sodium oxybate / Generic mfg. - LARVOL DELTA

Extended-release Sodium Oxybate in Children (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Stanford University | Initiation date: Jul 2025 ➔ Oct 2025

Trial initiation date • Narcolepsy • Sleep Disorder

Patient Perceptions of and Experiences with Risk Evaluation and Mitigation Strategies. (PubMed, Clin Pharmacol Ther) - "To understand patients' and caregivers' perception of and experiences with REMS programs with elements to assure safe use, we conducted semi-structured interviews from March 2022 to July 2023 with 135 patients or caregivers of patients who had used alemtuzumab (Lemtrada), ambrisentan (Letairis), clozapine (Clozaril), isotretinoin (Accutane), lenalidomide (Revlimid), pegvaliase (Palynziq), or sodium oxybate (Xyrem/Xywav). Among 135 participants, five key themes emerged: (1) Participants were knowledgeable about REMS-associated drug risks and requirements; (2) some participants had difficulty finding prescribers, particularly for clozapine; (3) administrative burdens related to REMS implementation were a source of frustration, with satisfaction higher when care coordination support was provided; (4) emotional and logistical challenges were identified with pregnancy- and clozapine-related testing; and (5) participants desired similar engagement around risks not..."

Journal

Effect of Narcolepsy and Idiopathic Hypersomnia on Relationships: A Social Media Analysis (WSS 2025) - "Across all conversations that mentioned both sleeping and a partner, the most common topics identified were sleep medication usage, narcolepsy journey, Xyrem/Xywav, falling asleep, medical diagnosis journey, and vivid dreaming. These data suggest that nighttime sleep symptoms, including parasomnias, may be a source of concern within relationships of people with narcolepsy or IH. Sleepiness and bed sharing with a partner with narcolepsy or IH may cause relationship tension given the strong association with emotions with a negative connotation, such as anger and frustration."

Behavior Disorders • CNS Disorders • Mental Retardation • Narcolepsy • Psychiatry • Sleep Disorder

Impact of Switching From High- to Low-Sodium Oxybate on Ambulatory Blood Pressure in People With Narcolepsy (WSS 2025) - P4 | "Materials and XYLO, an open-label, single-arm study (NCT05869773), evaluated people with narcolepsy aged 18−70 years with screening systolic blood pressure (SBP) 130−155 mmHg taking twice-nightly high-sodium oxybate (SXB; Xyrem®) 6–9 g for ≥6 weeks, switching to low-sodium oxybate (LXB; Xywav®) at the same dosage/regimen for ≈6 weeks. Switching from SXB to LXB reduced daily treatment-related sodium intake in participants with narcolepsy and was associated with clinically meaningful BP reductions, consistent with evidence on dietary sodium effects."

Cardiovascular • Hypertension • Narcolepsy • Sleep Disorder

Challenges in the Treatment of Narcolepsy and the Positive Impact of Acetyl-L-Carnitine: A Case-Based Review with 20-Year Follow-Up (WSS 2025) - "Initial pharmacologic management included antidepressants, Modafinil, Armodafinil, Adderall, Concerta, Jornay, Vyvanse, and sodium oxybate (Xyrem). This case highlights the multifaceted challenges in narcolepsy management and proposes acetyl-L-carnitine as a potential adjuvant therapy in refractory cases. Given its safety profile and observed benefit in this case, ALCAR warrants further investigation through controlled clinical trials."

Clinical • Review • Barrett Esophagus • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Gastrointestinal Disorder • Mental Retardation • Metabolic Disorders • Mood Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Extended-release Sodium Oxybate in Children (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Stanford University | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2027 ➔ Jul 2027 | Initiation date: Feb 2025 ➔ Jul 2025 | Trial primary completion date: Jan 2027 ➔ Jun 2027

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Narcolepsy • Sleep Disorder

The Role of Barbiturates in GHB Withdrawal: A Literature Review and Case Presentation Using Phenobarbital for Severe Sedative Withdrawal (APA 2025) - "Case: A 31-year-old woman with narcolepsy, managed with chronic GHB (Xyrem), presented with severe insomnia, mania, and psychosis after abruptly discontinuing her medication. Despite treatment with high-dose benzodiazepines (approximately 100 mg diazepam equivalent in 24 hours), her symptoms worsened, progressing to an oneiroid state, necessitating ICU admission... This review adds to sparse literature on summative recommendations for the management of GHB withdrawal. The presence of psychotic symptoms or delirium (disorientation, impaired attention and arousal) should raise suspicion for severe GHB withdrawal requiring immediate intervention. While mild to moderate cases of GHB withdrawal may be treated with baclofen and benzodiazepines as is recommended, we advise providers treating severe cases of GHB withdrawal should maintain a low clinical threshold for treatment escalation to ICU admission and phenobarbital administration."

Clinical • Review • Addiction (Opioid and Alcohol) • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Insomnia • Mood Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Extended-release Sodium Oxybate in Children (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Stanford University

New P2 trial • Narcolepsy • Sleep Disorder

Initial evaluation of 4-palmitoyloxy butyrate in whole blood as potential biomarker after γ-hydroxybutyric acid intake. (PubMed, J Anal Toxicol) - "Whole blood samples were collected from subjects involed in police roadside controls (n=113) and from narcolepsy patients (n=10) after the controlled administration of Xyrem® (sodium oxybate)...Furthermore, GHB-Pal was only detectable at a GHB concentration of at least 16 µg/mL, which indicates that endogenous concentrations or low GHB doses may not be sufficient for GHB-Pal formation. Due to missing correlation between both compounds and the lack of GHB-Pal detection several hours after GHB administration, it can be assumed that GHB-Pal in blood is not a suitable biomarker to widen the detection window of GHB."

Biomarker • Journal • Narcolepsy • Sleep Disorder

EFFICACY OF LOW-SODIUM OXYBATE IN NARCOLEPSY PATIENTS WITH AND WITHOUT CARDIOVASCULAR OR CARDIOMETABOLIC DISORDERS (SLEEP 2024) - P3 | "Introduction: Low-sodium oxybate (LXB; Xywav®) is approved by the US Food and Drug Administration to treat excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy, and idiopathic hypersomnia in adults. LXB con tains the same active moiety as high-sodium oxybates (sodium oxybate [SXB, Xyrem®] and fixed-dose SXB [Lumryz™]) but with 92% less sodium... In this post-hoc analysis, the efficacy and safety of LXB were similar in participants with narcolepsy with and with out CV/CM comorbidities."

Clinical • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Avadel Pharmaceuticals Shares New LUMRYZ (sodium oxybate) For Extended-release Oral Suspension (CIII) Data at SLEEP 2024 (GlobeNewswire) - "Avadel Pharmaceuticals plc...announced today it will present 11 posters, and one oral presentation, supporting the use of LUMRYZ as a narcolepsy treatment option at SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society on June 1-5, 2024, in Houston."

Clinical data • CNS Disorders • Narcolepsy

Effectiveness and optimization of low-sodium oxybate in participants with narcolepsy switching from a high-sodium oxybate: data from the SEGUE study. (PubMed, J Clin Sleep Med) - P4 | "Most participants switched from SXB to LXB with minimal modifications of dose/regimen and reported the transition process was easy. Effectiveness of oxybate treatment was maintained on LXB, and most participants preferred LXB to SXB. No new safety or tolerability issues were identified."

Journal • Cardiovascular • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Effectiveness and Optimization of Low-sodium Oxybate in Participants with Narcolepsy Switching from Sodium Oxybate: Final Data from the Substitution of Equal Grams of Uninterrupted Xyrem to Xywav (SEGUE) Study (AAN 2024) - "Most participants with narcolepsy switched from SXB to LXB with minimal modifications of dose/regimen and reported the transition process was easy. Effectiveness of oxybate treatment (ESS) was maintained after transition, and most preferred LXB over SXB."

Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Effects of Oxybate on Sleep, Sleep Architecture, and Disrupted Nighttime Sleep (AAN 2024) - "Sodium oxybate (SXB; Xyrem®), dosed twice nightly, is approved to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. Once-nightly sodium oxybate (ON-SXB; Lumryz™) and low-sodium oxybate (Xywav®) have been approved for the same indication...A clinical data review shows that oxybate, independent of once- or twice-nightly dosing, is effective in improving sleep, measures of sleep architecture, and DNS in participants with narcolepsy."

Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Pediatrics • Sleep Disorder

Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients with Narcolepsy: A Commentary. (PubMed, Neurol Ther) - "Sodium oxybate (SXB; Xyrem), administered twice nightly, is indicated for the treatment of cataplexy and excessive daytime sleepiness in patients 7 years or older with narcolepsy. Recently, low-sodium oxybate (LXB, Xywav; for people 7 years of age and older), which contains 92% less sodium than SXB and is dosed twice nightly, and sodium oxybate for extended release (SXB-ER; Lumryz™; for adults), which contains equal sodium to SXB and is dosed once nightly, have also been approved to treat cataplexy or excessive daytime sleepiness in narcolepsy...Additionally, for SXB, but not SXB-ER, polysomnographic data has been analyzed by half of the night, demonstrating a greater positive impact on sleep architecture in the second half of the night, which might be related to its nonlinear pharmacokinetic profile. We conclude that while once-nightly and twice-nightly oxybate dosing regimens differ in their pharmacokinetic profiles, both improve DNS in patients with..."

Journal • Cataplexy • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Narcolepsy • Pediatrics • Sleep Disorder

Individualized dosing strategies for oxybate: Insights from the real-world TENOR study (WSS 2023) - P=N/A | "Introduction:Low-sodium oxybate (LXB; Xywav®) contains the same active moiety as high-sodium oxybates (sodium oxybate [SXB; Xyrem®] and fixed-dose, high-sodium oxybate [Lumryz™]), but with 92% less sodium, and is approved by the US Food and Drug Administration (FDA) for treating cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. Data from this real-world study demonstrate dosing strategies for oxybate individualization, including reasons for considering unequal twice-nightly dosing. The most common reasons reported for unequal dosing were to avoid morning grogginess and to help fall asleep. These real-world insights may help inform clinical decision around individualizing dosing strategy in patients with narcolepsy.Acknowledgements: Medical writing and editorial support was provided by Shawn Jaramillo, PharmD, OPEN Health, Parsippany, NJ, and funded by Jazz Pharmaceuticals."

Clinical • Real-world • Real-world evidence • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Insomnia • Mood Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Amneal Launches Authorized Generic for Xyrem (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter (Businesswire) - "Amneal Pharmaceuticals, Inc...announced the launch of its authorized generic for Xyrem® (Sodium Oxybate) oral solution CIII in the United States. Sodium Oxybate oral solution, 0.5 g/mL is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. In addition, the Company announced it has received Abbreviated New Drug Application (ANDA) approvals from the U.S. Food and Drug Administration ('FDA') for five complex generics products. Three recently approved products are injectables, including Xyrem injection which is currently on the U.S. FDA shortage product list...Medroxyprogesterone acetate Injectable suspension, USP 150mg/mL (1mL); Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL); Nelarabine injection, 250mg/50mL (5mg/mL); Dapsone 7.5% gel; Mometasone furoate nasal spray, 50 mcg."

ANDA • Generic launch • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Excessive Daytime Sleepiness in Narcolepsy • Narcolepsy • Sleep Disorder

Patient Experiences With Sodium Oxybate Therapy for Narcolepsy: A Social Listening Analysis (SLEEP 2023) - "Using a clinical entity recognition tagger, leveraging medicine ontology, conversations were filtered by mentions of (1) second dosage (e.g., second dose, 2nd) and (2) sodium oxybate (e.g., Xyrem, SO) to build a co-occurrence network for conversations discussing second doses of SO...Conclusion The second nightly SO dose is associated with sleep-related issues for people with narcolepsy and their caregivers. Both the SL analysis and survey revealed that a missed/delayed second dose of SO decreased daily functioning, quality of life, and physical health."

Clinical • CNS Disorders • Depression • Narcolepsy • Pain • Psychiatry • Sleep Disorder

Effectiveness and Optimization of Lower-Sodium Oxybate in Participants With Narcolepsy Switching From Sodium Oxybate (SEGUE) (SLEEP 2023) - "Introduction Lower-sodium oxybate (LXB, Xywav®) contains 92% less sodium than higher-sodium oxybate (SXB, Xyrem®) and is approved for treating cataplexy or excessive daytime sleepiness in patients with narcolepsy (≥7 years of age) and idiopathic hypersomnia in adults. Conclusion Most participants with narcolepsy switched from SXB to LXB with minimal modifications of dose/regimen and reported the transition process was easy. Effectiveness of oxybate treatment (ESS) was maintained after transition, and most preferred LXB over SXB."

Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Patient-Reported Sleep Quality in People With Narcolepsy Transitioning From Sodium Oxybate to Lower-Sodium Oxybate (SLEEP 2023) - P=N/A | "Supported By Jazz Pharmaceuticals Introduction Lower-sodium oxybate (LXB; Xywav®), which contains the same active moiety as higher-sodium oxybate (SXB; Xyrem®) but with 92% less sodium, is approved by the US Food and Drug Administration (FDA) for treating cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. Conclusion Although participant-reported sleep quality was generally unchanged during the study, a greater percentage of participants reported feeling refreshed at end of study (on LXB) than at baseline (on SXB); however, there was no non-transitioning arm for comparison. Small changes were noted at end of study in sleep parameters, including sleep latency, WASO, and TST."

Clinical • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Treatment Satisfaction and Preferences in People With Narcolepsy Transitioning From Sodium Oxybate to Lower-Sodium Oxybate (SLEEP 2023) - P=N/A | "Supported By Jazz Pharmaceuticals Introduction Lower-sodium oxybate (LXB; Xywav®), which contains the same active moiety as higher-sodium oxybate (SXB; Xyrem®) but with 92% less sodium, is approved by the US Food and Drug Administration (FDA) for treating cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy. Conclusion Overall, most participants indicated that switching from SXB to LXB was “easy” or “extremely easy.” Most participants preferred LXB to SXB, primarily because of its lower sodium content. Satisfaction with oxybate treatment was maintained following transition to LXB."

Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

"Lumryz from Avadel Pharmaceuticals plc (@AvadelPharma): About 30% of Neuros highlighted the comparison between Lumryz and Xyrem / Xywav in terms of dosing convenience, patient compliance, sodium content, and the potential for Lumryz to replace Xyrem / Xywav (@JazzPharma ) (3/n)" (@ZoomRx)

Clinical • Compliance

Effects of sodium oxybate on hypocretin/orexin and locus coeruleus neurons. (PubMed, Sleep) - "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."

Journal • Cataplexy • Narcolepsy • Sleep Disorder

Effectiveness and Optimization of Low-Sodium Oxybate in Participants With Narcolepsy Switching From High-Sodium Oxybate: Interim Data from the Substitution of Equal Grams of Uninterrupted Xyrem to Xywav (SEGUE) Study (AAN 2023) - P4 | "Conclusions Participants switched from SXB to LXB with minimal modifications of dose/regimen and reported the transition was easy. Efficacy of oxybate treatment was maintained or improved, and most participants preferred LXB over SXB."

Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

"A little article on the recent appellate ruling against ⁦@JazzPharma⁩ via @NYTimes #sleep #narcolepsy #xyrem #xywav https://t.co/C47WSbdTe3" (@BrandonPetersMD)

Narcolepsy • Sleep Disorder