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WHY XYWAV FOR IH

Study results with XYWAV IH

STUDY RESULTS WITH XYWAV: Daytime sleepiness
What changes in excessive daytime sleepiness were seen in people during the XYWAV clinical trial?
  • Excessive daytime sleepiness (EDS) is measured by a screener called the Epworth Sleepiness Scale (ESS)
  • The ESS measured EDS on a scale from 0 to 24
During the first part of the trial:
During the period of the trial that measured how well XYWAV worked:
Results shown here used average scores, which were then rounded up or down. That’s why the difference between scores may not always appear to add up.

Not sure of your ESS score?

Get an ESS screener here to help find out your level of daytime sleepiness.

Source: Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep. 1991;14(6):540-545.

The Epworth Sleepiness Scale is intended to measure for EDS, a symptom of IH. It is not intended to make an IH diagnosis.

What changes in overall IH symptoms were seen in people during the XYWAV clinical trial?
  • How well XYWAV helps treat symptoms of IH overall was measured by a screener called the Patient Global Impression of Change (PGIc)
  • The PGIc asked participants to rate how their IH felt using a 7-point scale ranging from “very much improved” to “very much worse”
Patient Global Impression of Change (PGIc)

Did you know?

  • In clinical trials, a PGIc is often used to measure the effect of a treatment on the person’s condition
  • In this study, the PGIc was used to collect information on how patients felt their IH changed overall
What changes in IH symptoms were seen in people during the XYWAV clinical trial?
  • Severity of idiopathic hypersomnia symptoms is measured by a screener called the Idiopathic Hypersomnia Severity Scale (IHSS)
  • The IHSS is a unique screener—it is the only one validated to measure IH symptoms
  • The IHSS asks participants to answer 14 questions related to the frequency and intensity of a range of symptoms—including long sleep time, cognitive impairment, and sleep inertia
  • The IHSS measures frequency and severity of IH symptoms on a scale of 0 to 50
During the first part of the trial:
During the period of the trial that measured how well XYWAV worked:
Results shown here used average scores, which were then rounded up or down. That’s why the difference between scores may not always appear to add up.

You may not know your IHSS score. Here’s how you can find out what it is.

The IHSS includes 14 questions that help you rate the severity and frequency of your IH symptoms.

Get an IHSS screener here to help measure your IH symptom severity.

Source: Dauvilliers Y, Evangelista E, Barateau L, et al. Measurement of symptoms in idiopathic hypersomnia: the Idiopathic Hypersomnia Severity Scale. Neurology. 2019;92(15):e1754-e1762.

The Idiopathic Hypersomnia Severity Scale is intended to measure the frequency and severity of IH symptoms. It is not intended to make an IH diagnosis.

XYWAV® (calcium, magnesium, potassium, and sodium oxybates) oral solution, 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate) is a prescription medicine used to treat:

 

  • the following symptoms in people 7 years of age or older with narcolepsy:
    • sudden onset of weak or paralyzed muscles (cataplexy)
    • excessive daytime sleepiness (EDS)
  • idiopathic hypersomnia (IH) in adults.

Important Safety Information

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.

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

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.

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.

 

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.

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.

XYWAV can cause serious side effects, including the following:

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

 

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, sleepwalking, and other abnormal sleep-related events), somnolence, fatigue, and tremor.

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.

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.

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.

 

Please see full Prescribing Information, including BOXED Warning, and Medication Guide.

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