The REVITALYZ study is testing a drug called FT218, which is a medicine taken once at night. It's a special form of a drug called sodium oxybate, made to release slowly in the body. This study will look at how safe and effective FT218 is for people with idiopathic hypersomnia, a condition that makes people feel very sleepy during the day for no known reason. The study lasts about 18 weeks for each person, including the time needed to see if they qualify.
- The study involves a double-blind approach, meaning neither the participants nor the researchers know who is getting the real drug or a fake one (placebo) until the end.
- Participants must have a stable routine with any other alertness drugs they are taking for at least two months before starting.
- Women and men in the study must use reliable birth control throughout the study and for a month after it ends.
People who are pregnant, breastfeeding, have untreated sleep apnea, certain mental health conditions, or a history of drug or alcohol problems can't join the study. Participants should be willing to follow study rules and attend all required visits.