sodium oxybate / Generic mfg. 
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  • ||||||||||  sodium oxybate / Generic mfg.
    Journal:  Effects of sodium oxybate on hypocretin/orexin and locus coeruleus neurons. (Pubmed Central) -  May 8, 2023   
    Therefore despite some similar effects on narcoleptic symptomatology, SXB does not produce anatomical changes similar to those elicited by opiates. Analysis of changes in other links in the cataplexy pathway might further illuminate SXB's mechanism of action on narcolepsy.
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    Trial completion:  An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy (clinicaltrials.gov) -  Dec 2, 2022   
    P4,  N=62, Completed, 
    Efficacy of oxybate treatment was maintained or improved, and most participants preferred LXB over SXB. Active, not recruiting --> Completed
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    Enrollment closed, Enrollment change:  An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy (clinicaltrials.gov) -  Sep 13, 2022   
    P4,  N=62, Active, not recruiting, 
    Recruiting --> Completed | N=45 --> 27 Recruiting --> Active, not recruiting | N=100 --> 62
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    Journal:  Calcium, Magnesium, Potassium and Sodium Oxybates (Xywav) in Sleep Disorders: A Profile of Its Use. (Pubmed Central) -  May 18, 2022   
    Furthermore, worsening in patient- and clinical-rated global scales, as well as measures of health-related quality of life were also seen with placebo versus lower-sodium oxybate. Lower-sodium oxybate is generally well tolerated, with the tolerability profile being largely consistent to that seen with sodium oxybate.
  • ||||||||||  sodium oxybate / Generic mfg.
    Clinical, Review, Journal:  Cognitive impairment following clinical or recreational use of gamma-hydroxybutyric acid (GHB). A systematic review. (Pubmed Central) -  Apr 13, 2022   
    Lower-sodium oxybate is generally well tolerated, with the tolerability profile being largely consistent to that seen with sodium oxybate. These results emphasize the need for awareness among clinicians and recreational users to minimize negative health consequences of recreational GHB use, particularly when high doses are used and GHB-induced comas occur.
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    Long-Term Effects of Lower-Sodium Oxybate on Functioning and Work Productivity in Participants With Idiopathic Hypersomnia ([VIRTUAL]) -  Mar 29, 2022 - Abstract #AAN2022AAN_4058;    
    LXB is a new oxybate treatment with 92% less sodium than sodium oxybate (Xyrem®)...ObjectivetttttttttTo report the long-term effects of lower-sodium oxybate (LXB; Xywav®) on functioning and work productivity in a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia (IH)...ConclusionstttttttttSustained efficacy on functioning (FOSQ-10) and work productivity (WPAI:SHP) in adults with IH was maintained throughout the open-label extension period. The overall safety profile was consistent with that of LXB in narcolepsy.
  • ||||||||||  sodium oxybate / Generic mfg.
    Journal:  Does sodium oxybate inhibit brain dopamine release in humans? An exploratory neuroimaging study. (Pubmed Central) -  Mar 16, 2022   
    We did not find evidence in this sample of human subjects of a robust striatal dopamine change, as was reported in non-human primates. Our preliminary data, requiring extension, suggest that a 3g sedative SO dose might cause slight transient inhibition of dopamine release in limbic striatum.
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    Trial completion, Real-world evidence, Real-world:  A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy (clinicaltrials.gov) -  Mar 10, 2022   
    P=N/A,  N=110, Completed, 
    Our preliminary data, requiring extension, suggest that a 3g sedative SO dose might cause slight transient inhibition of dopamine release in limbic striatum. Active, not recruiting --> Completed
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    New narcolepsy-ataxia and neuropathy phenotype not associated with DNMT1 (Concourse / Mezzanine) -  Feb 26, 2022 - Abstract #WSS2022WSS_1065;    
    A late onset case of narcolepsy, ataxia and peripheral neuropathy -not sensitive- and without deafness not linked to any genetic described mutation is shown. Due to the clinical similarities with the pictures associated with DNMT1 mutations, the case indicates that some phenotype of the so-called DNMT1- complex disorder might not always be related with the targeting sequence domain of DNMT1.
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    Journal:  Xywav - a mixed-salt oxybate oral solution for idiopathic hypersomnia. (Pubmed Central) -  Feb 8, 2022   
    Due to the clinical similarities with the pictures associated with DNMT1 mutations, the case indicates that some phenotype of the so-called DNMT1- complex disorder might not always be related with the targeting sequence domain of DNMT1. No abstract available
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    Enrollment closed, Enrollment change, Real-world evidence, Real-world:  A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy (clinicaltrials.gov) -  Oct 7, 2021   
    P=N/A,  N=111, Active, not recruiting, 
    In study participants with IH, LXB demon strated improvement in measures of functioning and work productivity. Recruiting --> Active, not recruiting | N=350 --> 111
  • ||||||||||  sodium oxybate / Generic mfg.
    KEY-10 - Brave New World: Guidelines and Treatment Strategies for Sickle Cell Disease (Castellana 1 / L3) -  Sep 15, 2021 - Abstract #PAINWeek2021PAINWeek_223;    
    This course evaluates those recommendations for acute pain management of VOC and uses a case based approach to discuss a sensible and balanced strategy for pain and symptom management. Learning Objectives: Summarize the healthcare disparities in accessing care for patients with sickle cell disease (SCD) Describe strategies to effectively manage acute and chronic pain in patients with SCD Review the recently published guidelines for SCD treatment and management Discuss the newly FDA-approved and emerging treatments for adult and pediatric patients with SCD Recognize effective communication techniques when diagnosing, treating, and managing patients with SCD
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    Enrollment open:  An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy (clinicaltrials.gov) -  Mar 24, 2021   
    P4,  N=100, Recruiting, 
    The supra–dose proportionality of LXB observed in participants with IH is consistent with results from other studies of LXB and SXB. Not yet recruiting --> Recruiting
  • ||||||||||  Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
    [VIRTUAL] Quality of Life in a Phase 3, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study of Lower-Sodium Oxybate in Adults With Narcolepsy With Cataplexy () -  Mar 18, 2021 - Abstract #AAN2021AAN_2518;    
    Objective: Establish the efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate, LXB; XywavTM; previously designated as JZP-258) in a double-blind randomized withdrawal study in adults with narcolepsy with cataplexy...Sodium oxybate (Xyrem®) is a standard of care for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy... HRQoL worsened in those randomized to placebo during the 2-week double-blind randomized withdrawal period but remained stable in participants who continued LXB treatment.
  • ||||||||||  Wakix (pitolisant) / Ferrer International, Paragon Biosci
    Journal:  Pitolisant (Wakix) for narcolepsy. (Pubmed Central) -  Mar 10, 2021   
    Participants not previously taking SXB achieved an individually optimized dose of LXB after a median of 3 adjustments. No abstract available
  • ||||||||||  sodium oxybate / Generic mfg.
    Enrollment change, Trial completion date, Trial withdrawal:  Evaluation of the Efficacy of Sodium Oxybate (Xyrem (clinicaltrials.gov) -  Mar 4, 2021   
    P1,  N=0, Withdrawn, 
    No abstract available N=20 --> 0 | Trial completion date: Dec 2020 --> Sep 2020 | Recruiting --> Withdrawn