Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy

Abstract

Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient.

1 . A method of treating a condition responsive to sodium gamma-hydroxybutyrate, comprising administering to a patient afflicted with the condition an aqueous composition comprising about 350-750 mg/ml sodium gamma-hydroxybutyrate, wherein the administrating comprises the patient taking a first dosage of about 0.1 to about 10 grams of sodium gamma-hydroxybutyrate. 
     
     
         2 . The method of  claim 1 , wherein the first dose is about 2 to about 5 grams of sodium gamma-hydroxybutyrate. 
     
     
         3 . The method of  claim 1 , wherein the condition is selected from the group consisting of a sleep disorder, a drug consumption disorder, a reduced growth hormone level and an increased level of intracranial pressure. 
     
     
         4 . The method of  claim 3 , wherein the sleep disorder is apnea, sleep time disturbances, narcolepsy, catalepsy, sleep paralysis, hypnagogic hallucination, sleep arousal, daytime sleepiness, insomnia, or nocturnal myoclonus. 
     
     
         5 . The method of  claim 1 , wherein the condition is narcolepsy. 
     
     
         6 . The method of  claim 1 , wherein the condition is a catalepsy. 
     
     
         7 . The method of  claim 1 , wherein the condition is daytime sleepiness. 
     
     
         8 . The method of  claim 1 , wherein the administration is oral. 
     
     
         9 . The method of  claim 1 , wherein the first dose is administered within an hour prior to initial sleep onset. 
     
     
         10 . The method  claim 1  further comprising a second dose. 
     
     
         11 . The method of  claim 10 , wherein the second dose is administered within about 2 to about 5 hours following initial sleep onset. 
     
     
         12 . The method of  claim 10 , wherein the second dose comprises about 2 to about 5 grams of sodium gamma-hydroxybutyrate. 
     
     
         13 . The method of  claim 1 , wherein the aqueous composition comprises a solution or a dispersion of sodium gamma-hydroxybutyrate in water. 
     
     
         14 . A method of treating a condition responsive to sodium gamma-hydroxybutyrate, comprising administering to a patient afflicted with the condition a first dose of 0.1 to 10 grams of sodium gamma-hydroxybutyrate within an hour prior to initial sleep onset and a second dose of 0.1 to 10 grams within 2 to 5 hours following initial sleep onset. 
     
     
         15 . The method of  claim 14 , wherein the first dose is about 2 to about 5 grams of sodium gamma-hydroxybutyrate. 
     
     
         16 . The method of  claim 14 , wherein the second dose is about 2 to about 5 grams of sodium gamma-hydroxybutyrate. 
     
     
         17 . The method of  claim 14 , wherein the condition is selected from the group consisting of a sleep disorder, a drug consumption disorder, a reduced growth hormone level and an increased level of intracranial pressure. 
     
     
         18 . The method of  claim 17 , wherein the sleep disorder is apnea, sleep time disturbances, narcolepsy, catalepsy, sleep paralysis, hypnagogic hallucination, sleep arousal, daytime sleepiness, insomnia, or nocturnal myoclonus. 
     
     
         19 . The method of  claim 14 , wherein the condition is narcolepsy. 
     
     
         20 . The method of  claim 14 , wherein the condition is a catalepsy. 
     
     
         21 . The method of  claim 14 , wherein the condition is daytime sleepiness. 
     
     
         22 . The method of  claim 14 , wherein the administration is oral.