Claims for Patent: 12,582,622

Summary for Patent: 12,582,622

Title:	Sodium oxybate to treat idiopathic hypersomnia
Abstract:	The present disclosure relates to methods of treating idiopathic hypersomnia with oxybate, preferably sodium oxybate.
Inventor(s):	Franck Skobieranda, Dan Chen, Amanda Leigh STERKEL
Assignee:	Jazz Pharmaceuticals Ireland Ltd
Application Number:	US18/248,499
Patent Claims:	1. A method of treating idiopathic hypersomnia in a patient in need thereof, the method comprising: administering a therapeutically effective amount of sodium oxybate to the patient. 2. A method of treating idiopathic hypersomnia in a patient in need thereof, the method comprising: administering a therapeutically effective amount of sodium oxybate to the patient, wherein the sodium oxybate is administered as a liquid and the concentration of sodium oxybate in the liquid is about 500 mg/mL. 3. The method of claim 1, wherein the sodium oxybate is administered as a liquid, and the concentration of the sodium oxybate in the liquid is from 350 mg/ml-650 mg/ml. 4. The method of claim 1, wherein the method comprises: (a) administering an initial daily dose of the sodium oxybate to the patient and (b) titrating the dose to provide the therapeutically effective amount of the sodium oxybate. 5. The method of claim 4, wherein the initial daily dose is from about 3 g to about 4.5 g of the sodium oxybate. 6. The method of claim 4, wherein the titration step (b) comprises administering ascending doses of the sodium oxybate. 7. The method of claim 1, wherein about 4.5 g to 9.0 g of the sodium oxybate is administered per day. 8. The method of claim 1, wherein the sodium oxybate is administered twice per day or once a day. 9. The method of claim 1, wherein about 4.5 g, about 6 g, about 7.5 g, or about 9 g of the sodium oxybate is administered per day. 10. The method of claim 1, wherein about 3 g, about 3.75 g, or about 4.5 g of the sodium oxybate is administered per day. 11. The method of claim 1, wherein the sodium oxybate is administered at bedtime. 12. The method of claim 2, wherein the method comprises: (a) administering an initial daily dose of the sodium oxybate to the patient and (b) titrating the dose to provide a therapeutically effective amount of the sodium oxybate. 13. The method of claim 12, wherein the initial daily dose is from about 0.5 g to about 4.5 g of the sodium oxybate administered per day. 14. The method of claim 12, wherein the titration step (b) comprises administering ascending doses of the sodium oxybate. 15. The method of claim 14, wherein dose is increased by about 0.5 g to 1.5 g per week. 16. The method of 12, wherein the titration step (b) comprises administering descending doses of the sodium oxybate. 17. The method of claim 16, wherein dose is decreased by about 0.5 g to 9.0 g per week. 18. The method of claim 12, wherein the titration step (b) comprises switching a patient from a once a day dose to a twice a day dose of the sodium oxybate. 19. The method of claim 12, wherein the titration step (b) comprises switching a patient from a twice a day dose to a three times a day, or a once a day dose of the sodium oxybate. 20. The method of claim 2, wherein about 0.25 g-10.0 g of the sodium oxybate is administered per day. 21. The method of claim 4, wherein the initial daily dose is 4.5 g of sodium oxybate, and the dose is titrated to 6 g to 9 g of sodium oxybate per night. 22. The method of claim 4, wherein the sodium oxybate is in a mixed salt oxybate. 23. The method of claim 22, wherein the mixed salt oxybate comprises sodium oxybate, calcium oxybate, potassium oxybate, and magnesium oxybate. 24. The method of claim 23, wherein the mixed salt oxybate comprises about 8% sodium oxybate, about 23% potassium oxybate, about 21% magnesium oxybate, and about 48% calcium oxybate (% mol. eq.). 25. The method of claim 22, wherein the initial daily dose is 3.0 g of mixed salt oxybate, and the dose is titrated to 4.5 g to 9 g of mixed salt oxybate per night. 26. The method of claim 21, wherein the sodium oxybate is provided in a solid formulation. 27. The method of claim 21, wherein the sodium oxybate is present in a sustained release oxybate composition. 28. The method of claim 21, wherein the sodium oxybate is administered once daily. 29. The method of claim 22, wherein the mixed oxybate is administered once daily or twice daily.