Xywav for Narcolepsy and Idiopathic Hypersomnia

(XYRISE Trial)

This trial tests the effectiveness and safety of different dosing regimens of Xywav, a medication for individuals with narcolepsy or idiopathic hypersomnia, which causes excessive daytime sleepiness. Participants will join one of four groups, receiving Xywav or a placebo either once or twice nightly. Eligible participants include those with narcolepsy or idiopathic hypersomnia who experience significant daytime sleepiness and may or may not currently use oxybate treatment. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment option.

The trial requires that you do not take any medications that are contraindicated with Xywav, have known interactions with it, or cause significant sedation. If you are on such medications, you may need to stop them before participating.

Previous studies have shown that Xywav is generally well-tolerated, with most people not experiencing severe side effects. The most common side effects include nausea, dizziness, and headaches, which are usually mild and similar to those of sodium oxybate, another treatment for sleep disorders.

The FDA has already approved Xywav for treating narcolepsy and idiopathic hypersomnia (IH) in adults, indicating its safety for these conditions. However, it is important to note that Xywav can cause serious effects, such as slowed breathing, if not taken as directed.

Researchers are excited about Xywav for treating narcolepsy and idiopathic hypersomnia because it offers a novel approach with its unique formulation. Unlike traditional treatments like modafinil or sodium oxybate, Xywav is a lower-sodium oxybate solution that reduces sodium intake, which is beneficial for patients concerned about heart health. Additionally, Xywav provides flexible dosing options, allowing for once-nightly or twice-nightly administration, which can be tailored to fit the patient's lifestyle and improve adherence to treatment. This flexibility and lower sodium content make Xywav a promising option in managing these sleep disorders.

Research has shown that Xywav effectively treats narcolepsy and idiopathic hypersomnia (IH). Studies have found that Xywav reduces excessive daytime sleepiness in individuals with these conditions. For those with narcolepsy, it also improves disrupted nighttime sleep. In people with IH, it helps manage symptoms such as difficulty thinking clearly and trouble waking up. This trial will evaluate both once-nightly and twice-nightly doses of Xywav, which demonstrated positive results in previous studies. Overall, Xywav serves as a valuable treatment option for these sleep disorders.¹²⁶⁷⁸