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Xywav vs Xyrem
Introduction
For patients with narcolepsy, a neurological disorder that affects the control of sleep and wakefulness, certain drugs that regulate the sleep-wake cycle can help in managing excessive daytime sleepiness and cataplexy. Xywav and Xyrem are two such drugs that are prescribed for narcolepsy. They each impact the GABA neurotransmitter system in the brain, but both have wakefulness-promoting effects in patients with narcolepsy. Xyrem is sodium oxybate, a strong central nervous system depressant, which enhances slow-wave sleep and reduces the number of awakenings during the night. Xywav, on the other hand, is a lower-sodium alternative to Xyrem, containing calcium, magnesium, potassium, and sodium oxybates. It offers the same benefits as Xyrem with lower sodium intake, which is beneficial for patients with heart conditions or high blood pressure.
Xywav vs Xyrem Side By Side
| Attribute | Xywav | Xyrem |
|---|---|---|
| Brand Name | Xywav | Xyrem |
| Contraindications | Cannot be taken with alcohol or sedative hypnotics. Not to be used by patients with a history of drug abuse or addiction. | Cannot be taken with alcohol or sedative hypnotics. Not to be used by patients with a history of drug abuse or addiction. |
| Cost | $12,000 to $15,000 for a one-month supply | $12,000 to $15,000 for a one-month supply |
| Generic Name | Calcium, magnesium, potassium, and sodium oxybates | Sodium oxybate |
| Most Serious Side Effect | Increased thoughts about suicide or self-harm, severe allergic reactions, cardiovascular symptoms like rapid heartbeat and shortness of breath | Severe allergic reactions, increased risk of suicidal thoughts and behaviors, seizures |
| Severe Drug Interactions | Alcohol, sedative hypnotics | Alcohol, sedative hypnotics |
| Typical Dose | 6–9 g/night, divided into two doses | 4.5 grams/night, divided into two doses, up to a maximum of 9 grams per night |
What is Xywav?
Xywav (calcium, magnesium, potassium, and sodium oxybates) is a newer version of the drug Xyrem (sodium oxybate), both of which are central nervous system depressants prescribed primarily for the treatment of narcolepsy symptoms such as excessive daytime sleepiness and cataplexy. Xywav was approved by the FDA in 2020, marking a significant advancement in the treatment of narcolepsy. It works by reducing the reabsorption of certain neurotransmitters in the brain, effectively keeping them available for longer periods. Xywav, like Xyrem, is intended for the treatment of narcolepsy but is considered a major development because it contains significantly less sodium than Xyrem, making it a safer option for patients who need to monitor or reduce their sodium intake. The reduced sodium content results in Xywav having fewer side effects related to high sodium intake compared to Xyrem.
What conditions is Xywav approved to treat?
Xywav is approved for the treatment of various sleep disorders including:
- Narcolepsy in adult and pediatric patients 7 years of age and older, specifically cataplexy (sudden loss of muscle tone) or excessive daytime sleepiness (EDS)
- Idiopathic hypersomnia in adults.
Just like Xyrem, it helps reduce the number of cataplexy attacks and EDS episodes but with significantly less sodium content making it a better option for long-term use especially for those who are managing their sodium intake.
How does Xywav help with these illnesses?
Xywav helps manage symptoms of narcolepsy, a neurological disorder that affects the control of sleep and wakefulness, by increasing the amount of hypocretin in the brain. Hypocretin is a neurotransmitter that plays a key role in arousal, wakefulness, and appetite. Xywav does this by mimicking the actions of a neurotransmitter called GABA, which is known to decrease hypocretin activity. In individuals with narcolepsy, there is a significant reduction in hypocretin, which leads to excessive daytime sleepiness and sudden loss of muscle control, known as cataplexy. By mimicking the action of GABA, Xywav can increase hypocretin activity, thus reducing the symptoms of narcolepsy and helping patients manage their condition. Notably, Xywav is a lower-sodium alternative to Xyrem, which is beneficial for patients who need or prefer to reduce their sodium intake.
What is Xyrem?
Xyrem is a brand name for sodium oxybate, which is a central nervous system depressant and acts by increasing levels of gamma-aminobutyric acid (GABA) in the brain. GABA reduces nerve cell activity, thereby promoting sleepiness and reducing muscle tone. Xyrem was first approved by the FDA in 2002 as a treatment for symptoms associated with narcolepsy such as excessive daytime sleepiness and cataplexy — sudden loss of muscle control. Unlike other treatments for narcolepsy that act on various neurotransmitters like norepinephrine or dopamine, Xyrem's mechanism focuses primarily on modulating GABA receptors to promote restful sleep - essential for managing symptoms of narcolepsy. Its side-effect profile differs from other medications due to its unique action; common side effects can include nausea, dizziness, vomiting but it does not typically cause weight gain or sexual dysfunction seen with some types of antidepressants or sedatives. It has been instrumental in treating patients who do not respond well to traditional stimulant-based therapies.
What conditions is Xyrem approved to treat?
Xyrem is a medication that has been approved by the FDA for use in treating two key symptoms of narcolepsy:
- Excessive daytime sleepiness (EDS)
- Cataplexy, which is a sudden and uncontrollable muscle weakness or paralysis that comes on during the day.
How does Xyrem help with these illnesses?
Xyrem, also known as sodium oxybate, is a medication that functions by influencing GABA and glycine neurotransmitters in the brain. It's primarily used to treat narcolepsy symptoms such as excessive daytime sleepiness and cataplexy - a sudden loss of muscle tone triggered by strong emotions. Xyrem strengthens the quality of nocturnal sleep which indirectly reduces daytime sleepiness and episodes of cataplexy. While it shares similarities with its counterpart Xywav, there are distinguishing factors too. Unlike Xywav which is essentially a lower-sodium version of Xyrem, regular use of Xyrem can lead to an increase in daily sodium intake due to its high salt content. This could pose health risks for patients with heart problems or hypertension thus requiring careful monitoring by healthcare providers during treatment.
How effective are both Xywav and Xyrem?
Both sodium oxybate (Xyrem) and calcium, magnesium, potassium, and sodium oxybates (Xywav) are effective treatments for narcolepsy. They were approved by the FDA in 2002 and 2020 respectively. Since they act on gamma-aminobutyric acid type B receptors to reduce cataplexy and excessive daytime sleepiness associated with narcolepsy, their prescription circumstances are quite similar.
The effectiveness of Xyrem was well-established through several double-blind clinical trials conducted since its approval; it successfully managed symptoms of narcolepsy while maintaining a satisfactory safety profile. Likewise, Xywav demonstrated similar efficacy in managing these symptoms during its clinical trial phase as per an evaluation done in 2020.
A review based on various studies suggests that Xyrem is highly effective from the first week of treatment with improved wakefulness during daytime and reduced sudden muscle weakness episodes or cataplexies. It's also reported that despite being a controlled substance due to potential abuse and misuse risks, it's one of the most prescribed medications for narcolepsy patients who experience cataplexy.
On the other hand, even though less research has been performed on Xywav due to its recent release compared to Xyrem's long history since approval by FDA in 2002 , early indications suggest it is equally efficacious while offering an advantage over Xyrem: lower sodium content which means fewer dietary restrictions for patients at risk from high blood pressure or heart disease. Nonetheless data confirming its long-term efficacy as standalone treatment still needs further confirmation through more extensive research.
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At what dose is Xywav typically prescribed?
Oral dosages of Xywav range from 6–9 g/night, divided into two doses. The initial total nightly dose is typically 4.5 g/night and may be increased by your doctor to the recommended maximum dosage of 9 g/night depending on your response and tolerance levels. For children and adolescents with narcolepsy, the starting dose is usually lower at around 0.25 g/kg per night, which can also be increased over time if there's no improvement in symptoms. In all cases, it's important not to exceed the maximum dosage recommended by your healthcare provider.
At what dose is Xyrem typically prescribed?
Xyrem treatment is generally initiated at a dosage of 4.5 grams/night, divided into two doses. The first dose is taken at bedtime and the second dose is taken 2.5 to 4 hours later. This can then be increased over weeks to a maximum dosage of up to 9 grams per night, depending on your response and tolerance to the drug. Each dose should not exceed 4.5 grams due to its potential side effects and risks associated with higher single doses. If there's no noticeable improvement in symptoms or if adverse reactions are severe, your physician may adjust this dosing regimen accordingly.
What are the most common side effects for Xywav?
Common side effects of both Xywav and Xyrem include:
- Nausea
- Dizziness/Lightheadedness
- Vomiting
- Bedwetting
- Sweating excessively
- Decreased appetite
- Headache
More serious side effects can include confusion, hallucinations, trouble breathing during sleep (sleep apnea), depression or worsening depression, suicidal thoughts or actions. It's important to note that while the two medications have similar purposes and often similar side effects, they may affect individuals differently due to differences in their formulation.
Are there any potential serious side effects for Xywav?
When comparing Xywav to Xyrem, similar side effects can occur. However, they are generally less severe with Xywav due to its lower sodium content. Side effects may include:
- Increased thoughts about suicide or self-harm
- Signs of allergic reaction: difficulty in breathing; swelling of your face, lips, tongue, or throat
- Changes in vision such as blurred vision or seeing halos around lights
- Cardiovascular symptoms like rapid heart beat and shortness of breath which could lead to fainting spells
- Symptoms indicating low levels of magnesium - irregular heartbeat, persistent fatigue, loss of appetite and muscle weakness
- Severe nervous system reactions such as stiff muscles accompanied by high fever and confusion leading to a fast heartbeat and the feeling that you might pass out.
It's important to note that very rarely some patients may experience symptoms indicative of serotonin syndrome such as agitation, hallucinations, fever sweating shivering fast heart rate muscle stiffness twitching loss of coordination nausea vomiting diarrhea when taking these medications. If any unusual side effects are experienced while on this medication it is crucial you contact your healthcare provider immediately.
What are the most common side effects for Xyrem?
Xyrem, a medication often prescribed for narcolepsy and excessive daytime sleepiness, can produce various side effects. These include:
- Nausea
- Dizziness or impaired balance
- Bedwetting or increased nighttime urination
- Morning grogginess
- Disorientation/confusion when waking up during the night Moreover, severe side effects such as shallow breathing during sleep, changes in mood or behavior (e.g., depression, hallucinations), and uncontrolled movements/twitching are also possible but less common. It is important to monitor these symptoms closely while taking Xyrem due to its risk of dependence and withdrawal issues.
Are there any potential serious side effects for Xyrem?
With Xyrem, while it is considered a safe and effective medication for most people with narcolepsy, there can be serious side effects in some cases. For example:
- Severe allergic reactions may occur, including hives or itching, difficulty breathing or swallowing, swelling in your face or throat.
- There could be an increased risk of suicidal thoughts and behaviors.
- Some patients have reported experiencing seizures (convulsions).
- There might be confusion and unusual changes in mood or behavior.
- Certain vision problems may occur such as blurred vision or seeing halos around lights.
- Rapid heartbeats are another potential adverse effect.
- In rare instances, you might experience symptoms similar to a manic episode: racing thoughts, hyperactivity, feeling extremely elated or irritable.
If you notice any of these significant side effects when using Xyrem please seek immediate medical attention.
Contraindications for Xywav and Xyrem?
Both Xywav and Xyrem, along with most other medications for narcolepsy, may worsen symptoms of sleep disorders in some individuals. If you notice your sleep disorder worsening, or an increase in depressive thoughts or suicidal ideation after starting these medications, please seek immediate medical attention.
Neither Xywav nor Xyrem can be taken if you are consuming alcohol or sedative hypnotics as it could lead to serious side effects like slowed breathing that can cause death. Always inform your doctor about all the medicines you take; stopping sedative hypnotics may require a gradual dose reduction under the supervision of your physician to prevent withdrawal symptoms.
It's important to know both drugs contain sodium oxybate which is a form of gamma hydroxybutyrate (GHB). GHB has been associated with illicit use due its euphoric effects at higher doses than those used therapeutically. Hence these drugs have stringent distribution controls and should never be shared even if someone else has similar symptoms.
How much do Xywav and Xyrem cost?
For the brand name versions of these drugs:
- The price of a one-month supply (180 mL) of Xyrem (500 mg/mL) can range from $12,000 to $15,000. This works out to about $400-$500/day depending on your dose.
- The cost for a similar quantity and concentration of Xywav averages around the same price as Xyrem.
Thus, both medications are similarly priced and the choice between them should be based primarily on their efficacy and tolerability in each individual patient rather than cost. Please note that costs can often be offset with insurance or manufacturer's coupon programs.
Currently, there are no generic versions available for either Xyrem or Xywav due to patent protections. Therefore, prices remain high across all dosage levels.
Popularity of Xywav and Xyrem
Xywav, also known as low-sodium oxybate, was introduced in the US market in 2020. It is a reformulation of Xyrem with significantly less sodium content. Xywav is prescribed for similar uses to its predecessor, namely symptoms related to narcolepsy such as excessive daytime sleepiness and cataplexy.
On the other hand, Xyrem (sodium oxybate) has been available since 2002 and has been used by tens of thousands of patients across America. Despite being an effective treatment for narcolepsy symptoms, there have been concerns about its high sodium content especially for patients who are on a sodium-restricted diet or have conditions that could be worsened by increased sodium intake.
In terms of prescriptions written specifically for these medications in recent years; due to the relative newness of Xywav and it being a specialized medication targeting specific patient population data may not yet fully reflect its reach or potential prevalence compared to established medicines like Xyrem. However with the introduction of this lower-sodium alternative we can expect many physicians will consider transitioning their patients from Xyrem to Xywav over time if appropriate considering individual patient's health circumstances.
Conclusion
Both Xywav (calcium, magnesium, potassium, and sodium oxybates) and Xyrem (sodium oxybate) are approved for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy. They share a common active ingredient: gamma-hydroxybutyrate (GHB), but differ significantly in their salt content - Xywav contains 92% less sodium than Xyrem.
While both medications can be effective treatments, choosing between them may require careful consideration by a physician due to this difference. For individuals who need to manage their sodium intake due to conditions such as heart disease or high blood pressure, the reduced-sodium version—Xywav—might be more appropriate.
Neither medication is available as a generic drug at present which could potentially represent a significant cost burden for patients paying out-of-pocket. Both Xywav and Xyrem have similar side effect profiles including nausea, bedwetting, anxiety among others; however these tend to decrease over time as the body adjusts.
Patients must closely monitor their symptoms while on either medication – if they notice worsening of depression or suicidal thoughts they should seek help immediately. Remember that abrupt discontinuation of these drugs can lead to withdrawal symptoms so it's important not to stop taking them without consulting your doctor first.
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Refrences
- Dauvilliers, Y., Bogan, R. K., Šonka, K., Partinen, M., Foldvary-Schaefer, N., & Thorpy, M. J. (2022, March). Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution: A Lower-Sodium Alternative for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy. Nature and Science of Sleep. Informa UK Limited.http://doi.org/10.2147/nss.s279345
- Junnarkar, G., Allphin, C., Profant, J., Steininger, T. L., Chen, C., Zomorodi, K., … Black, J. (2021, November 24). Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia. Expert Opinion on Drug Discovery. Informa UK Limited.http://doi.org/10.1080/17460441.2022.1999226
- Fuller, D. E., & Hornfeldt, C. S. (2003, September). From Club Drug to Orphan Drug: Sodium Oxybate (Xyrem) for the Treatment of Cataplexy. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. Wiley.http://doi.org/10.1592/phco.23.10.1205.32756
- Langford, J., & Gross, W. L. (2011, December 15). Psychosis in the Context of Sodium Oxybate Therapy. Journal of Clinical Sleep Medicine. American Academy of Sleep Medicine (AASM).http://doi.org/10.5664/jcsm.1478