IH is a rare central sleep disorder. Idiopathic means the cause is unknown. Central means it is related to how the brain works.
Some key symptoms of IH are feeling very sleepy during the day; experiencing sleep inertia (sleep drunkenness); and long, unrefreshing sleep. People living with IH still experience these symptoms despite sleeping a normal (or more than normal) amount each night.
XYWAV is the first and only FDA-approved treatment for idiopathic hypersomnia (IH). It is indicated for adults living with IH.
XYWAV is thought to work during sleep to help with the symptoms of idiopathic hypersomnia during the day. The exact way XYWAV works for the treatment of idiopathic hypersomnia is unknown.
The efficacy of XYWAV was studied in 115 people aged 19-75 with IH. The XYWAV IH clinical trial was a double-blind, randomized withdrawal trial. That means all people in the clinical trial started treatment with XYWAV. They all adjusted XYWAV to a stable dose (the dose that worked best for them). Then they were randomly assigned to continue treatment with XYWAV or switched to placebo for 2 weeks. Neither the clinical investigators nor the people in the trial knew who got XYWAV or who got placebo.
The most common side effects in adult patients treated with XYWAV in the idiopathic hypersomnia clinical trial included 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), sleepiness (somnolence), fatigue, and tremor. In patients who remained on treatment, side effects tended to occur early and diminish over time.
These are not all the possible side effects of XYWAV. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. 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.
After starting XYWAV, it may take some time for you and your doctor to determine the right dose, and to see symptoms improve. Your doctor will decide on a starting dose. If needed, he or she may adjust your dose or dosing routine.
XYWAV oral solution contains oxybate, a CNS depressant. XYWAV contains a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. A 9 gram/night dose contains 687 mg of calcium, 182 mg of magnesium, 642 mg of potassium, and 131 mg of sodium. XYWAV also contains an artificial sweetener called sucralose. XYWAV does not contain any ingredient made from a gluten-containing grain (wheat, barley, or rye).
If your doctor prescribes you nightly XYWAV, he or she will give you detailed instructions on how to take your prescribed dose(s). You will also receive additional materials to ensure that you understand how to prepare and take your nightly XYWAV dose(s).
It's easy to understand why you might worry about taking your second dose. You may want to set an alarm clock to help you wake up for your second dose of XYWAV. If you miss your second dose, skip that dose. Do not take XYWAV again until the next night. Never take two doses of XYWAV at one time.
Jazz Pharmaceuticals is committed to making sure that people who are prescribed XYWAV can get it affordably.
Jazz Pharmaceuticals, the leader in sleep medicine, is committed to helping you get therapy support and assistance throughout your treatment journey based on your personal needs every step of the way.
- Nurse and pharmacy support—Your JazzCares® Nurse Case Manager will be with you from the very beginning in your treatment journey, and a pharmacist is available 24/7 to answer questions about your prescription
- Access and affordability—The Certified Pharmacy will assist you with navigating the insurance process and understanding your insurance coverage to help get your treatment started
- Personalized resources—At different points along the way, you will receive relevant tools and resources to help as you start and continue your therapy, including:
- myWAV,the 24/7 digital tool for personalized support and motivation
- A Starter Kit to help you get started on your path to your first shipment of XYWAV
- A Welcome Kit with everything you need to manage your XYWAV treatment
- Prescription refill reminders
- Information and support resources for caregivers and loved ones
Because of the risk of CNS depression, abuse, and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS. You must be enrolled in this program to receive XYWAV.
In addition, the Certified Pharmacy is the only pharmacy in the United States that is permitted to fill your XYWAV prescription and send it directly to you.