People with certain types of long-term sleep disorders may use a medicine called sodium oxybate to help treat their condition. This medicine is taken at night and may help people with narcolepsy to feel less tired during the day. But every dose of sodium oxybate contains a large amount of sodium. And consuming too much sodium each day may be unsafe for some people.
Xywav is a medicine that is very similar to sodium oxybate, but it only contains about one-tenth (10%) as much sodium. It is also the only medicine approved for the treatment of both narcolepsy and another long-term sleep disorder called idiopathic hypersomnia.
How Does Xywav Work for Certain Chronic Sleep Disorders?
Although many people struggle with drowsiness and getting enough sleep at some point in their lives, some people have sleep disorders that cause chronic (long-term) issues with sleep. These types of sleep disorders are caused by changes in the way that the brain processes and responds to sleep.
One of these disorders, narcolepsy, causes extreme sleepiness during the day and a hard time focusing or staying awake. As a result, many people with narcolepsy fall asleep without warning, even if they are in the middle of an activity. Some people with narcolepsy also have something called cataplexy. During a cataplexy attack, a person suddenly loses muscle control. This can cause all types of issues, depending on which muscles are affected, from drooping eyelids, to a hard time speaking, to not being able to move at all. These attacks are most often caused by strong emotions and typically last for about 1-2 minutes.
Another disorder, called idiopathic hypersomnia (IH), also causes extreme sleepiness during the day. Unlike people with narcolepsy, people with IH do not have sleep attacks or cataplexy attacks. But they do feel very tired during the day, struggle to do normal activities, and often have a hard time waking up in the morning or after a nap.
Getting more sleep at night does not help with the symptoms of these conditions, so treatment may include different types of medicines. Some of these medicines work by stimulating the brain to make a person feel more awake during the day. Other medicines, such as certain antidepressants, may help people with cataplexy.
Sodium oxybate, also known as gamma-hydroxybutyrate (GHB), works very differently from these other medicines and is taken at night before falling asleep. It seems to change the way that a person’s brain responds to sleep so that they feel less tired during the day. But this medicine contains large amounts of sodium (up to 1,640 milligrams each day). Consuming large amounts of sodium can increase a person’s risk of high blood pressure and serious heart problems over time. Also, people with kidney problems, high blood pressure, or heart failure may not be able to take this much sodium each day.
Xywav works the same way as sodium oxybate, but it contains much less sodium (about 130 milligrams per day). This is because it contains other forms of oxybate, including calcium, magnesium, and potassium oxybates. It is sometimes called “low-sodium oxybate.”
How Do I Use It?
Xywav is a liquid that is taken by mouth at night. Some people will take the medicine only once at bedtime each night. Other people will take it at bedtime and again 2.5-4 hours later. Your health care provider will decide whether you should take it once or twice each night. When you first start taking Xywav, you will start with a low dose. Over the next few weeks, your health care provider may have you increase your dose. Most people reach their final dose within a month. Your final dose will depend on how well the medicine is working and whether you have any side effects.
To take Xywav, you will need to mix the liquid medicine with water. Your pharmacy will send you the supplies that you need to do this, including a syringe and extra containers. You will use the syringe to measure the right dose of the medicine. The medicine is then placed into one of the extra containers from the pharmacy and mixed with water. The container from the pharmacy will have a child-resistant cap so that you can securely close the container. Once you have mixed the medicine with water, the dose must be taken within 24 hours. Make sure to store it out of the reach of children and pets.
You should take Xywav at least 2 hours after eating. Take the medicine while you are in bed, then lie down right after taking it and stay in bed for the night. Most people who take Xywav fall asleep within 5-15 minutes after taking the dose.
If your health care provider tells you to take two doses each night, you may need to set an alarm to wake up for the second dose. You should follow all of the same steps for the second dose and stay in bed after taking it. If you accidentally miss your second dose, skip the dose completely. You should not take another dose until the next night.
How Was It Studied for Treating Narcolepsy and Idiopathic Hypersomnia?
Two studies were done to see if Xywav was safe and effective for adults with narcolepsy or idiopathic hypersomnia. Both of these studies included people who were at least 18 years old, with an average age of 37-40 years. Most of the people in these studies (61%-68%) were female. Most people were White (84-88%), about 6% were Black, and less than 1% were Asian. Many of the other people in the studies did not provide their race.
Narcolepsy study: Everyone in this study had narcolepsy with cataplexy attacks. About 37% of them were using sodium oxybate before the study started. Almost half (45%) of people in the study had never taken any medicines to treat their narcolepsy and cataplexy.
- This study measured efficacy by counting the number of cataplexy attacks.It also measured symptoms of sleepiness on a scale by asking people to rate how likely they are to fall asleep in different situations. Scores can range from 0 to 24, with higher scores meaning a person is more likely to fall asleep in many situations.
IH study: Everyone in this study had IH. Hardly anyone (4%) in this study was using sodium oxybate before the study started. Almost half (43%) of the people in the study had never taken any medicines to treat their IH.
- This study measured efficacy by asking people to rate their symptoms on two scales. One was the IH Severity Scale, which asks people to answer questions about their symptoms and how serious they are. Scores can range from 0 to 50, with a higher score meaning a person has more symptoms. People with IH usually have a score between 26 and 50. The other scale was the same sleepiness scale used in the narcolepsy study.
When these studies started, everyone began taking Xywav. People who were already taking sodium oxybate before the study stopped this medicine and switched to Xywav. People who had never taken sodium oxybate started with a low dose of Xywav and increased their dose over the next few weeks.
Everyone kept taking Xywav for 14 weeks. During this time, they all knew that they were taking the medicine. After 14 weeks, the people in the study were split into two groups. One group kept taking Xywav and the other group started taking a placebo (a dummy medicine that has no effect). No one knew which group they were in and whether they were taking the drug or the placebo.
What Were the Benefits?
Symptoms were measured for 2 weeks when everyone knew they were taking Xywav and then again during the 2 weeks when some people were taking the placebo.
Number of cataplexy attacks. In the 2 weeks after some people started taking the placebo, those taking it had about 11 more cataplexy attacks, on average, than they had while they were still taking Xywav. The people who kept using Xywav did not have any change in the number of cataplexy attacks, which means that they had fewer cataplexy attacks than people taking the placebo.
IH severity score. Before the study started, people with IH had an average score of 31 (most people with IH have a score between 26 and 50). When taking Xywav, the average score dropped to 15.5.
- In the 2 weeks after some people started taking the placebo, those taking it had their IH score increase by about 13, to an average score of 28.5. The people who kept using Xywav had their IH scores stay almost the same, which means they had fewer symptoms than the people taking the placebo.
Sleepiness score. In the 2 weeks after some people started taking the placebo, those taking it had higher sleepiness scores than they had while taking Xywav. The people who kept using Xywav had little or no change in their sleepiness scores, which means they reported less sleepiness than the people taking the placebo.
Has It Been Studied in Children?
Xywav is approved for people with narcolepsy who are 7 years or older. This approval was based on a clinical study of another medicine, sodium oxybate. Since Xywav and sodium oxybate work in a similar way and have similar side effects, another study in children was not required.
The study of sodium oxybate in children with narcolepsy included people who were 7-17 years old, with an average age of 12 years. It found that the children who took sodium oxybate had fewer cataplexy attacks and reported less sleepiness than the children who took a placebo.
How Quickly Will Xywav Work for Narcolepsy and Idiopathic Hypersomnia?
If Xywav is working for you, you should notice a change in your symptoms within a few days or weeks. If you have either narcolepsy or IH, you should feel less tired and it should become easier to stay awake during the day. If you have cataplexy, you should have fewer attacks.
Do not increase your dose without talking to your health care provider first. Taking too much Xywav can cause serious health issues. It is important to follow the instructions from your health care provider or pharmacist and only take the dose that is prescribed. If you are concerned that Xywav is not working, your health care provider can review your options with you.
How Can I Prevent or Manage Side Effects?
Xywav may cause behavior and mood changes in some people, such as becoming confused, cranky, aggressive, anxious, or disconnected from reality. Some people have also become depressed and have had suicidal thoughts. Following a daily schedule that includes exercise and a well-balanced diet can help with this. It may also help to write down how you are feeling and keep track of your moods and mental state.
Some people who use Xywav may have strange behaviors while they sleep, which are called parasomnias. Examples of these behaviors include unusual movements, bedwetting, sleepwalking, sleep talking, and night terrors. Ask the people close to you to let you know if they see any strange behavior while you are sleeping. If you know this is happening, you can talk to your health care provider about how to manage or prevent it.
When people first start taking Xywav, it may affect alertness and coordination. It is important not to drive, operate heavy machinery, or do any other activities that require alertness and coordination until you understand how Xywav affects you. Some signs that you are not safe to drive or perform these activities include being very dizzy, drowsy, unusually clumsy, or having trouble thinking.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Xywav, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
Are There Any Interactions With Other Medicines?
It is important for your health care provider to be aware of every medicine you are taking before you start using Xywav. It is especially important to let your doctor know if you are using any drugs that can cause drowsiness. Drugs that cause drowsiness may be used for many purposes, such as pain relief, muscle relaxation, and treating anxiety, seizures, and mental health problems.
Let your doctor know if you are using a drug called divalproex (Depakote). This medicine, which is used for seizures, can increase the blood levels of Xywav and increase the risk of serious side effects.
Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them to find the best treatment plan for you.
Is There Anything Else I Should Avoid While Using Xywav?
It is very important not to drink any alcohol while you are using Xywav. Using alcohol along with Xywav can increase your risk of having serious breathing problems. It may even cause you to stop breathing completely. If you drink alcohol on a regular basis and are not sure if you will be able to stop, speak with your health care provider about your options.
Many recreational drugs and other drugs that are used illegally may increase the risk of serious breathing problems from Xywav. These drugs are known as central nervous system (CNS) depressants. People sometimes use them because they cause drowsiness, relaxation, and lower a person’s inhibitions. It is unsafe to use these drugs while you are using Xywav. Talk with your health care provider about any of the drugs that you use.
What Are Other Unique Considerations to Be Aware Of?
Xywav is a schedule III medicine, which means it has a high risk of abuse and misuse. Your health care provider will monitor you while you’re on this medicine. You should always keep Xywav in a safe, locked place and should not share it with other people.
It is important not to throw any unused Xywav directly into the trash, since other people may be able to access it from there. If you need to dispose of any unused or expired medicine, empty the bottle down the sink drain. You can then place the empty bottle in the trash.
Are There Any Special Steps Required to Get Xywav?
If Xywav is misused, it can cause serious health issues and breathing problems. To reduce the risk of this happening, the medicine is only available through a restricted program, called the XYWAV and XYREM REMS program. You and your health care provider must both enroll in this program in order for you to receive this medicine.
As part of the restricted program, Xywav is only available from a specific certified pharmacy. Your health care provider will send your prescription to this pharmacy, which will ship the medicine directly to you.
Is There a Coupon Card Available?
There is a savings coupon available from the drugmaker that may allow you to pay as little as $5 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out more at https://www.xywav.com/jazzcares-for-xywav.
