The Xywav Drug and Dealing with Daytime Sleepiness
The Xywav Drug and Dealing with Daytime Sleepiness
August 26, 2021 by eMedEvents

The Xywav Drug and Dealing with Daytime Sleepiness

On July 21, 2021, the Food and Drug Administration of the United States approved the drug Xywav (calcium, magnesium, potassium, and sodium oxybate) to treat daytime sleepiness called idiopathic insomnia. The drug was granted "orphan drug" status and is approved to treat the rare condition affecting less than 200,000 people in the United States. The Dublin-based Jazz Pharmaceuticals got the approval for manufacturing and marketing the drug in the United States. 

 

While feeling tired throughout the day is common among people, some individuals have excessive daytime sleepiness and face significant challenges in school, work, and social relationships. Excessive daytime sleepiness is known as hypersomnia, and idiopathic hypersomnia is one form with no known cause.

 

The Director of medical toxicology at Rutgers New Jersey Medical School, Dr. Lewis S. Nelson, says about 40,000 people are diagnosed with idiopathic insomnia in the United States. Of every 5 Americans, 1 sees a doctor with a complaint of daytime sleepiness.

 

What is Idiopathic Insomnia?

Idiopathic hypersomnia is a chronic sleep disorder that causes extreme sleepiness during the day despite having a good or prolonged night's sleep. You may wake up more tired than when you went to bed, and there is often difficulty waking up after you have been asleep, whether at night or for a nap.

 

Symptoms

Excessive daytime sleepiness even after more than 10-11 hours per night is the main symptom of idiopathic hypersomnia. The other symptoms include:

  • Daytime naps that do not relieve drowsiness
  • ''Sleep drunkenness''
  • Increased need for sleep during the day -- even while at work, or during a meal or conversation
  • Increased sleep time -- up to 14 to 18 hours a day
  • Anxiety
  • Feeling irritated
  • Loss of appetite
  • Low energy
  • Restlessness
  • Slow thinking or speech
  • Trouble remembering

 

What is Xywav Drug?

The Xymav drug comprises active drug components of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. Xywav is associated with a group of medications known as the central nervous system (CNS) depressants and is accepted to treat the narcolepsy symptoms like cataplexy and excessive daytime sleepiness (EDS). 

According to the Food and Drug Administration, the approval was granted based on a clinical trial of 154 patients of age group 19-75 years, and the most common side effects of the drug were nausea (21.4%), headache (16.2%), dizziness (11.7%), anxiety (10.4%) and vomiting (10.4%). Moreover, the drug has a boxed warning for CNS depression, abuse, and misuse that may cause side effects like seizures, trouble breathing, changes in alertness, coma, and death.

 

Dosage

Initially, the doctor will recommend a low dosage which will be adjusted later to an amount suitable to you. The dosage will depend on several factors, which include:

  • the severity of the condition 
  • your age (and, in children only, bodyweight)
  • your body's response to Xywav drug
  • other medical conditions you may have
  • other medications you're taking

 

Dr. Eric Bastings, deputy director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, sees idiopathic hypersomnia as a chronic condition and terms the Xywav's approval instrumental in treating and managing the debilitating disorder effectively. While the CEO of Hypersomnia Foundation, Diane Powell, says that the condition has a significant impact on the social, educational, and occupational functioning of the patients and sees the FDA's approval as a breakthrough for the idiopathic hypersomnia community.  

 

How to take Xywav Drug?

Take Xywav drug as per the instructions of your healthcare provider. The drug comes as a solution, and you can take it after diluting the solution with water. Make sure you take the medication in two separate doses, one when you go to sleep and the next after 2.5 to 4 hours of the first dose.

 

Side Effects

While taking the drug, you may have some mild or severe side effects. Talk to your healthcare provider or a pharmacist about the possible side effects and get tips to deal with them. Following are some of the side effects that may occur while taking the Xywav:

  • headache
  • nausea, vomiting, or diarrhea
  • increased sweating
  • decreased appetite
  • dizziness
  • Allergic Reaction
  • Parasomnia
  • Breathing problems 

 

To know more about hypersomnia, idiopathic hypersomnia, and the drug Xywav, sign up for the below eMedEvents conferences, webcasts, and podcasts:

 

1.  Central Disorders of Hypersomnia Self-Assessment Exam

Organizer: American Academy of Sleep Medicine

Start Date: Sep 21, 2018

End Date: Sep 21, 2021

Credits: CME 2

              MOC 2

Ticket Cost: $100

 

2.  Are You Recognizing Excessive Daytime Sleepiness Associated with Obstructive Sleep?

Organizer: National Association for Continuing Education (NACE) 

Start Date: Jun 01, 2021

End Date: May 31, 2022

Credits: CME 1

Ticket Cost: Free

 

3.  Insomnia in Chronic Pain

Organizer: University of Arkansas for Medical Sciences (UAMS) 

Start Date: Mar 12, 2020

End Date: Mar 12, 2023

Credits: CME 1

Ticket Cost: Free

 

References:

  1. https://www.sleepreviewmag.com/sleep-disorders/hypersomnias/narcolepsy/narcolepsy-ih-prevalence/
  2. https://www.nytimes.com/2021/08/12/health/GHB-hypersomnia-sleep-FDA.html
  3. https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products
  4. https://www.usnews.com/news/health-news/articles/2021-08-13/date-rape-drug-gets-fda-approval-to-treat-rare-sleep-disorder
  5. https://www.medscape.com/viewarticle/956533
  6. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-jazz-pharmas-drug-excessive-daytime-sleepiness-2021-08-12/
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