiology of narcolepsy: a systematic review Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email salutation (e.g. "Dr Smith

2019 PROSPERO

13. High Rates of Psychiatric Comorbidity in Narcolepsy: Findings From the Burden of Narcolepsy Disease (BOND) Study of 9,312 Patients in the United States. (PubMed)

High Rates of Psychiatric Comorbidity in Narcolepsy: Findings From the Burden of Narcolepsy Disease (BOND) Study of 9,312 Patients in the United States. To evaluate psychiatric comorbidity patterns in patients with a narcolepsy diagnosis in the United States.Truven Health Analytics MarketScan Research Databases were accessed to identify individuals ≥ 18 years of age with ≥ 1 ICD-9 diagnosis code(s) for narcolepsy continuously insured between 2006 and 2010 and non-narcolepsy controls matched 5:1 (...) (age, gender, region, payer). Extensive subanalyses were conducted to confirm the validity of narcolepsy definitions. Narcolepsy subjects and controls were compared for frequency of psychiatric comorbid conditions (based on ICD-9 codes/Clinical Classification Software [CCS] level 2 categories) and psychiatric medication use.The final population included 9,312 narcolepsy subjects and 46,559 controls (each group, mean age = 46.1 years; 59% female). All categories of mental illness were significantly

2016 Journal of Clinical Psychiatry

14. A Randomized Study of Solriamfetol for Excessive Sleepiness in Narcolepsy. (PubMed)

A Randomized Study of Solriamfetol for Excessive Sleepiness in Narcolepsy. Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor with wake-promoting effects. This phase 3 study (NCT02348593) evaluated the safety and efficacy of solriamfetol in narcolepsy.Patients with narcolepsy with mean sleep latency <25 minutes on the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS) score ≥10, and usual nightly sleep ≥6 hours were randomized to solriamfetol (...) (10.7%), nasopharyngitis (9.0%), dry mouth (7.3%), and anxiety (5.1%).Solriamfetol has the potential to be an important therapeutic option for the treatment of impaired wakefulness and excessive sleepiness in patients with narcolepsy. ANN NEUROL 2019;85:359-370.© 2019 The Authors. Annals of Neurology published by Wiley Periodicals, Inc. on behalf of American Neurological Association.

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2019 Annals of Neurology

15. The neuronal network of laughing in young patients with untreated narcolepsy. (PubMed)

The neuronal network of laughing in young patients with untreated narcolepsy. To investigate the neuronal correlates of spontaneous laughter in drug-naive pediatric patients with narcolepsy type I (NT1) compared to healthy controls by means of blood oxygen level-dependent (BOLD) MRI.Twenty-one children/adolescents with recent onset of NT1 and 21 age- and sex-matched healthy controls were studied with fMRI while viewing funny videos using a naturalistic paradigm. Whole-brain hemodynamic

2019 Neurology

16. Shared T cell receptor chains in blood memory CD4<sup>+</sup> T cells of narcolepsy type 1 patients. (PubMed)

Shared T cell receptor chains in blood memory CD4+ T cells of narcolepsy type 1 patients. Convergent evidence points to the involvement of T cells in the pathogenesis of narcolepsy type 1 (NT1). Here, we hypothesized that expanded disease-specific T cell clones could be detected in the blood of NT1 patients. We compared the TCR repertoire of circulating antigen-experienced CD4+ and CD8+ T cells from 13 recently diagnosed NT1 patients and 11 age-, sex-, and HLA-DQB1*06:02-matched

2019 Journal of Autoimmunity

17. Using a Facebook Forum to Cope With Narcolepsy After Pandemrix Vaccination: Infodemiology Study. (PubMed)

Using a Facebook Forum to Cope With Narcolepsy After Pandemrix Vaccination: Infodemiology Study. In 2010, newly diagnosed narcolepsy cases among children and adolescents were seen in several European countries as a consequence of comprehensive national vaccination campaigns with Pandemrix against H1N1 influenza. Since then, a large number of people have had to live with narcolepsy and its consequences in daily life, such as effects on school life, social relationships, and activities. Initially (...) , the adverse effects were not well understood and there was uncertainty about whether there would be any financial compensation. The situation remained unresolved until 2016, and during these years affected people sought various ways to join forces to handle the many issues involved, including setting up a social media forum.Our aim was to examine how information was shared, and how opinions and beliefs about narcolepsy as a consequence of Pandemrix vaccination were formed through discussions on social

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2019 Journal of medical Internet research

18. Knowledge Gaps in the Perioperative Management of Adults With Narcolepsy: A Call for Further Research. (PubMed)

Knowledge Gaps in the Perioperative Management of Adults With Narcolepsy: A Call for Further Research. There is increasing awareness that sleep disorders may be associated with increased perioperative risk. The Society of Anesthesia and Sleep Medicine created the Narcolepsy Perioperative Task Force: (1) to investigate the current state of knowledge of the perioperative risk for patients with narcolepsy, (2) to determine the viability of developing perioperative guidelines for the management (...) of patients with narcolepsy, and (3) to delineate future research goals and clinically relevant outcomes. The Narcolepsy Perioperative Task Force established that there is evidence for increased perioperative risk in patients with narcolepsy; however, this evidence is sparse and based on case reviews, case series, and retrospective reviews. Mechanistically, there are a number of potential mechanisms by which patients with narcolepsy could be at increased risk for perioperative complications. These include

2019 Anesthesia and Analgesia

19. A functional autoantibody in narcolepsy. (PubMed)

A functional autoantibody in narcolepsy. Narcolepsy is widely believed to have an autoimmune basis, but conventional immunological approaches have failed to detect a serum autoantibody marker. Since cholinergic hyperactivity is a feature of narcolepsy-cataplexy, we transferred IgG from nine patients with narcolepsy and nine healthy controls to mice and assessed the effect on smooth muscle contractile responses to cholinergic stimulation. IgG from all narcolepsy patients significantly enhanced (...) bladder contractile responses to the muscarinic agonist carbachol and to neuronally released acetylcholine compared with control IgG (p<0.0001), whereas contraction of the sympathetically innervated vas deferens was unaltered. Our findings provide direct evidence for the autoimmune hypothesis of narcolepsy.

2017 Lancet

20. Increased creative thinking in narcolepsy. (PubMed)

Increased creative thinking in narcolepsy. Some studies suggest a link between creativity and rapid eye movement sleep. Narcolepsy is characterized by falling asleep directly into rapid eye movement sleep, states of dissociated wakefulness and rapid eye movement sleep (cataplexy, hypnagogic hallucinations, sleep paralysis, rapid eye movement sleep behaviour disorder and lucid dreaming) and a high dream recall frequency. Lucid dreaming (the awareness of dreaming while dreaming) has been (...) correlated with creativity. Given their life-long privileged access to rapid eye movement sleep and dreams, we hypothesized that subjects with narcolepsy may have developed high creative abilities. To test this assumption, 185 subjects with narcolepsy and 126 healthy controls were evaluated for their level of creativity with two questionnaires, the Test of Creative Profile and the Creativity Achievement Questionnaire. Creativity was also objectively tested in 30 controls and 30 subjects with narcolepsy

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2019 Brain

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