US 12,138,233 B2
Methods of treating idiopathic hypersomnia
Franck Skobieranda, Palo Alto, CA (US); Dan Chen, Los Altos, CA (US); Amanda Leigh Sterkel, Santa Clara, CA (US); Cuiping Chen, Palo Alto, CA (US); and Patricia Chandler, Palo Alto, CA (US)
Assigned to Jazz Pharmaceuticals Ireland Limited, Dublin (IE)
Filed by JAZZ PHARMACEUTICALS IRELAND LIMITED, Dublin (IE)
Filed on Feb. 22, 2021, as Appl. No. 17/180,991.
Claims priority of provisional application 63/142,738, filed on Jan. 28, 2021.
Claims priority of provisional application 63/088,902, filed on Oct. 7, 2020.
Claims priority of provisional application 63/069,811, filed on Aug. 25, 2020.
Claims priority of provisional application 62/993,381, filed on Mar. 23, 2020.
Claims priority of provisional application 62/979,667, filed on Feb. 21, 2020.
Prior Publication US 2022/0008367 A1, Jan. 13, 2022
Int. Cl. A61K 31/19 (2006.01); A61K 9/08 (2006.01); A61P 25/00 (2006.01)
CPC A61K 31/19 (2013.01) [A61K 9/08 (2013.01); A61P 25/00 (2018.01)] 23 Claims
 
1. A method of treating idiopathic hypersomnia in a patient in need thereof, the method comprising:
a twice daily dosing regimen, comprising (a) administering to an adult patient with idiopathic hypersomnia an initial daily dose of less than or equal to about 4.5 grams of a mixed salt oxybate divided equally or unequally into 2 doses; and (b) titrating the daily dose to provide a therapeutically effective amount of the mixed salt oxybate, wherein the maximum daily dose is about 9 grams divided equally or unequally into 2 doses; or
a once daily dosing regimen, comprising (a) administering to an adult patient with idiopathic hypersomnia an initial daily dose of less than or equal to about 3 grams of the mixed salt oxybate; and (b) titrating the daily dose to provide a therapeutically effective amount of the mixed salt oxybate, wherein the maximum daily dose is about 6 grams;
wherein the mixed salt oxybate comprises about 5%-40% sodium oxybate, about 10%-40% potassium oxybate, about 5%-30% magnesium oxybate, and about 20%-80% of calcium oxybate (% mol. eq.).