Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
Provided herein are methods of administering a once-nightly dosage of gamma-hydroxybutyrate after a high-fat meal.
1. A method of treating narcolepsy, cataplexy, or excessive daytime sleepiness in a human subject in need thereof, the method comprising orally administering to the subject a once-nightly dosage of a gamma-hydroxybutyrate formulation comprising an immediate release portion and a modified release portion, wherein oral administration immediately after a high-fat meal results in a mean reduction in C max of gamma-hydroxybutyrate by 33% and a T max of gamma-hydroxybutyrate that is approximately 1 h longer as compared to administering the once-nightly dosage in a fasted state.
2. The method of claim 1 , wherein mean C max in a fed state is 64.0 μg/mL.
3. The method of claim 1 , wherein fat comprises 50% of the total content of the high-fat meal.
4. The method of claim 1 , wherein the high-fat meal comprises 500-600 kcal derived from fat.
5. The method of claim 1 , wherein AUC inf is lower in a fed state as compared to a fasted state.
6. The method of claim 1 , further comprising advising the human subject that consumption of alcohol is contraindicated with the once nightly dosage and may result in a more rapid release of the gamma-hydroxybutyrate.
7. The method of claim 1 , wherein the modified release portion comprises microparticles comprising gamma-hydroxybutyrate.
8. The method of claim 1 , wherein the immediate release portion comprises microparticles comprising gamma-hydroxybutyrate.
9. A method of treating narcolepsy, cataplexy, or excessive daytime sleepiness in a human subject in need thereof, the method comprising orally administering a gamma-hydroxybutyrate formulation to the subject, wherein the administering occurs only once daily, and wherein oral administration of the formulation immediately after a high-fat meal results in a mean reduction in C max of gamma-hydroxybutyrate by 33% and an average Tmax increase of gamma-hydroxybutyrate from 0.5 hr to 1.5 hr as compared to administering the formulation in a fasted state.
10. The method of claim 9 , wherein mean C max of gamma-hydroxybutyrate in a fed state is 64.0 μg/mL.
11. The method of claim 9 , wherein fat comprises 50% of the total content of the high-fat meal.
12. The method of claim 9 , wherein the high-fat meal comprises 500-600 kcal derived from fat.
13. The method of claim 9 , wherein AUC inf is lower in a fed state as compared to a fasted state.
14. The method of claim 9 , further comprising advising the human subject that consumption of alcohol is contraindicated with the formulation and may result in a more rapid release of gamma-hydroxybutyrate.