Jazz Pharmaceuticals在Sleep 2024上展示了睡眠医学的先驱研究-动脉网

Jazz Pharmaceuticals Showcases Pioneering Research in Sleep Medicine at SLEEP 2024

CISION 等信源发布 2024-05-30 19:30

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Thirteen abstracts, including five late-breaking abstracts, underscore Jazz's ongoing commitment to advancing the understanding and treatment of serious sleep disorders

十三篇摘要，包括五篇最新的摘要，强调了Jazz对促进对严重睡眠障碍的理解和治疗的持续承诺

Oral presentation of XYLO study design to assess systolic blood pressure changes in oxybate patients after switching to low-sodium Xywav®

口服XYLO研究设计，以评估转换为低钠Xywav®后oxybate患者的收缩压变化

DUBLIN, May 30, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that thirteen abstracts, including five late-breaking abstracts, featuring new data from across its sleep medicine portfolio will be presented at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies being held June 1-5, 2024, in Houston, Texas..

都柏林，2024年5月30日/PRNewswire/--Jazz Pharmaceuticals plc（纳斯达克：Jazz）今天宣布，将在2024年6月1日至5日于德克萨斯州休斯顿举行的第38届睡眠专业协会年会sleep 2024上发表13篇摘要，其中包括5篇最新摘要，其中包含来自其睡眠医学组合的新数据。。

Two abstracts were selected for oral presentations, including one that showcases the design elements from the Phase 4 XYLO study, which measures changes in 24-hour average systolic blood pressure after switching to low-sodium oxybate, Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution from a high-sodium oxybate oral solution in patients with narcolepsy.

选择了两篇摘要进行口头演示，其中一篇展示了第4阶段XYLO研究的设计元素，该研究测量了发作性睡病患者改用低羟丁酸钠，Xywav®（钙，镁，钾和羟丁酸钠）口服溶液后24小时平均收缩压的变化。

An additional oral presentation describes a post-hoc analysis of Xywav efficacy and safety data in patients with narcolepsy with or without a medical history of psychiatric and/or neurologic comorbidities, which found that the efficacy and safety of Xywav was similar among the two groups..

另一篇口头报告描述了对有或没有精神病和/或神经系统合并症病史的发作性睡病患者的Xywav疗效和安全性数据的事后分析，发现Xywav的疗效和安全性在两组之间相似。。

'For nearly two decades, we have been dedicated to advancing and delivering patient-centric solutions for those living with serious conditions, such as narcolepsy and idiopathic hypersomnia, which are chronic, debilitating neurologic sleep disorders that often require lifelong treatment,' said Kelvin Tan, MB BCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals.

Jazz Pharmaceuticals高级副总裁兼首席医疗官Kelvin Tan（MB BCh，MRCPCH）说：“近二十年来，我们一直致力于为那些患有严重疾病（如嗜睡症和特发性嗜睡）的人提供以患者为中心的解决方案，这些疾病是一种慢性的、使人衰弱的神经系统睡眠障碍，通常需要终身治疗。”。

'I am proud of the range of data being presented at SLEEP 2024, which continues to demonstrate our commitment to the sleep community and the importance of addressing the needs of patients with these multi-symptom, and often underrecognized, sleep disorders.'.

“我为在2024年睡眠会议上提供的一系列数据感到骄傲，这些数据继续证明了我们对睡眠社区的承诺，以及解决这些多症状且往往未被充分认识的睡眠障碍患者需求的重要性。”。

Additional highlights at SLEEP 2024 include:

SLEEP 2024的其他亮点包括：

Two late-breaking poster presentations, which utilized the U.S. National Health and Wellness Survey data to assess the burden experienced by patients with idiopathic hypersomnia. One analysis examined the clinical and humanistic burden on U.S. adults with idiopathic hypersomnia, which demonstrates the substantial comorbidity and health-related quality-of-life burden that patients experience.

两张最新的海报展示，利用美国国家健康与健康调查数据评估特发性嗜睡患者的负担。一项分析检查了美国成年人特发性嗜睡的临床和人文负担，这表明患者经历了严重的合并症和与健康相关的生活质量负担。

The second analysis examined the healthcare resource utilization and medical costs for U.S. adults with idiopathic hypersomnia, which found patients reported significantly greater economic burden, including work productivity, compared to those without idiopathic hypersomnia..

第二项分析检查了美国特发性嗜睡成年人的医疗资源利用率和医疗费用，发现与没有特发性嗜睡的患者相比，患者报告的经济负担（包括工作效率）明显更大。。

Four posters, including two late-breaking abstracts, showcase design elements and baseline characteristics of participants (enrolled as of February 5, 2024) in the Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment (DUET) study. The DUET study is a Phase 4, prospective study to assess the effect of Xywav treatment on excessive daytime sleepiness, polysomnography parameters, and functional outcomes in adults with idiopathic hypersomnia or narcolepsy..

四张海报，包括两篇最新摘要，展示了参与者（截至2024年2月5日登记）的设计元素和基线特征，通过评估低羟丁酸钠治疗（DUET）研究来了解嗜睡。DUET研究是一项4期前瞻性研究，旨在评估Xywav治疗对特发性嗜睡或嗜睡症成年人白天过度嗜睡，多导睡眠图参数和功能结局的影响。。

A poster describing a post-hoc analysis of a Phase 3 trial assessing the efficacy and safety of Xywav in participants with narcolepsy with and without cardiovascular or cardiometabolic comorbidities. The analysis demonstrates similar efficacy and safety of Xywav in participants with narcolepsy with and without these comorbidities..

一张海报描述了对3期试验的事后分析，该试验评估了Xywav在有或没有心血管或心脏代谢合并症的发作性睡病患者中的疗效和安全性。分析表明，Xywav在有或没有这些合并症的发作性睡病患者中具有相似的疗效和安全性。。

The SLEEP 2024 abstracts are available online at the following link: https://academic.oup.com/sleep/issue/47/Supplement_1.

睡眠2024摘要可通过以下链接在线获得：https://academic.oup.com/sleep/issue/47/Supplement_1.

A full list of Jazz presentations follows:

爵士乐演讲的完整列表如下：

Presentation Title

演示文稿标题

Lead Author

主要作者

Presentation Number / Session / Date & Time (CT)

演示编号/会话/日期和时间（CT）

Dual Presentations

双重演示

Design Elements for a Switch Study From High- to Low-Sodium Oxybate Evaluating Blood Pressure in Narcolepsy (XYLO)

从高到低羟丁酸钠转换研究的设计元素评估发作性睡病（XYLO）的血压

V Somers

在萨默斯

Oral Session: O-18 Oral Presentation Date/Time: Tuesday, June 4, 4:30-4:45 PM Poster Number: 259 Poster Session: P-13 Poster Presentation Date/Time: Monday, June 3, 10:00-10:45 AM

口头会议：O-18口头报告日期/时间：6月4日星期二下午4:30-4:45海报编号：259海报会议：P-13海报报告日期/时间：6月3日星期一上午10:00-10:45

Efficacy and Safety of Low-Sodium Oxybate in Narcolepsy Patients With/Without Psychiatric/Neurologic Comorbidities

低羟丁酸钠治疗有/无精神/神经系统合并症的发作性睡病患者的疗效和安全性

C Chepke

C切普克

Oral Session: O-18 Oral Presentation Date/Time: Tuesday, June 4, 4:45-5:00 PM Poster Number: 263 Poster Session: P-13 Poster Presentation Date/Time: Monday, June 3, 10:00-10:45 AM

口头会议：O-18口头报告日期/时间：6月4日星期二下午4:45-5:00海报编号：263海报会议：P-13海报报告日期/时间：6月3日星期一上午10:00-10:45

Poster Presentations

墙报交流

Efficacy of Low-Sodium Oxybate in Narcolepsy Patients With and Without Cardiovascular or Cardiometabolic Disorders

低羟丁酸钠治疗发作性睡病伴或不伴心血管或心脏代谢紊乱患者的疗效

BC Corser

Poster Number: 264 Poster Session: P-13 Poster Presentation Date/Time: Monday, June 3, 11:00-11:45 AM

海报编号：264海报会议：P-13海报展示日期/时间：6月3日星期一上午11:00-11:45

Population Pharmacokinetic and Exposure-Response Analyses Supporting Individualized Dosing of Oxybate

支持个体化服用羟丁酸酯的人群药代动力学和暴露反应分析

C Chen

C陈

Poster Number: 256 Poster Session: P-13 Poster Presentation Date/Time: Monday, June 3, 11:00-11:45 AM

海报编号：256海报会议：P-13海报展示日期/时间：6月3日星期一上午11:00-11:45

Supporting Patient Safety With Oxybate Therapy: A Survey of Patients and Prescribers

用羟丁酸酯治疗支持患者安全：对患者和处方者的调查

S Candler

S烛台

Poster Number: 265 Poster Session: P-13 Poster Presentation Date/Time: Monday, June 3, 10:00-10:45 AM

海报编号：265海报会议：P-13海报展示日期/时间：6月3日星期一上午10:00-10:45

Long-term Safety and Timing of Adverse Events With Low-Sodium Oxybate in a Phase 3 Idiopathic Hypersomnia Study

在3期特发性嗜睡研究中，低羟丁酸钠不良事件的长期安全性和发生时间

RK Bogan

移动RK

Poster Number: 254 Poster Session: P-13 Poster Presentation Date/Time: Monday, June 3, 11:00-11:45 AM

海报编号：254海报会议：P-13海报展示日期/时间：6月3日星期一上午11:00-11:45

A Qualitative Exploration of Patient and Healthcare Provider Perspectives on Oxybate Treatments for Narcolepsy

定性探索患者和医疗保健提供者对羟丁酸治疗发作性睡病的观点

S Candler

S烛台

Poster Number: 407 Poster Session: P-31 Poster Presentation Date/Time: Tuesday, June 4, 10:00-10:45 AM

海报编号：407海报会议：P-31海报展示日期/时间：6月4日星期二上午10:00-10:45

Baseline Features of Participants With Narcolepsy: Insights From the DUET Study

发作性睡病参与者的基线特征：来自DUET研究的见解

A Cairns

凯恩斯

Poster Number: 437 Poster Session: P-31 Poster Presentation Date/Time: Tuesday, June 4, 10:00-10:45 AM

海报编号：437海报会议：P-31海报展示日期/时间：6月4日星期二上午10:00-10:45

Baseline Features of Participants With Idiopathic Hypersomnia: Insights From the DUET Study

特发性嗜睡参与者的基线特征：来自DUET研究的见解

D Plante

D植物

Poster Number: 432 Poster Session: P-31 Poster Presentation Date/Time: Tuesday, June 4, 11:00-11:45 AM

海报编号：432海报会议：P-31海报展示日期/时间：6月4日星期二上午11:00-11:45

The Clinical and Humanistic Burden of Idiopathic Hypersomnia in the United States: Analysis of the National Health and Wellness Survey

美国特发性嗜睡的临床和人文负担：国家健康与福祉调查分析

DT Plante

DT工厂

Poster Number: 434 Poster Session: P-31 Poster Presentation Date/Time: Tuesday, June 4, 11:00-11:45 AM

海报编号：434海报会议：P-31海报展示日期/时间：6月4日星期二上午11:00-11:45

The Economic Burden of Idiopathic Hypersomnia in the United States: Analysis of the National Health and Wellness Survey

美国特发性嗜睡的经济负担：国家健康与健康调查分析

C Drachenberg

Poster Number: 436 Poster Session: P-31 Poster Presentation Date/Time: Tuesday, June 4, 11:00-11:45 AM

海报编号：436海报会议：P-31海报展示日期/时间：6月4日星期二上午11:00-11:45

Novel Design Elements to Evaluate Sleep Architecture and Outcomes in an Idiopathic Hypersomnia and Narcolepsy Study

在特发性嗜睡和发作性睡病研究中评估睡眠结构和结果的新颖设计元素

DT Plante

DT工厂

Poster Number: 283 Poster Session: P-42 Poster Presentation Date/Time: Wednesday, June 5, 10:00-10:45 AM

海报编号：283海报会议：P-42海报展示日期/时间：6月5日星期三上午10:00-10:45

Patient-Centric Design: Incorporating Patient Input Into a Clinical Study of Idiopathic Hypersomnia and Narcolepsy

以患者为中心的设计：将患者输入纳入特发性嗜睡和发作性睡病的临床研究

DA Nichols

达尼科尔斯

Poster Number: 304 Poster Session: P-42 Poster Presentation Date/Time: Wednesday, June 5, 11:00-11:45 AM

海报编号：304海报会议：P-42海报展示日期/时间：6月5日星期三上午11:00-11:45

About NarcolepsyNarcolepsy is a chronic, debilitating neurologic sleep disorder characterized by excessive daytime sleepiness (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness), or EDS, and an inability to regulate sleep-wake cycles normally.1 Patients with EDS due to narcolepsy experience sleep attacks and, despite fighting the urge to sleep, may unintentionally fall asleep for short periods.2,3 These sleep attacks may happen at inappropriate or potentially dangerous times such as during driving, cycling, eating, or mid-conversation.4.

关于发作性睡病，发作性睡病是一种慢性，使人衰弱的神经系统睡眠障碍，其特征是白天过度嗜睡（白天无法保持清醒和警觉，导致无法抑制的睡眠需求或无计划的进入睡眠或嗜睡），或EDS，以及无法正常调节睡眠-觉醒周期[1]。由于发作性睡病导致的EDS患者会出现睡眠发作，尽管抵抗了睡眠的冲动，但可能会在短时间内无意入睡[2,3]。这些睡眠发作可能发生在不适当或潜在的危险时间，例如在驾驶，骑自行车，进食或谈话中。

There is no cure for narcolepsy, therefore this EDS is lifelong and has a substantial negative impact on a person's ability to function psychologically, socially and professionally.5 Patients with narcolepsy are at increased risk for hypertension, cardiometabolic morbidity, stroke, myocardial infarction, heart failure, cardiac arrest, and death.6,7,8,9 As narcolepsy is a chronic condition that requires lifelong, nightly treatment, early access to an effective, low-sodium treatment can transform lives and reduce the impact of narcolepsy on a person's physical and mental health.5.

发作性睡病无法治愈，因此这种EDS是终身的，对一个人的心理，社会和专业功能产生重大负面影响。5发作性睡病患者患高血压，心脏代谢疾病，中风，心肌梗塞，心力衰竭，心脏骤停和死亡的风险增加。6,7,8,9由于发作性睡病是一种需要终身，夜间治疗的慢性病，因此尽早获得有效的低钠治疗可以改变生活并减少发作性睡病对一个人身心健康的影响。

About Idiopathic Hypersomnia Idiopathic hypersomnia is an often debilitating, neurologic sleep disorder that goes beyond chronic excessive daytime sleepiness.10,11,12,13 Idiopathic hypersomnia is a 24-hour sleep disorder, and symptoms may include a prolonged but non-restorative main (nighttime) sleep episode of more than 9 hours, or a sleep duration of 11 hours or longer over a 24-hour period; cognitive impairment; long and unrefreshing naps; brain fog, or the inability to focus for long periods of time; and severe sleep inertia (prolonged difficulty waking, with frequent reentries into sleep, confusion, and irritability).10,11,12,13,14 Although there are overlapping clinical features with narcolepsy, idiopathic hypersomnia is a condition with its own specific diagnostic criteria.13,15 .

关于特发性嗜睡特发性嗜睡是一种经常使人衰弱的神经系统睡眠障碍，超出了慢性白天过度嗜睡的范围[10,11,12,13]。特发性嗜睡是一种24小时睡眠障碍，症状可能包括长时间但非恢复性的主要（夜间）睡眠发作超过9小时，或在24小时内睡眠时间为11小时或更长；认知障碍；长时间不休息；脑雾，或长时间无法集中注意力；和严重的睡眠惯性（长时间难以醒来，经常再次进入睡眠，混乱和易怒）[10,11,12,13,14]。虽然发作性睡病的临床特征重叠，但特发性嗜睡是一种有其特定诊断标准的疾病[13,15]。

Idiopathic hypersomnia is a debilitating illness that can significantly affect social, educational, and occupational functioning.16,17 In the U.S., approximately 37,000 adult patients have been diagnosed with idiopathic hypersomnia and are actively seeking healthcare.18 This low number of people may be due to the many difficulties in identifying and diagnosing idiopathic hypersomnia, as well as distinguishing it from other similar sleep disorders.

特发性嗜睡是一种使人衰弱的疾病，可以显着影响社会，教育和职业功能[16,17]。S、，大约37000名成年患者被诊断出患有特发性嗜睡，并正在积极寻求医疗保健[18]。这一人数少可能是由于在识别和诊断特发性嗜睡以及将其与其他类似睡眠障碍区分开来方面存在许多困难。

It is estimated that far fewer patients are currently receiving pharmacological treatment for their idiopathic hypersomnia.18,19,20,21.

据估计，目前接受特发性嗜睡药物治疗的患者少得多[18,19,20,21]。

About Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solutionXywav is a low-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.

关于Xywav®（钙，镁，钾和羟丁酸钠）口服溶液Xywav是美国批准的低羟丁酸钠。S、美国食品和药物管理局（FDA）用于治疗7岁及以上发作性睡病患者的猝倒或白天过度嗜睡（EDS）。FDA承认Xywav在7岁及以上发作性睡病患者中治疗瘫痪或EDS的孤儿药独占权为7年。

The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem® (sodium oxybate) oral solution.

美国食品和药物管理局孤儿产品开发办公室（OOPD）还发布了其关于Xywav治疗7岁及以上发作性睡病患者猝倒或EDS的临床优越性的总结，与Xyrem®（羟丁酸钠）口服溶液相比，其心血管安全性更高。

The decision of the OOPD is based on the FDA findings that Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. Xywav has 131 mg of sodium at the maximum recommended nightly dose. Xywav is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night. Xywav is the only low-sodium oxybate therapy approved by the FDA, and the only oxybate that does not carry a warning in the label related to use in patients sensitive to high sodium intake..

OOPD的决定是基于FDA的发现，即与Xyrem相比，Xywav可以大大减少慢性钠负荷。Xywav的最大推荐夜间剂量为131毫克钠。Xywav由独特的阳离子组成，可减少92%的钠，或减少约1000至1500毫克/夜。Xywav是FDA批准的唯一一种低钠羟丁酸钠疗法，也是唯一一种在标签上没有警告的羟丁酸钠，用于对高钠摄入敏感的患者。。

Xywav is also the first and only U.S. FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of idiopathic hypersomnia in adults. Xywav is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as EDS, sleep inertia (severe grogginess or confusion when waking up), long sleep duration and cognitive impairment. Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults..

Xywav也是第一个也是唯一一个美国公司。S、 FDA批准成人特发性嗜睡的治疗选择。美国食品和药物管理局（FDA）承认Xywav对成人特发性嗜睡症的治疗具有七年的孤儿药专有权。Xywav是FDA批准的唯一针对特发性嗜睡多种症状进行研究的治疗方法，例如EDS，睡眠惯性（醒来时严重昏昏欲睡或困惑），睡眠时间长和认知障碍。Xywav可以作为两次或每夜一次的方案用于治疗成人特发性嗜睡。。

The exact mechanism of action of Xywav in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of Xywav are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.1 The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine.

Xywav治疗成人特发性嗜睡和发作性睡病中的猝倒和EDS的确切作用机制尚不清楚。据推测，Xywav的治疗效果是通过睡眠期间去甲肾上腺素能和多巴胺能神经元以及丘脑皮层神经元的GABAB作用介导的。S、缉毒署（DEA）已将Xywav指定为附表III药物。

The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.1,2 Because of the risks of central nervous system (CNS) depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS..

DEA将附表III药物、物质或化学品定义为具有中度至低身体和心理依赖可能性的药物。1,2由于中枢神经系统（CNS）抑郁以及滥用和误用的风险，Xywav只能通过风险评估和缓解策略（REMS）下的限制性计划（称为Xywav和XYREM REMS）获得。。

Important Safety Information for Xywav

Xywav的重要安全信息

WARNING: Taking XYWAV with other central nervous system (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.

警告：与其他中枢神经系统（CNS）抑制剂一起服用XYWAV，例如用于使您或您的孩子入睡的药物，包括阿片类镇痛药，苯二氮卓类药物，镇静抗抑郁药，抗精神病药，镇静抗癫痫药，全身麻醉药，肌肉松弛剂，酒精或街头药物，可能会导致严重的医疗问题，包括呼吸困难（呼吸抑制），低血压（低血压），警觉性变化（嗜睡），晕厥和死亡。

The active ingredient of XYWAV is a form of gamma hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death.

XYWAV的活性成分是γ-羟基丁酸（GHB）的一种形式。单独或与其他药物一起滥用或滥用非法GHB会导致警觉性（或意识）发生变化，从而导致严重的副作用。这些影响包括癫痫发作，呼吸困难（呼吸抑制），警觉性变化（嗜睡），昏迷和死亡。

Call your doctor right away if you or your child has any of these serious side effects. .

如果您或您的孩子有任何这些严重的副作用，请立即致电您的医生。

Because of these risks, you have to go through the XYWAV and XYREM REMS to have your or your child's prescription for XYWAV filled.

由于这些风险，您必须通过XYWAV和XYREM REMS才能填写您或您孩子的XYWAV处方。

Do not take XYWAV if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drinks alcohol, or has a rare problem called succinic semialdehyde dehydrogenase deficiency.

如果您服用或您的孩子服用其他睡眠药物或镇静剂（导致嗜睡的药物），饮酒或患有罕见的琥珀酸半醛脱氢酶缺乏症，请不要服用XYWAV。

Keep XYWAV in a safe place to prevent abuse and misuse. Selling or giving away XYWAV may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

将XYWAV保存在安全的地方，以防止滥用和误用。出售或赠送XYWAV可能会伤害他人，并且是违法的。告诉你的医生你是否曾经滥用或依赖酒精、处方药或街头毒品。

Anyone who takes XYWAV should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYWAV. Those activities should not be done until you know how XYWAV affects you or your child.

服用XYWAV的人在服用XYWAV后至少6小时内不应做任何需要完全清醒或危险的事情，包括开车、使用重型机械或驾驶飞机。在您了解XYWAV对您或您的孩子的影响之前，不应进行这些活动。

XYWAV can cause serious side effects, including the following:

XYWAV可能会引起严重的副作用，包括：

Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use XYWAV.

呼吸问题，包括呼吸缓慢、呼吸困难和/或睡眠时短时间不呼吸（睡眠呼吸暂停）。已经有呼吸或肺部问题的人在使用XYWAV时更有可能出现呼吸问题。

Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, or difficulty concentrating.

心理健康问题，包括困惑，看到或听到不真实的东西（幻觉），异常或令人不安的想法（异常思维），感到焦虑或不安，抑郁，自杀或试图自杀的想法，疲劳加剧，内疚或毫无价值的感觉，或难以集中注意力。

Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves. Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite..

如果你或你的孩子患有抑郁症或试图伤害自己，请告诉你的医生。如果您或您的孩子有心理健康问题或体重或食欲改变的症状，请立即致电您的医生。。

Sleepwalking. XYWAV can cause sleepwalking, which can cause injuries. Call your doctor if this occurs.

梦游。XYWAV会导致梦游，从而导致受伤。如果发生这种情况，请致电您的医生。

The most common side effects of XYWAV in adults include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, excessive sweating (hyperhidrosis), vomiting, diarrhea, dry mouth, parasomnia (a sleep disorder that can include abnormal dreams, abnormal rapid eye movement (REM) sleep, sleep paralysis, sleep talking, sleep terror, sleep-related eating disorder, sleep walking, and other abnormal sleep-related events), somnolence, fatigue, and tremor..

XYWAV在成人中最常见的副作用包括恶心、头痛、头晕、焦虑、失眠、食欲下降、出汗过多（多汗症）、呕吐、腹泻、口干、失眠（一种睡眠障碍，可能包括异常梦、异常快速眼动（REM）睡眠、睡眠麻痹、睡眠谈话、睡眠恐怖、睡眠相关进食障碍、梦游和其他异常睡眠相关事件）、嗜睡、疲劳和震颤。。

The most common side effects of XYREM (which also contains oxybate like XYWAV) in children include nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking.

XYREM（也含有类似羟丁酸酯的XYWAV）在儿童中最常见的副作用包括恶心，尿床，呕吐，头痛，体重减轻，食欲下降，头晕和梦游。

XYWAV can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of XYWAV.

如果不按照指示服用，XYWAV会导致身体依赖和对药物的渴望。这些并不是XYWAV所有可能的副作用。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

鼓励您向FDA报告处方药的负面副作用。访问www.fda.gov/medwatch，或致电1-800-fda-1088。

Please see full Prescribing Information, including Boxed Warning, here: https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf

请在此处查看完整的处方信息，包括盒装警告：https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf

About Xyrem® (sodium oxybate)Xyrem oral solution, CIII, is a product approved by the U.S. Food and Drug Administration (FDA) for both cataplexy and excessive daytime sleepiness in narcolepsy in adult and pediatric patients ages 7 and older.3 Xyrem may only be dispensed to patients enrolled in the XYWAV and XYREM REMS.

关于Xyrem®（羟丁酸钠）Xyrem口服液CIII是美国食品和药物管理局（FDA）批准用于7岁及以上成人和儿科患者发作性睡病的猝倒和白天过度嗜睡的产品。3 Xyrem只能分配给参加XYWAV和Xyrem REMS的患者。

Xyrem was first approved in the U.S. in 2002, based on clinical trial data in adults..

根据成人临床试验数据，Xyrem于2002年在美国首次获得批准。。

Important Safety Information for XyremWARNING: Taking XYREM with other CNS depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), dizziness (syncope), and death..

XYREM的重要安全信息警告：与其他中枢神经系统抑制剂一起服用XYREM，例如用于使您或您的孩子入睡的药物，包括阿片类镇痛药，苯二氮卓类药物，镇静抗抑郁药，抗精神病药，镇静抗癫痫药，全身麻醉药，肌肉松弛剂，酒精或街头药物，可能会导致严重的医疗问题，包括呼吸困难（呼吸抑制），低血压（低血压），警觉性变化（嗜睡），头晕（晕厥）和死亡。。

XYREM is a form of gamma hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death..

XYREM是γ-羟基丁酸（GHB）的一种形式。单独或与其他药物一起滥用或滥用非法GHB会导致警觉性（或意识）发生变化，从而导致严重的副作用。这些影响包括癫痫发作、呼吸困难（呼吸抑制）、警觉性改变（嗜睡）、昏迷和死亡。。

Because of these risks, you have to go through the XYWAV and XYREM REMS to have your or your child's prescription for XYREM filled.

由于这些风险，您必须通过XYWAV和XYREM REMS才能填写您或您孩子的XYREM处方。

Do not take XYREM if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol, or have a rare problem called succinic semialdehyde dehydrogenase deficiency.

如果您或您的孩子服用其他睡眠药物或镇静剂（导致嗜睡的药物），饮酒或患有罕见的琥珀酸半醛脱氢酶缺乏症，请不要服用XYREM。

Keep XYREM in a safe place to prevent abuse and misuse. Selling or giving away XYREM may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

将XYREM放在安全的地方，以防止滥用和误用。出售或赠送XYREM可能会伤害他人，并且是违法的。告诉你的医生你是否曾经滥用或依赖酒精、处方药或街头毒品。

Anyone who takes XYREM should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYREM. Those activities should not be done until you know how XYREM affects you or your child.

服用XYREM的人在服用XYREM后至少6小时内不应做任何需要完全清醒或危险的事情，包括开车、使用重型机械或驾驶飞机。在你知道XYREM如何影响你或你的孩子之前，不应该进行这些活动。

XYREM can cause serious side effects, including the following:

XYREM可能会导致严重的副作用，包括：

呼吸问题，包括呼吸缓慢、呼吸困难和/或睡眠时短时间不呼吸（睡眠呼吸暂停）。已经有呼吸或肺部问题的人在使用XYREM时更有可能出现呼吸问题。

Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, or thoughts of killing yourself or trying to kill yourself. Tell your doctor if you or your child have or had depression or have tried to harm yourself.

心理健康问题，包括困惑，看到或听到不真实的东西（幻觉），异常或令人不安的想法（异常思维），感到焦虑或不安，抑郁，或自杀或试图自杀的想法。如果你或你的孩子患有抑郁症或试图伤害自己，请告诉你的医生。

Call your doctor right away if you have or your child has symptoms of mental health problems..

如果您或您的孩子有心理健康问题的症状，请立即致电您的医生。。

Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child starts sleepwalking. Your doctor should check you or your child.

梦游。梦游会造成伤害。如果您或您的孩子开始梦游，请致电您的医生。你的医生应该检查你或你的孩子。

Tell your doctor if you are or your child is on a salt-restricted diet or if you have or your child has high blood pressure, heart failure, or kidney problems. XYREM contains a lot of sodium (salt) and may not be right for you or your child.

告诉你的医生你或你的孩子是否在限盐饮食，或者你或你的孩子是否患有高血压、心力衰竭或肾脏问题。XYREM含有大量钠（盐），可能不适合您或您的孩子。

The most common side effects of XYREM include nausea, sleepiness, dizziness, vomiting, bedwetting, and tremor (in adults). In pediatric patients, headache, decreased appetite, and weight decrease were also common. Your side effects may increase when you take higher doses of XYREM. XYREM can cause physical dependence and craving for the medicine when it is not taken as directed.

XYREM最常见的副作用包括恶心，嗜睡，头晕，呕吐，尿床和震颤（成人）。在儿科患者中，头痛，食欲下降和体重减轻也很常见。服用高剂量的XYREM可能会增加副作用。如果不按照指示服用，XYREM会导致身体依赖和对药物的渴望。

These are not all the possible side effects of XYREM..

这些并不是XYREM可能产生的所有副作用。。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

鼓励您向FDA报告处方药的负面副作用。访问www.fda.gov/medwatch，或致电1-800-fda-1088。

Please find full prescribing information here: http://pp.jazzpharma.com/pi/xyrem.en.USPI.pdf

请在此处找到完整的处方信息：http://pp.jazzpharma.com/pi/xyrem.en.USPI.pdf

About Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options.

关于Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc（纳斯达克：Jazz）是一家全球生物制药公司，其宗旨是创新，改变患者及其家人的生活。我们致力于为患有严重疾病的人开发改变生命的药物-通常治疗选择有限或没有。

We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.

我们有多种上市药物，包括治疗睡眠障碍和癫痫的领先疗法，以及不断增长的癌症治疗组合。我们以患者为中心，以科学为驱动的方法，在我们强大的肿瘤学和神经科学创新疗法管道中推动了开创性的研究和开发进展。

Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information..

Jazz总部位于爱尔兰都柏林，在多个国家拥有研发实验室、制造设施和员工，致力于为全球患者提供服务。有关更多信息，请访问www.jazzpharmaticals.com。。

Media Contact:Kristin BhavnaniHead of Global Strategic Brand EngagementJazz Pharmaceuticals plcCorporateAffairsMediaInfo@jazzpharma.comIreland +353 1 637 2141U.S. +1 215 867 4948

媒体联系人：Kristin Bhavnani全球战略品牌参与主管Jazz PharmaceuticalsplcCorporateAffairsMediaInfo@jazzpharma.comIreland+353 1 637 2141U。S、 +1 215 867 4948

Investors:Andrea N. Flynn, Ph.D.Vice President, Head, Investor RelationsJazz Pharmaceuticals plcInvestorInfo@jazzpharma.com Ireland +353 1 634 3211U.S. +1 650 496 2717

投资者：Andrea N.Flynn博士，副总裁，投资者关系主管Azz PharmaceuticalsplcInvestorInfo@jazzpharma.com爱尔兰+353 1634 3211美元。S、 +16504962717

References:

参考文献：

National Institute of Neurological Disorders and Stroke. Narcolepsy. https://www.ninds.nih.gov/health-information/disorders/narcolepsy?search-term=narcolepsy#toc-what-is-narcolepsy-. Accessed April 2024.

国家神经疾病和中风研究所。嗜睡症。https://www.ninds.nih.gov/health-information/disorders/narcolepsy?search-术语=发作性睡病#toc什么是发作性睡病-。2024年4月访问。

Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007;369(9560):499-511.

Dauvilliers Y，Arnulf I，Mignot E.发作性睡病伴瘫痪。柳叶刀。2007年；369（9560）：499-511。

Colten HR, Altevogt BM, Institute of Medicine (US) Committee on Sleep Medicine and Research, eds. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington (DC): National Academies Press (US); 2006.

Colten HR，Altevogt BM，医学研究所（美国）睡眠医学和研究委员会，编辑。睡眠障碍和睡眠剥夺：未得到满足的公共卫生问题。华盛顿（DC）：国家科学院出版社（美国）；2006

Peacock J, Benca RM. Narcolepsy: clinical features, co-morbidities & treatment. Indian Journal of Medical Research. 2010;131(2):338-349.

Peacock J，Benca RM。发作性睡病：临床特征，合并症和治疗。印度医学研究杂志。2010年；131（2）：338-349。

National Health Service. Narcolepsy – Overview. 2019. https://www.nhs.uk/conditions/narcolepsy/. Accessed April 2024.

国家卫生局。发作性睡病–概述。2019https://www.nhs.uk/conditions/narcolepsy/.2024年4月访问。

Ben-Joseph RH, Saad R, Black J, et al. Cardiovascular burden of narcolepsy disease (CV-BOND): a real-world evidence study. Presented at: 2022 AAN Annual Meeting; April 2-7; Seattle, Washington. Poster 1203.

Ben Joseph RH，Saad R，Black J等。发作性睡病的心血管负担（CV-BOND）：一项现实世界的证据研究。出席：2022年AAN年会；4月2-7日；华盛顿州西雅图。海报1203。

Black J, Reaven NL, Funk SE, et al. Medical comorbidity in narcolepsy: findings from the Burden of Narcolepsy Disease (BOND) study. Sleep Med. 2017;33:13-18.

Black J，Reaven NL，Funk SE等。发作性睡病的医学合并症：来自发作性睡病负担（BOND）研究的发现。睡眠医学2017；33:13-18。

Ohayon MM, Black J, Lai C, et al. Increased mortality in narcolepsy. Sleep. 2014;37(3):439-444.

Ohayon MM，Black J，Lai C等。嗜睡症死亡率增加。睡觉。2014年；37（3）：439-444。

Ohayon MM. Narcolepsy is complicated by high medical and psychiatric comorbidities: a comparison with the general population. Sleep Med. 2013;14(6):488-492.

Ohayon MM。发作性睡病伴有高度的医学和精神病合并症：与普通人群的比较。睡眠医学2013；14（6）：488-492。

Billiard M, Sonka K. Idiopathic hypersomnia. Sleep Med Rev. 2016;29:23-33.

台球M，Sonka K.特发性嗜睡。睡眠医学版2016；29:23-33。

Trotti LM. Idiopathic hypersomnia. Sleep Med Clin. 2017;12(3):331-344.

特罗蒂LM。特发性嗜睡。睡眠医学临床。2017年；12（3）：331-344。

American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.

美国睡眠医学学会。国际睡眠障碍分类。第三版（ICSD-3）。2014

Khan Z, Trotti LM. Central disorders of hypersomnolence: focus on the narcolepsies and idiopathic hypersomnia. Chest. 2015 Jul;148(1):262-273.

Khan Z，Trotti LM。嗜睡的中枢性疾病：关注发作性睡病和特发性嗜睡。胸部。2015年7月；148（1）：262-273。

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition (DSM-5). 2020.

美国精神病学协会。精神障碍诊断和统计手册。第五版（DSM-5）。2020

Jazz Pharmaceuticals, Inc, Data on file. JZP258-2020-047-29 Oct 2020.

Jazz Pharmaceuticals，Inc，存档数据。JZP258-2020-047-29 2020年10月。

Evangelista E, Lopez R, Dauvilliers Y. Update on treatment for idiopathic hypersomnia. Expert Opin Investig Drugs. 2018;27(2):187-192.

Evangelista E，Lopez R，Dauvilliers Y.特发性嗜睡治疗的最新进展。专家Opin Investig Drugs。2018年；27（2）：187-192。

Ozaki A, Inoue Y, Hayashida K, et al. Quality of life in patients with narcolepsy with cataplexy, narcolepsy without cataplexy, and idiopathic hypersomnia without long sleep time: comparison between patients on psychostimulants, drug-naïve patients and the general Japanese population. Sleep Med. 2012;13(2):200-206..

Ozaki A，Inoue Y，Hayashida K等。发作性睡病伴猝倒、无猝倒和特发性嗜睡且睡眠时间不长患者的生活质量：精神兴奋剂患者、未服用药物的患者与普通日本人群的比较。睡眠医学2012；13（2）：200-206。。

Jazz Pharmaceuticals, Inc, Data on file.

Jazz Pharmaceuticals，Inc，存档数据。

Anderson KN, Pilsworth S, Sharples LD, et al. Idiopathic hypersomnia: a study of 77 cases. Sleep. 2007;30(10):1274-1281.

Anderson KN，Pilsworth S，Sharples LD等。特发性嗜睡：77例研究。睡觉。2007年；30（10）：1274-1281。

Masri TJ, Gonzales CG, Kushida CA. Idiopathic hypersomnia. Sleep Med Clin. 2012;7(2):283-289.

Masri TJ，Gonzales CG，Kushida CA。特发性嗜睡。睡眠医学临床。2012年；7（2）：283-289。

Trotti LM, Arnulf I. Idiopathic hypersomnia and other hypersomnia syndromes. Neurotherapeutics. 2021;18(1):20-31.

Trotti LM，Arnulf I.特发性嗜睡和其他嗜睡综合征。神经治疗学。2021年；18（1）：20-31。

Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution. Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2021.

Xywav（钙、镁、钾和羟丁酸钠）口服溶液。处方信息。加利福尼亚州帕洛阿尔托：爵士制药公司，2021年。

United States Drug Enforcement Agency. Drug Scheduling. https://www.dea.gov/drug-scheduling. Accessed April 2024.