METHOD OF ADMINISTERING OXYBATE
Provided herein are methods of administering different GHB forms on different days for the treatment of narcolepsy, IH, EDS and other conditions.
1 . A method for transitioning a gamma hydroxy butyrate (GHB) dose regimen of a patient, the method comprising:
(1) administering GHB, a prodrug or a pharmaceutically acceptable salt thereof to a patient in need thereof in a first administration period, wherein the GHB is administered as a divided, twice daily (DTD) dose of about 4.5 g to about 9 g per night;
(2) administering GHB in a transition period, wherein the GHB is administered as a once daily (OD) dose;
(3) administering GHB in a maintenance period, wherein the GHB is administered as an OD dose that is higher than the dose administered during the transition period.
2 . The method of claim 1 , wherein the transition period dose is about 50% to about 76%, about 58% to about 73%, or 66% to about 70% of the first administration period dose.
3 . The method of claim 1 , wherein the transition period dose is about 0.5 g to about 2.0 g more than about half of the first administration period dose.
4 . The method of claim 1 , wherein the maintenance period dose is about 70% to about 97%, about 75% to about 88%, about 75% to about 95%, or about 77% to about 90% of the first administration period dose.
5 . The method of claim 1 , wherein the maintenance period dose is about 1.0 g to about 2.0 g or about 1.25 g to about 1.75 g less than the first administration period dose.
6 . The method of claim 1 , wherein the maintenance period dose is about 1.5 g less than the first administration period dose.
7 . The method of claim 1 , wherein the transition period dose is about 58% to about 73% of the first administration period dose and the dose for the maintenance period is about 75% to about 95% of the first administration period dose.
8 . The method of claim 1 , wherein the transition period dose is about 66% to about 70% of the first administration period dose and the dose for the maintenance period is about 77% to about 90% of the first administration period dose.
9 . The method of claim 1 , wherein the two doses during the first administration period are about equal.
10 . The method of claim 1 , wherein the transition period is 3 to 10 days, 4 to 9 days, 5 to 8 days, 6 to 8 days, or about 7 days.
11 . The method of claim 1 , wherein the GHB is administered at night.
12 . The method of claim 1 , wherein the GHB, a prodrug, or a pharmaceutically acceptable salt thereof, is a formulation comprising at least three cations selected from the group consisting of sodium, potassium, calcium and magnesium.
13 . The method of claim 1 , wherein the GHB, a prodrug, or a pharmaceutically acceptable salt thereof, is a formulation comprising the cations sodium, potassium, calcium and magnesium.
14 . The method of claim 1 wherein the GHB comprises about 5 mol % to about 40 mol % Na.GHB; about 10 mol % to about 40 mol % K.GHB; 5 mol % to about 30 mol % Mg.(GHB) 2 ; and 20 mol % to about 80 mol %. Ca.(GHB) 2 .
15 . The method of claim 14 , wherein the GHB comprises about 8 mol % Na.GHB; about 23 mol % K.GHB; 21 mol % Mg.(GHB) 2 ; and 48 mol % Ca.(GHB) 2 .
16 . The method of claim 1 , wherein the first administration period dose is about 6 g/day, the transition period dose is about 4 g/day and the maintenance period dose is about 4.5 g/day.
17 . The method of claim 1 , wherein the first administration period dose is about 7.5 g/day, the transition period dose is about 5.25 g/day and the maintenance period dose is about 6 g/day.
18 . The method of claim 1 , wherein the first administration period dose is about 9 g/day, the transition period dose is about 6 g/day and the maintenance period dose is about 7.5 g/day.
19 . A method for transitioning a gamma hydroxy butyrate (GHB) dose regimen of a patient, the method comprising:
(1) administering GHB, a prodrug or a pharmaceutically acceptable salt thereof to a patient in need thereof in a first administration period, wherein the GHB is administered as a divided, twice daily (DTD) dose of about 4.5 g to about 9 g per night;
(2) administering GHB in a maintenance period, wherein the GHB is administered as a dose that is higher than half the dose administered during first administration period.
20 . The method of claim 19 , wherein the first administration period dose is less than about 6.0 g per night.