ArticleSleep medicine2017
Safety and efficacy of long-term use of sodium oxybate for narcolepsy with cataplexy in routine clinical practice.
Article in Sleep medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Long-term Efficacy and Safety of Sodium Oxybate in Treating Alcohol Use Disorder: A Systematic Review and Meta-Analysis.Current neuropharmacology · 2025Pooled it
- Narcolepsy and psychosis: A systematic review.Acta psychiatrica Scandinavica · 2021Pooled it
- Trial
- Long-term safety and maintenance of efficacy of sodium oxybate in the treatment of narcolepsy with cataplexy in pediatric patients.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022Trial
- Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2020Trial
- Narcolepsy and Idiopathic Hypersomnia Real-World Treatment Patterns and Changes in Alerting Agent Use After Low-Sodium Oxybate Initiation: A Retrospective Claims Analysis.Neurology and therapy · 2026Article
- A historical overview of the cardiovascular safety of sodium oxybate: clinical trials, clinical experience.Sleep advances : a journal of the Sleep Research Society · 2026Review
- Practical Guidance for Initiation and Management of Patients on Once-Nightly Sodium Oxybate for Narcolepsy Treatment: Modified Delphi Panel Consensus Recommendations.Neurology and therapy · 2026Article
- Recent Advances and Emerging Pharmacotherapeutic Approaches for Central Hypersomnolence Disorders.Clinical pharmacology : advances and applications · 2026Review
- Long-Term Daytime Use of Sodium Oxybate in Laryngeal Dystonia: A Follow-Up Online Survey Study.The Laryngoscope · 2026Article
- A Comprehensive Review of Current and Emerging Treatments for Narcolepsy Type 1.Journal of clinical medicine · 2025Review
- Sodium Oxybate as a Potential New Treatment for Catatonia in Patients With Depression, Bipolar Disorder, or a Psychotic Disorder: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2025Article
- Narcolepsy: Beyond the Classic Pentad.CNS drugs · 2025Review
- Review
- The role of the clinical pharmacist in the respiratory or sleep multidisciplinary team.Breathe (Sheffield, England) · 2023Review
- Long-term follow-up on the effects of sodium oxybate on daytime sleepiness and sleep architecture in patients with narcolepsy type 1.Revista de neurologia · 2023Observational
- Individualized Treatment Patterns for Patients with Narcolepsy Treated with Oxybate: A Clinical Practice Perspective.Nature and science of sleep · 2023Article
- Pharmacological Interventions for Excessive Daytime Sleepiness in Adults with Narcolepsy: A Systematic Review and Network Meta-Analysis.Journal of clinical medicine · 2022Article
- Clinical Characteristics of Cataplectic Attacks in Type 1 Narcolepsy.Current neurology and neuroscience reports · 2020Review
- Recently Approved and Upcoming Treatments for Narcolepsy.CNS drugs · 2020Review
Corrections and comments
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Authors and funding
12 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundSodium oxybate is licensed in Europe for the treatment of narcolepsy with cataplexy in adults. The aim of this study was to assess the efficacy and safety of sodium oxybate in clinical practice in patients with narcolepsy and cataplexy refractory to other treatments. MATERIALS AND
methodsThis was a retrospective single centre study including patients with severe narcolepsy with cataplexy refractory to other treatments, who were initiated on sodium oxybate between 2009 and 2015. Patients were allowed to be on other stimulants or/and anti-cataplectic agents. Epworth sleepiness scale (ESS) and weekly cataplexy events were recorded. Side effects (SEs) were recorded at every follow-up visit.
results90 patients were prescribed sodium oxybate, with a total of 3116 patient-months of drug exposure. ESS and weekly cataplexy events were significantly reduced by sodium oxybate for all patients (ΔESS = 4.3 ± 4.4 and Δcataplexy = 21.8 ± 18.5 events/week; p < 0.0001, respectively). The required maintenance dose could not be predicted based upon gender, body mass index, or clinical factors. 60% of patients were able to reduce or come off other medications. Half of the patients experienced at least one SE, and 26.6% had to stop treatment due to limiting SEs. Nausea, mood swings and enuresis were the most commonly reported SEs. SEs that led to drug discontinuation, particularly psychosis, were associated with increasing age and were observed early after the initiation of the drug.
conclusionsSodium oxybate provides a good clinical efficacy and acceptable safety profile in routine clinical practice for the treatment of patients suffering from narcolepsy with cataplexy. A quarter of patients experience SEs requiring withdrawal of the drug with older patients being more vulnerable to the more serious SEs.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.