20 abstracts presented across World Sleep and Psych Congresses showcase Jazz's leadership in sleep medicine
Novel results from the Phase 4 DUET trial underscore the significance of appropriate treatment options in adults with narcolepsy or idiopathic hypersomnia
For U.S. media and investors only
JazzPharmaceuticalsplc(Nasdaq:JAZZ) todayannounced new real-world evidence and Phase 4data reinforcing the value of Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution treatment outcomes in adults with narcolepsy or idiopathic hypersomnia (IH) were presented at World Sleep 2025, held in Singapore from September 5-10, 2025, as well as the 38th annual Psych Congress, held in San Diego from September 17-21, 2025. Notable Phase 4 data included new results from the DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, showing treatment effects of low-sodium Xywav on daytime and nighttime symptoms of narcolepsy or IH. The DUET trial is a Phase 4, prospective, single-arm, open-label study to assess the effect of Xywav treatment on excessive daytime sleepiness, polysomnography parameters, and functional outcomes in adults with narcolepsy or IH.
“These new DUET data presented by Jazz continue to show the importance of measuring and understanding the impact of treatment in both daytime and nighttime symptoms, as well as other functional outcomes in people living with narcolepsy or idiopathic hypersomnia,” said Logan Schneider, MD, adjunct clinical associate professor of sleep medicine, Stanford Sleep Center and Consultant Neurologist, Standford/VA Alzheimer's Center. “These results further reflect the positive implications that an appropriate treatment can have on patients' sleep outcomes, holistic health and their daily functioning.”
“We are leveraging both the power of Phase 4 clinical trials and real-world evidence to provide clinically meaningful, high-quality research for the global sleep community, which informs the health complexities of people living with narcolepsy and idiopathic hypersomnia,” said Kelvin Tan, MB BCh, MRCPCH, chief medical affairs officer of Jazz Pharmaceuticals. “These robust data continue to expand our understanding of sleep disorders and the challenges patients living with these conditions face while further reinforcing the value of low-sodium Xywav treatment.”
Presentation highlights include:
— Xywav DUET Sleep Actigraphy Results (World Sleep Poster #97): Novel analysis of DUET data examining the impact of Xywav treatment on actigraphy measures found participants with narcolepsy experienced fewer awakenings and decreased wake after sleep onset, suggesting improved sleep measures. Similarly, participants with IH treated with Xywav experienced fewer awakenings, suggesting improved sleep measures, as well as decreased nocturnal sleep time.
— Xywav DUET Sleep Inertia and Components of Daytime Sleepiness Results (World Sleep Poster #92): Analysis of DUET data evaluating Psychomotor Vigilance Test (PVT) lapses and Karolinska Sleepiness Scale (KSS) ratings among participants with IH receiving optimized Xywav treatment, demonstrated reduced sleep inertia magnitude by subjective and objective measures, subjective reduction in sleepiness upon waking and objective improvement in impaired alertness.
— Real-World Risk of Sodium-Associated Negative Clinical Outcomes Results (World Sleep Poster #101 and #186): Real-world analysis assessing the risk of sodium-associated negative clinical outcomes (NCOs) showed individuals with narcolepsy or IH have an elevated risk of development or progression of cardiovascular, cardiometabolic and renal NCOs relative to those without these conditions. These results emphasized the need to reduce sodium intake to mitigate the risk of NCOs among those living with these conditions.
— Xywav DUET >9 Gram Cohort (Psych Congress Poster #125): Complete cohort (n=48) analysis of top-line efficacy and safety data from DUET trial participants with narcolepsy taking 9-12 grams of Xywav nightly experienced additional symptom benefits, with reductions in Epworth Sleepiness Scale, Narcolepsy Severity Scale scores and cataplexy attacks, as compared to taking 9 grams per night at baseline. The Xywav label recommends a nightly dose of 6-9 grams per night for adults with narcolepsy. Overall, treatment-emergent adverse events were consistent with the known safety profile of Xywav at dosages less than 9 grams per night.
The abstracts presented at World Sleep 2025 are available online at ws2025.abstractserver.com/program.
The Psych Congress presentations are available on-demand through the conference mobile application. Abstracts and posters will also be published on HMP Global's Psychiatry & Behavioral Health Learning Network30-60 days after the congress ends.
About Narcolepsy Narcolepsy is a chronic, debilitating neurologic sleep disorder characterized by the inability to maintain continuous sleep at night and sustained wakefulness throughout the day. This leads to symptoms that can include fragmented or disrupted nighttime sleep, excessive daytime sleepiness, and cataplexy.1 Patients with EDS due to narcolepsy experience sleep attacks and, despite fighting the urge to sleep, may unintentionally fall asleep for short periods.2,3These sleep attacks may happen at inappropriate or potentially dangerous times such as during driving, cycling, eating, or mid-conversation.4
There is no cure for narcolepsy; the symptoms are lifelong and have a substantial negative impact on a person's ability to function psychologically, socially and professionally.5Patients with narcolepsy are at increased risk forhypertension, cardiometabolic morbidity,stroke, myocardial infarction, heart failure, cardiac arrest, and death.6,7,8,9 As narcolepsy is a chronic condition that requires lifelong treatment, early access to an effective treatment can help reduce the impact of narcolepsy symptoms on a person's physical and mental health, and long-term impacts of the treatment on cardiovascular health should be considered.5
About Idiopathic Hypersomnia Idiopathic hypersomnia is an often debilitating, neurologic sleep disorder that goes beyond chronic excessive daytime sleepiness.10,11,12,13Idiopathic hypersomnia is a 24-hour sleep disorder, and symptoms may include non-restorative sleep with or without long sleep time (main, nighttime, sleep episode of more than 9 hours, or a sleep duration of 11 hours or longer over a 24-hour period); severe sleep inertia (prolonged difficulty waking, with frequent reentries into sleep, confusion, and irritability); long and unrefreshing naps; cognitive impairment and brain fog, or the inability to focus for long periods of time.10,11,12,13,14Although there are some overlapping clinical features with narcolepsy, idiopathic hypersomnia is a condition with its own specific diagnostic criteria.13,15
Idiopathic hypersomnia is an often debilitating illness that can significantly affect social, educational, and occupational functioning.16,17In theU.S., approximately 37,000 adult patients have been diagnosed with idiopathic hypersomnia and are actively seeking healthcare.18This 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. It is estimated that far fewer patients are currently receiving pharmacological treatment for their idiopathic hypersomnia.18,19,20,21
About Xywav®(calcium, magnesium, potassium, and sodium oxybates) oral solution Xywavis the only low-sodium oxybate approved by theU.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 forXywavfor the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings forXywavfor 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. The decision of the OOPD is based on the FDA findings thatXywavprovides a greatly reduced chronic sodium burden compared toXyrem.Xywavhas 131 mg of sodium at the maximum recommended nightly dosewhereas other high sodium oxybates have 1640 mg at the equivalent dose.Xywavis comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night at the recommended dose range of 6 g to 9 g/night.Xywavis the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake.
Xywavis also the first and onlyU.S.FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity forXywavfor the treatment of idiopathic hypersomnia in adults.Xywavis 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.Xywavcan be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.
The exact mechanism of action ofXywavin the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects ofXywavare mediated through GABABactions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.22TheU.S.Drug Enforcement Agency(DEA) has designatedXywavas a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.22,23Because of the risks of central nervous system (CNS) depression and abuse and misuse,Xywavis available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.
Important Safety Information for Xywav
ContraindicationsXYWAViscontraindicated
— in combination with sedative hypnotics or alcohol and
— in patients withsuccinicsemialdehydedehydrogenasedeficiency.
Warnings and PrecautionsCentral Nervous System DepressionThe concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (e.g., post- or perioperative) is required, interruption of treatment with XYWAV should be considered.
Afterfirst initiating treatmentand until certain thatXYWAVdoes not affectthemadversely (e.g., impairjudgment, thinking,or motor skills), cautionpatients againsthazardousactivitiesrequiring completemental alertnessor motorcoordinationsuch as operatinghazardousmachinery, includingautomobilesor airplanes. Also caution patients against these hazardous activities for at least 6 hours after takingXYWAV. Patientsshould be queriedabout CNS depression-related eventsupon initiationof XYWAVtherapyandperiodicallythereafter.
Abuse and MisuseXYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known asgamma-hydroxybutyrate (GHB), a ScheduleI controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features ofGHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g., assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.
XYWAVandXYREMREMSBecause of the risks of central nervous system depression and abuse and misuse,XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS.
NotablerequirementsoftheXYWAVandXYREMREMSinclude thefollowing:
— Healthcare Providers who prescribeXYWAVarespecially certified
— XYWAVwillbedispensedonlybythecentralpharmacy thatisspeciallycertified
— XYWAVwill be dispensedand shippedonly to patientswho are enrolled in the XYWAV andXYREMREMSwithdocumentationofsafeuse
Furtherinformationis availableatwww.XYWAVXYREMREMS.comor1-866-997-3688.
Respiratory Depression and Sleep-Disordered BreathingXYWAV may impair respiratory drive, especially in patients with compromised respiratory function. Inoverdosesof oxybateandwith illicituse of GHB, life-threatening respiratory depressionhas beenreported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult andpediatricpatients. A significant increasein thenumberof central apneasand clinically significantoxygendesaturationmay occurin patients with obstructivesleep apneatreated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy.
Depression andSuicidalityIn Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depressionand depressed mood were reported in 3% and 4%, respectively,of patients treated with XYWAV. Two patients(1%)discontinuedXYWAV becauseof depression. In most cases, no change in XYWAV treatment was required.
In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment.
Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders. The emergenceofdepressionin patients treatedwith XYWAV requires careful and immediateevaluation. Monitor patients for the emergence of increaseddepressivesymptoms and/or suicidalitywhiletakingXYWAV.
Other Behavioral or Psychiatric Adverse ReactionsIn Study 1, confusion and anxiety occurred in 1% and 5% of patients with narcolepsy treated with XYWAV, respectively. One patient experienced visual hallucinations and confusion after ingesting approximately 9 grams of XYWAV.
In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively.One patient experienced visual hallucinations, which led to discontinuation of XYWAV.
Otherneuropsychiatricreactions reportedwith oxybate(sameactivemoiety as XYWAV)in adult or pediatric clinicaltrialsand in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV shouldbecarefully monitored.
ParasomniasParasomniascanoccurinpatientstakingXYWAV.
In Study 1 and Study 2,parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated withXYWAV, respectively.
Inaclinical trialofXYREM(sameactive moietyasXYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate(sameactivemoietyasXYWAV) andinpostmarketingexperiencewithsodiumoxybate.
Episodesofsleepwalkingshouldbefullyevaluatedandappropriateinterventionsconsidered.
Most Common Adverse ReactionsThemostcommon adversereactions (occurring in ≥5% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache,dizziness, anxiety, insomnia, decreased appetite,hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.
Inthepediatric clinicaltrialwithXYREM(sameactivemoietyasXYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (≥5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). The overall adverse reaction profile ofXYREM in the pediatricclinical trial was similar to that seen in the adult clinical trialprogram. The safety profile in pediatric patientswith XYWAV is expectedto be similarto thatof adultpatients treatedwith XYWAV and to that of pediatric patients treated with XYREM.
Additional Adverse ReactionsAdverse reactions that occurred in2-<5% of adult patients treated with XYWAV in the Open Label Titration and Stable Dose Periods of the randomized-withdrawal study in adult patients with narcolepsy with cataplexy (Study 1) were fatigue, dry mouth, depressed mood, enuresis, irritability, paresthesia, depression, tremor, somnolence, and muscle spasms. Adverse reactions occurring in 2-<5% of patients treated withXYWAV in the IH study include balance disorder, muscle spasms, fall, paresthesia,snoring, weight decreased, bruxism, confusional state, depressed mood, feeling drunk, and irritability.
Adverse reactions that occurred in≥2% of patients in clinical studies with oxybate (but not inStudy1)andwhichmayberelevant forXYWAV,werepain,feeling drunk,paininextremity,cataplexy, disturbanceinattention,sleepparalysis,anddisorientation.
Discontinuation: In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%). In Study 2, 17 of 154 (11%) patients across all study periods (excluding placebo during the DBRWP) (up to 42weeks) reported adverse reactions that led to withdrawal from the study (anxiety, nausea, insomnia, vomiting, fatigue, feeling abnormal, fall, decreasedappetite, dizziness, paresthesia, tremor, parasomnia, confusional state, hallucination visual, and irritability). The most common adverse reaction leading to discontinuation was anxiety (3.2%). In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment.
In the pediatric clinical trial with XYREM (same active moiety as XYWAV), 7 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache).
Drug InteractionsXYWAV is contraindicated in combination with alcohol or sedative hypnotics. Use of other CNS depressantsmaypotentiatetheCNS-depressanteffects ofXYWAV.
Concomitantuse of sodiumoxybate with divalproexsodiumresults in an increase in systemicexposure toGHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study. A similar increase in exposure is expected with concomitant use ofXYWAV and divalproexsodium; therefore, an initial dose reduction of XYWAV is recommended when used concomitantly withdivalproexsodium. Prescribersare advisedto monitorpatientresponse closely and adjust dose accordinglyifconcomitantuseofXYWAVanddivalproexsodiumiswarranted.
Pregnancy and LactationThere are no adequate data on the developmental risk associated with the use of XYWAV or sodiumoxybatein pregnant women. XYWAV should be used during pregnancyonly if the potential benefitjustifiesthepotentialrisktothefetus.GHB is excreted in human milk after oral administration of sodiumoxybate.There is insufficientinformationon the risk to a breastfed infant, and there is insufficientinformationon milkproductionin nursingmothers.Thedevelopmentalandhealthbenefits ofbreastfeeding should beconsidered along with the mother's clinical need for XYWAV and any potential adverse effects on the breastfed infantfrom XYWAVorfromtheunderlying maternalcondition.
Pediatric UseThe safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial for narcolepsy or IH. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and well-controlled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic dataof sodium oxybate from adult and pediatric patients, and pharmacokinetic dataof XYWAVfromhealthyadultvolunteers.
SafetyandeffectivenessofXYWAVinpediatricpatients belowtheageof7yearswith narcolepsy havenotbeenestablished.
Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established.
Geriatric UseIn general, dose selection for an elderly patient should be cautious, usually starting at the low end of thedosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and ofconcomitantdisease orotherdrugtherapy.
Hepatic ImpairmentThestartingdoseofXYWAVshouldbereducedinpatientswithliverimpairment.
Dosage Modification in Patients with Hepatic Impairment:The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses.
Dependence and ToleranceTherehavebeencasereportsofwithdrawal,rangingfrommildtosevere,followingdiscontinuationofillicit use of GHBat frequentrepeateddoses(18g to 250 g per day)in excessof the recommendeddosage range. Signs and symptomsof GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required.
In the clinical trial experiencewithXYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In theXYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses,one patientreported insomniafollowingabruptdiscontinuationofXYWAV. In the XYWAV clinical trial in adult idiopathic hypersomnia patients at recommended doses, six patients reported insomnia, two patients reported early insomnia, and one patient reported visual and auditory hallucinations following abrupt discontinuation of XYWAV.
Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have beensome case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen.
Please see full Prescribing Information, including BOXED Warning here:https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf
About Jazz PharmaceuticalsJazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases – often with limited or no therapeutic options. 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. Jazz is headquartered inDublin, Irelandwith research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Contacts:
Media:Kristin BhavnaniHead of Global Corporate CommunicationsJazz Pharmaceuticals plcCorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141U.S. +1 215 867 4948
Investors:Jack SpinksExecutive Director, Investor RelationsJazz Pharmaceuticals plcInvestorInfo@jazzpharma.comIreland +353 1 634 3211U.S. +1 650 496 2717
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— United States Drug Enforcement Agency. Drug Scheduling.https://www.dea.gov/drug-information/drug-scheduling. Accessed August 2025.
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