预约演示
更新于：2025-10-24
Sodium Oxybate
羟丁酸钠
更新于：2025-10-24
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2002-07-17), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚) |
登录后查看时间轴
结构/序列
分子式C4H8NaO3 |
InChIKeyWFBCFGRDCIMEAM-UHFFFAOYSA-N |
CAS号502-85-2 |
关联
69
项与 羟丁酸钠 相关的临床试验NCT07041203
Central Mechanisms and Treatment Response of Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor
NCT06950281
Low Sodium Oxybate Use for Nocturnal Cluster Headache: Safety, Efficacy and Tolerability of JZP-258 (XYWAV) - a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Bi-center Study.
NCT06809803
Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children
100 项与 羟丁酸钠 相关的临床结果
登录后查看更多信息
100 项与 羟丁酸钠 相关的转化医学
登录后查看更多信息
100 项与 羟丁酸钠 相关的专利（医药）
登录后查看更多信息
4,143
项与 羟丁酸钠 相关的文献（医药）2025-12-01Sleep medicine: X
Comparative efficacy of sodium oxybate versus placebo on improvement of nighttime sleep in adult patients with narcolepsy: A systematic review and meta-analysis
Review
作者: Zahoor, Hafiz Shahbaz ; Arshad, Adina ; Fatima, Anfal ; Nazakat, Ayesha ; Iqbal, Javed ; Masood, Muhammad Abdullah ; Qureshi, Muhammad Abdul Muqtadir
Background:
Narcolepsy, a central hypersomnolence disorder, disrupts sleep regulation. Sodium oxybate, a CNS (central nervous system) depressant, is widely used as a treatment, but there are surprisingly very few rigorous studies comparing its effectiveness to placebo in adults.
Objectives:
To measure the comparative efficacy of sodium oxybate at a dosage regimen of 9 g versus placebo in improving nighttime sleep quality, reducing nocturnal arousals and sleep stage shifts, and enhancing the overall refreshed nature of sleep in adult patients with narcolepsy.
Methods:
The methodology included a literature review of PubMed, Cochrane, Scopus, Google Scholar, and Clinicaltrials.gov, retrieving 53 randomized controlled trials (RCT) after removing 14 duplicates. Four studies met the criteria for gauging the efficacy of sodium oxybate compared to placebo in the adult population with narcolepsy. The primary efficacy outcome was improved sleep quality, whereas secondary outcomes were reduced nocturnal arousals and sleep stage shifts with an overall refreshed sleep nature. Analyses used RevMan 5.3 software, and SMD (standardized mean differences) with 95 % CI (confidence intervals) were calculated. Risk and publication biases were measured with Cochrane risk of bias tools and Comprehensive Meta-Analysis Software. Evidence certainty was measured using GRADEpro.
Results:
Four RCT involving 1079 participants were analyzed for said outcomes, and relevant forest plots were generated. Statistical analysis showed a substantial improvement in sleep quality [SMD = 0.74(95%Cl:0.53,0.95; p < 0.00001; I2 = 0 %; (high certainty)] and refreshing nature of sleep [SMD = 0.81(95%CI:0.51,1.11; P < 0.00001; I2 = 0 %; (moderate certainty)], reduction in nocturnal arousals [SMD = -0.62(95%CI: 0.92,-0.32; p < 0.00001; I2 = 0 %; (moderate certainty)] and sleep stage shifts [SMD = -1.22(95%CI: 1.46,-0.98; p < 0.00001; I2 = 0 %; (high certainty)]. The risk of bias was located high for one study. Symmetrical funnel plots and Egger's regression intercepts testified to no significant publication bias.
Conclusions:
The results showed that sodium oxybate considerably improved the quality of nocturnal sleep, resulting in substantial restorative advantages as well as a decrease in nocturnal arousals and sleep stage transitions. Significant results with low heterogeneity and p-values <0.05, showing consistent effects, were obtained from the analysis. However, overall reliability may be impacted by a high risk of bias in one study.
2025-11-01EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
The role of prescribed opioids in Norwegian overdose deaths in 2005–2021
Article
作者: Clausen, Thomas ; Bogstrand, Stig Tore ; Edvardsen, Hilde Marie Erøy ; Skurtveit, Svetlana
Abstract:
Purpose:
Pharmaceutical opioids significantly contribute to overdose deaths in Norway. This study investigated the prevalence of prescriptions and examined characteristics of those with filled prescriptions, comparing them to individuals without prescriptions.
Methods:
This cohort study encompassed overdose deaths from 1.1.2005 to 31.12.2021, using toxicology and data linkage from nationwide health registries. Approximately 90% of Norwegian forensic autopsy cases were linked to the Norwegian Cause of Death Registry and the Norwegian Prescribed Drug Registry. The study included cases with overdose as cause of death, as defined by the European Union Drugs Agency (EUDA), along with benzodiazepine- and GHB-induced deaths (N = 3764). Detection and filled prescription of oxycodone, codeine, buprenorphine, methadone, tramadol, and fentanyl were studied.
Results:
Fentanyl had the lowest proportion of filled prescriptions prior to death (27%), whereas codeine had the highest (67%). Buprenorphine and methadone, primary medications used in opioid agonist treatment (OAT) in Norway, showed low rates of filled prescriptions (33% and 29%, respectively). Women and older adults exhibited a higher prevalence of filled prescriptions compared to men and younger individuals. More than half of the individuals with prescribed opioids also had benzodiazepines prescribed and/or in their blood prior to death.
Conclusion:
A substantial proportion of the deceased had filled prescriptions for opioids, indicating that medical treatment might be a crucial source for these substances in overdose deaths. Additionally, poly-drug use was common, especially opioids and benzodiazepines, highlighting the need for prescribers to be cautious.
2025-10-01JOURNAL OF SLEEP RESEARCH
Present and Future of Central Disorders of Hypersomnolence
Review
作者: Dauvilliers, Yves ; Plazzi, Giuseppe ; Barateau, Lucie ; Biscarini, Francesco ; Pizza, Fabio
ABSTRACT:
Central disorders of hypersomnolence (CDH) are rare neurological conditions lumped by excessive daytime sleepiness (EDS) as primary complaint mostly arising at young age, including narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and Kleine‐Levin syndrome (KLS). Advances in clinical and translational research have deepened our understanding of NT1, particularly the loss of hypothalamic hypocretin/orexin‐producing neurons, establishing hypocretin deficiency as a reliable disease specific biomarker, although the exact mechanisms of neuronal loss remain unknown. Conversely, the pathophysiological mechanisms underlying NT2, IH, and KLS are still poorly understood, as well as their natural course. Standard diagnostic evaluation primarily relies on clinical symptoms, polysomnography and the multiple sleep latency test, with alternative neurophysiological markers (long term polysomnographic recordings), quantitative signal analysis, and wearables technologies being explored as potential innovative tools. Management remains symptomatic, combining pharmacological treatments such as stimulants, sodium oxybate, and emerging hypocretin/orexin receptor agonists, with nonpharmacological strategies tailored to improve patient quality of life. Notably, new therapies targeting orexin signalling offer promising avenues for transforming treatment approaches, particularly in NT1. Looking ahead, advancing precision medicine approaches and addressing unmet needs in CDH are essential to improve patient outcomes. This review summarises current knowledge and highlights future research directions in CDH pathophysiology, diagnostic approaches and pharmacological management.
100 项与 羟丁酸钠 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 猝倒症 | 欧盟 | 2005-10-13 | |
| 猝倒症 | 冰岛 | 2005-10-13 | |
| 猝倒症 | 列支敦士登 | 2005-10-13 | |
| 猝倒症 | 挪威 | 2005-10-13 | |
| 发作性睡病 | 美国 | 2002-07-17 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 戒酒 | 申请上市 | 欧盟 | 2019-10-17 | |
| 物质戒断综合征 | 申请上市 | 欧盟 | 2019-10-17 | |
| 特发性睡眠过度 | 临床3期 | 美国 | 2024-08-01 | |
| 白天过度嗜睡 | 临床3期 | 美国 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 澳大利亚 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 加拿大 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 捷克 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 法国 | 2016-11-17 | |
| 白天过度嗜睡 | 临床3期 | 德国 | 2016-11-17 | |
| 暴食症 | 临床3期 | 美国 | 2007-08-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | - | 壓憲壓繭艱壓選壓製壓(衊觸艱鹽窪製醖餘範鹹): P-Value = 0.522 更多 | 积极 | 2025-04-07 | |||
Placebo | |||||||
临床3期 | 89 | 築醖壓憲願壓積網鹽窪(糧鏇觸蓋壓鬱齋積築鹽) = 繭範觸餘鹹觸夢遞鏇膚 壓選築鹹選糧獵獵艱鏇 (繭願壓糧憲蓋觸選衊憲 ) 更多 | 积极 | 2025-04-07 | |||
Literature 人工标引  | 临床2期 | 106 | (EtOH+) | 築廠鏇構廠艱壓夢選鏇(範鹽餘艱網蓋齋衊鑰獵) = 醖衊簾廠蓋鑰淵鬱衊齋 餘願網憲艱糧鹹鏇鹹壓 (鬱選醖餘鬱積鬱觸鏇願 ) | 积极 | 2024-11-20 | |
(EtOH-) | - | ||||||
临床3期 | 212 | 糧簾鬱鹽壓觸糧範觸範(艱簾壓鬱膚鹹觸觸鏇遞) = 醖夢糧觸壓繭窪蓋淵製 觸膚網夢製壓壓顧積淵 (鏇糧壓網廠糧遞膚膚齋 ) 更多 | 积极 | 2024-08-20 | |||
Placebo | 糧簾鬱鹽壓觸糧範觸範(艱簾壓鬱膚鹹觸觸鏇遞) = 壓製鬱淵顧製繭蓋糧鑰 觸膚網夢製壓壓顧積淵 (鏇糧壓網廠糧遞膚膚齋 ) 更多 | ||||||
临床3期 | - | 艱衊願衊窪壓獵蓋鏇鏇(衊積觸糧繭膚鬱糧齋壓) = 範襯鑰簾餘膚選網範窪 窪鹽廠選衊淵築觸齋鹹 (鑰鏇遞膚襯鬱鬱鹹夢襯, 0.13) 更多 | 积极 | 2024-08-16 | |||
Placebo | 艱衊願衊窪壓獵蓋鏇鏇(衊積觸糧繭膚鬱糧齋壓) = 製鑰淵遞齋醖築範築淵 窪鹽廠選衊淵築觸齋鹹 (鑰鏇遞膚襯鬱鬱鹹夢襯, 0.13) 更多 | ||||||
早期临床1期 | - | 180 | Sodium oxybate (30 mg kg<sup>-1</sup>) | 鑰鑰積糧鏇憲艱糧顧遞(顧鹹窪選憲顧窪顧蓋膚) = 膚蓋淵襯夢構壓範憲範 獵鑰鏇餘鹽淵鹽壓範遞 (糧齋襯餘鹽製鹹積齋觸, 2 ~ 16) | 积极 | 2024-05-01 | |
N/A | - | - | 顧淵鹽顧艱網齋鹽範觸(齋願顧積壓築窪蓋艱壓) = rate of discontinuations owing to AEs in the weight-loss group was half that of the ON-SXB group without weight loss (10.5% vs 21.1%, respectively) 艱獵淵鹽積構鹹顧艱製 (窪獵淵顧遞淵範淵醖鹹 ) 更多 | - | 2023-10-24 | ||
Placebo | |||||||
临床3期 | - | 184 | ON-SXB 4.5 g/night | 鬱夢壓糧蓋廠壓夢獵獵(製鏇鹽壓廠範膚醖蓋選) = 5.6% 積選膚蓋鏇製製構夢憲 (鑰範壓積襯構衊醖糧夢 ) 更多 | 积极 | 2023-10-23 | |
ON-SXB 7.5 g/night | |||||||
N/A | - | 夢範積艱艱糧鏇鬱憲範(網艱範齋獵壓製獵艱壓) = 憲範廠構選築鬱製築鹹 壓願膚鬱廠淵糧鏇顧鹹 (餘繭網構鏇製構壓艱壓 ) | - | 2023-10-23 | |||
N/A | - | 遞衊廠鏇廠鏇壓齋襯選(鏇廠壓膚醖獵鬱積窪襯) = most common adverse drug reactions: dizziness 壓衊壓糧築繭齋膚築醖 (觸衊積衊獵構鑰獵築範 ) 更多 | - | 2023-10-23 | |||
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用