sodium oxybate profile

crocacin C: structure in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Sodium Oxybate: The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ID Source	ID
PubMed CID	6476010
SCHEMBL ID	434332
MeSH ID	M0020115
PubMed CID	23663870
CHEMBL ID	1200682
SCHEMBL ID	61823
MeSH ID	M0020115

Synonym
(2e,4e,10e)(6s,7s,9s,8r)-7,9-dimethoxy-3,6,8-trimethyl-11-phenylundeca-2,4,10-trienamide
crocacin c
(2e,4e,6s,7s,8r,9s,10e)-7,9-dimethoxy-3,6,8-trimethyl-11-phenyl-undeca-2,4,10-trienamide
(2e,4e,6s,7s,8r,9s,10e)-7,9-dimethoxy-3,6,8-trimethyl-11-phenylundeca-2,4,10-trienamide
SCHEMBL434332
237425-38-6
(+)-crocacin c
DTXSID801037224
nsc-84223
unii-7g33012534
gamma hydroxybutyric acid preparations
butanoic acid, 4-hydroxy-, sodium salt (1:1)
jzp-6
7g33012534 ,
dea no. 2012
gamma-hydroxybutyrate sodium salt
natrium 4-hydroxybutyrat
nsc 84223
gamma-hydroxy sodium butyrate
einecs 207-953-3
sodium gamma-hydroxybutyrate
sodium-4-hydroxybutyrate
gamma-hydroxybutyrate sodium
4-hydroxybuttersaeure natriumsalz
gamma-hydroxybutyric acid, sodium salt
sodium oxybate [usan]
sodium oxybutyrate
anetamin
sodium gammahydroxybutyrate
sodium oxybate (usan)
D05866
xyrem (tn)
4-hydroxybutyric acid sodium salt
butanoic acid, 4-hydroxy-, monosodium salt
butanoic acid, 4-hydroxy-, sodium salt
sodium 4-hydroxybutyrate
sodium oxybate
butyric acid, 4-hydroxy-, monosodium salt
butyric acid, 4-hydroxy-, sodium salt
4 hydroxybutyrate sodium
oxybate, sodium
oxybutyrate, sodium
sodium gamma hydroxybutyrate
H-4040
HMS2091E15
sodium oxybat
catabate
lumryz
CHEMBL1200682
.gamma.-hydroxybutyrate sodium salt
sodium 4-hydroxybutanoate
cas-502-85-2
dtxcid6028866
dtxsid3048940 ,
tox21_112871
AKOS006221428
FT-0626615
.gamma.-hydroxybutyrate sodium salt [mi]
xywav component sodium oxybate
90318-49-3
sodium oxybate [orange book]
sodium salt of gamma-hydroxybutyric acid
sodium oxybate [mart.]
sodium oxybate [vandf]
sodium oxybate [hsdb]
sodium oxybate [ema epar]
sodium oxybate component of xywav
oxybate sodium [who-dd]
CCG-212465
SCHEMBL61823
CS-4796
XYGBKMMCQDZQOZ-UHFFFAOYSA-M
oxybate (sodium)
HY-B1187
acetamide,2,2-dichloro-n-[(1r,2r)-2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]-,rel-
ghb sodium salt (sodium gammahydroxybutyrate)
DB09072
Q7553347
\|a-hydroxybutyric acid sodium salt
sodium oxybate (mart.)
ghb.sodium salt
ghb.sodium salt, 1mg/ml in methanol

Excerpt	Reference	Relevance
"A simplified, safe and flexible technique of anesthesia, based on a limited number of relatively cheap drugs, and allowing ventilation with air, was applied to 60 patients undergoing operations of at least 60 minutes' duration."	( A simple, cheap, effective and safe procedure for general anesthesia. Lelkens, JP, 1976)	0.26
" After reports of toxic effects of gamma-hydroxybutyrate and its resultant regulation by the federal government, 1,4-butanediol and gamma-butyrolactone, another precursor of gamma-hydroxybutyrate and an industrial solvent, began to be marketed as dietary supplements."	( Adverse events, including death, associated with the use of 1,4-butanediol. Hall, BJ; McCutcheon, JR; Peacock, EA; Smith, SW; Spillane, J; Zvosec, DL, 2001)	0.31
"From June 1999 through December 1999, we identified cases of toxic effects of 1,4-butanediol involving patients who presented to our emergency departments with a clinical syndrome suggesting toxic effects of gamma-hydroxybutyrate and a history of ingesting 1,4-butanediol and patients discovered through public health officials and family members."	( Adverse events, including death, associated with the use of 1,4-butanediol. Hall, BJ; McCutcheon, JR; Peacock, EA; Smith, SW; Spillane, J; Zvosec, DL, 2001)	0.31
"We identified nine episodes of toxic effects in eight patients who had ingested 1,4-butanediol recreationally, to enhance bodybuilding, or to treat depression or insomnia."	( Adverse events, including death, associated with the use of 1,4-butanediol. Hall, BJ; McCutcheon, JR; Peacock, EA; Smith, SW; Spillane, J; Zvosec, DL, 2001)	0.31
" These include acute toxic effects, which may be fatal, and addiction and withdrawal."	( Adverse events, including death, associated with the use of 1,4-butanediol. Hall, BJ; McCutcheon, JR; Peacock, EA; Smith, SW; Spillane, J; Zvosec, DL, 2001)	0.31
" Pretreatment with 4-MP increased the Toxic Dose-50 (TD(50)) of 1,4-BD for the righting reflex from 585 mg/kg (95% CI, 484-707 mg/kg) in control mice to 5,550 mg/kg (95% CI, 5,353-5,756 mg/kg) in pretreated mice."	( Pretreatment of CD-1 mice with 4-methylpyrazole blocks toxicity from the gamma-hydroxybutyrate precursor, 1,4-butanediol. Desai, MC; Maher, TJ; Quang, LS; Shannon, MW; Woolf, AD, 2002)	0.31
"This article summarizes the short-term physiological toxicity and the adverse behavioral effects of four substances (GHB, ketamine, MDMA, and Rohypnol) that have been used at latenight dance clubs."	( Acute toxic effects of club drugs. Gable, RS, 2004)	0.32
" The authors hypothesized that in the setting of severe GHB intoxication, physostigmine would reverse sedation without producing adverse effects such as a decrease in heart rate, seizures, and fasciculations."	( Physostigmine does not effect arousal but produces toxicity in an animal model of severe gamma-hydroxybutyrate intoxication. Bania, TC; Chu, J, 2005)	0.33
" None demonstrated response and, further, there were associated adverse events, including atrial fibrillation (2), pulmonary infiltrates (1) and significant bradycardia (1), and hypotension (1)."	( Physostigmine for gamma-hydroxybutyrate coma: inefficacy, adverse events, and review. Litonjua, R; Smith, SW; Westfal, RE; Zvosec, DL, 2007)	0.34
" It is well tolerated with adverse event withdrawal rates of approximately 3-10% after acute and chronic administration."	( Sodium oxybate: efficacy, safety and tolerability in the treatment of narcolepsy with or without cataplexy. Owen, RT, 2008)	0.35
" The most common treatment related adverse events were headache and nausea."	( A safety trial of sodium oxybate in patients with obstructive sleep apnea: Acute effects on sleep-disordered breathing. Feldman, N; George, CF; Grzeschik, SM; Inhaber, N; Lai, C; Steininger, TL; Zheng, Y, 2010)	0.36
"We retrospectively reviewed postmarketing spontaneous adverse event (AE) reports from 15 countries for all cases containing reporting terminology related to abuse/misuse to determine its occurrence."	( Safety overview of postmarketing and clinical experience of sodium oxybate (Xyrem): abuse, misuse, dependence, and diversion. Benowitz, NL; Carter, LP; Swick, TJ; Thorpy, MJ; Wang, YG, 2009)	0.35
" Adverse events, most commonly headache, were noted in nine of 27 (33%) and six of 23 (26%) patients receiving SXB and PBO, respectively."	( A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome. Feldman, N; George, CF; Grzeschik, SM; Inhaber, N; Lai, C; Steininger, TL; Zheng, Y, 2011)	0.37
" Of 72 cases with antemortem adverse effects reported, medical assistance was delayed or absent in 66; of these, acute GHB ingestion was known in 51, including 40 left to "sleep off" adverse effects."	( Case series of 226 γ-hydroxybutyrate-associated deaths: lethal toxicity and trauma. Dyer, JE; Porrata, T; Smith, SW; Strobl, AQ; Zvosec, DL, 2011)	0.37
" Adverse events (AEs) were reported in 114 patients (56%), serious AEs in five (2%)."	( A 12-week open-label, multicenter study evaluating the safety and patient-reported efficacy of sodium oxybate in patients with narcolepsy and cataplexy. Black, J; Emsellem, H; Lai, C; Mamelak, M; Montplaisir, J; Swick, T, 2015)	0.42
"1 per cent did not adhere to recommended time schedule, with few associated treatment-emergent adverse events (TEAEs)."	( Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study. Bentz, JWG; Iranzo, Á; Mayer, G; Ortega-Albás, J; Pesch, H; Plazzi, G; Quinnell, T; Schlit, AF; Serralheiro, P; Wuiame, D, 2018)	0.48
" We describe female and male patients treated for acute recreational drug toxicity, and look for gender differences in clinical state, treatment, and toxic agents taken."	( Gender differences in acute recreational drug toxicity: a case series from Oslo, Norway. Brekke, M; Grimsrud, MM; Heyerdahl, F; Hovda, KE; Persett, PS; Syse, VL; Vallersnes, OM, 2019)	0.51
"The objective of this study was to determine if supportive care without endotracheal intubation in the emergency department (ED) was safe in the absence of complications in gamma-hydroxybutyrate (GHB)/gamma-butyrolactone (GBL) intoxicated patients with a decreased Glasgow Coma Scale (GCS) score."	( Safety of withholding intubation in gamma-hydroxybutyrate- and gamma-butyrolactone-intoxicated coma patients in the emergency department. Gresnigt, FMJ; van Helmond, LPFM, 2020)	0.56
" Primary endpoint was major adverse events, defined by: upper airway obstruction not resolved with mayo tube or nasopharyngeal airway, hypoxia not resolved with 15 l of oxygen delivered via non-rebreathing mask, bradypnea not resolved after stimulation, intubation, bradycardia not resolved after intravenous atropine bolus, hypotension for which inotropes were started."	( Safety of withholding intubation in gamma-hydroxybutyrate- and gamma-butyrolactone-intoxicated coma patients in the emergency department. Gresnigt, FMJ; van Helmond, LPFM, 2020)	0.56
" Major adverse events were reported in five patients (2."	( Safety of withholding intubation in gamma-hydroxybutyrate- and gamma-butyrolactone-intoxicated coma patients in the emergency department. Gresnigt, FMJ; van Helmond, LPFM, 2020)	0.56
"To determine the time course and duration of common, early-onset treatment-emergent adverse events (TEAEs) associated with sodium oxybate (SXB) use in adults with narcolepsy."	( Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy. Black, J; Bujanover, S; Husain, AM; Profant, J; Ryan, R; Scheckner, B, 2020)	0.56
" The most common treatment-emergent adverse events with LXB were headache (20."	( Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. Bogan, RK; Dauvilliers, Y; Del Rio Villegas, R; Foldvary-Schaefer, N; Partinen, M; Skobieranda, F; Skowronski, R; Šonka, K; Tang, L; Thorpy, MJ, 2021)	0.62
" Adverse events were assessed in the safety population (defined as all participants who took at least one dose of study medication)."	( Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Arnulf, I; Black, J; Bogan, RK; Chandler, P; Chen, D; Dauvilliers, Y; Foldvary-Schaefer, N; Mignot, E; Morse, AM; Parvataneni, R; Skobieranda, F; Šonka, K; Sterkel, A; Thorpy, MJ, 2022)	0.72
" Treatment-emergent adverse events included nausea (34 [22%] of 154), headache (27 [18%] of 154), dizziness (19 [12%] of 154), anxiety (17 [11%] 154), and vomiting (17 [11%] 154)."	( Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Arnulf, I; Black, J; Bogan, RK; Chandler, P; Chen, D; Dauvilliers, Y; Foldvary-Schaefer, N; Mignot, E; Morse, AM; Parvataneni, R; Skobieranda, F; Šonka, K; Sterkel, A; Thorpy, MJ, 2022)	0.72
"Co-use of ethanol with CNS-depressant drugs appears to increase the risk of adverse effects and is associated with a higher need for medical treatment, especially when ethanol is combined with opioids or GHB/GBL."	( Clinical effect of ethanol co-use in patients with acute drug toxicity involving the use of central nervous system depressant recreational drugs. Dargan, PI; Dines, AM; Erik Hovda, K; Eyer, F; Geith, S; Giraudon, I; Heier, EC; Heyerdahl, F; Liechti, ME; Miró, Ò; Rabe, C; Vallersnes, OM; Wood, DM; Yates, C; Zellner, T, 2022)	0.72
" Safety outcomes included treatment-emergent adverse events; assessments of depression, anxiety, and suicidality; and polysomnography."	( Long-term safety and maintenance of efficacy of sodium oxybate in the treatment of narcolepsy with cataplexy in pediatric patients. Black, J; Dauvilliers, Y; Guinta, D; Lecendreux, M; Mignot, E; Parvataneni, R; Plazzi, G; Rosen, CL; Ruoff, C; Wang, YG, 2022)	0.72
" Treatment-emergent adverse events (≥ 5%) were enuresis, nausea, vomiting, headache, decreased weight, decreased appetite, nasopharyngitis, upper respiratory tract infection, and dizziness."	( Long-term safety and maintenance of efficacy of sodium oxybate in the treatment of narcolepsy with cataplexy in pediatric patients. Black, J; Dauvilliers, Y; Guinta, D; Lecendreux, M; Mignot, E; Parvataneni, R; Plazzi, G; Rosen, CL; Ruoff, C; Wang, YG, 2022)	0.72
" During periods 1 and 2, the most common side effect was headache."	( Long-Term Safety and Tolerability During a Clinical Trial and Open-Label Extension of Low-Sodium Oxybate in Participants with Narcolepsy with Cataplexy. Bogan, RK; Chen, A; Foldvary-Schaefer, N; Skowronski, R; Thorpy, MJ, 2023)	0.91
" Treatment-emergent adverse events were collected throughout the OLE."	( Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia. Arnulf, I; Black, J; Bogan, RK; Chandler, P; Chen, A; Dauvilliers, Y; Foldvary-Schaefer, N; Hickey, L; Morse, AM; Thorpy, MJ, 2023)	0.91
" REMS can have elements to assure safe use (ETASU), such as patient registries, dispensing restrictions, and physician training and certification requirements."	( Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use. Abdurrob, A; Brown, BL; Dejene, SZ; Kesselheim, AS; McGraw, SA; Sarpatwari, A, 2023)	0.91

Excerpt	Reference	Relevance
" Doubling of the dose also resulted in a significant increase in tmax with little change in Cmax."	( Pharmacokinetics of gamma-hydroxybutyric acid in alcohol dependent patients after single and repeated oral doses. Castagna, F; Ferrara, SD; Frison, G; Gallimberti, L; Gessa, GL; Palatini, P; Tedeschi, L; Zotti, S, 1992)	0.28
" The pharmacokinetic model of thiopental is a three compartment model."	( [Pharmacokinetics of intravenous non-steroidal anesthetics]. Chardon, P; Kienlen, J, 1981)	0.26
" A two-compartment model with Michaelis-Menten elimination was fitted to the concentration-time data and a sigmoid E(max) model to the electroencephalographic effect effect site concentration curve allowing the study of the end organ sensitivity."	( Influence of hypovolemia on the pharmacokinetics and electroencephalographic effect of gamma-hydroxybutyrate in the rat. Belpaire, FM; Boon, PA; Buylaert, WA; De Paepe, P; Van Sassenbroeck, DK, 2002)	0.31
" This difference with propofol may be due to the fact that it increases blood pressure but also due to its different pharmacokinetic properties."	( Influence of hypovolemia on the pharmacokinetics and electroencephalographic effect of gamma-hydroxybutyrate in the rat. Belpaire, FM; Boon, PA; Buylaert, WA; De Paepe, P; Van Sassenbroeck, DK, 2002)	0.31
" The aim of this study was to investigate whether tolerance is also observed for the EEG effect, and whether the EEG can give insight into the pharmacodynamic aspects of GHB tolerance."	( Tolerance to the hypnotic and electroencephalographic effect of gamma-hydroxybutyrate in the rat: pharmacokinetic and pharmacodynamic aspects. Belpaire, FM; Boon, PA; Buylaert, WA; De Paepe, P; Van Sassenbroeck, DK, 2003)	0.32
" Noncompartmental methods were applied in the determination of pharmacokinetic parameters from each patient's plasma oxybate concentration versus time curve."	( The pharmacokinetics of sodium oxybate oral solution following acute and chronic administration to narcoleptic patients. Borgen, LA; Lai, A; Okerholm, RA; Scharf, MB, 2004)	0.32
" The aim of this controlled clinical study was to acquire pharmacokinetic profiles, detection times, and excretion rates in human subjects."	( Pharmacokinetics and excretion of gamma-hydroxybutyrate (GHB) in healthy subjects. Brenneisen, R; Elsohly, MA; Murphy, TP; Passarelli, J; Russmann, S; Salamone, SJ; Watson, DE, )	0.13
" The pharmacodynamic parameter sleep time in rats after GHB administration was recorded."	( Pharmacokinetic interaction between the flavonoid luteolin and gamma-hydroxybutyrate in rats: potential involvement of monocarboxylate transporters. Morris, ME; Wang, Q; Wang, X, 2008)	0.35
" Several studies have attempted to characterize GHB's pharmacokinetic properties in humans, and the aim of this paper is to build on this research with an emphasis on DFSA cases."	( Pharmacokinetic properties of γ-hydroxybutyrate (GHB) in whole blood, serum, and urine. Brailsford, AD; Cowan, DA; Kicman, AT, 2012)	0.38
" This study evaluated the pharmacodynamic interaction of SMO."	( Pharmacodynamic interactions of a solid formulation of sodium oxybate and ethanol in healthy volunteers. Bidaut, M; Fauchoux, N; Patat, A; Pross, N; Vivet, P, 2015)	0.42
" We characterized the pharmacokinetic profile and exposure-psychotropic effect relationship of GHB in humans."	( Pharmacokinetics and pharmacodynamics of γ-hydroxybutyrate in healthy subjects. Bosch, OG; Dornbierer, D; Gachet, MS; Gertsch, J; Liakoni, E; Liechti, ME; Quednow, BB; Seifritz, E; von Rotz, R, 2016)	0.43
" The purpose of the following studies was to evaluate the pharmacokinetic properties, safety profile, and tolerability of FT218 in healthy adults."	( Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults. Dubow, J; Seiden, D; Tyler, C, 2021)	0.62
" In this study, we investigated locomotor behavior as well as metabolic and pharmacokinetic interactions following co-administration of GHB and ethanol in rats."	( Alcohol perturbed locomotor behavior, metabolism, and pharmacokinetics of gamma-hydroxybutyric acid in rats. Bae, JW; Choi, B; Ji, M; Kim, M; Kim, S; Lee, S; Lee, YS; Oh, S; Paik, MJ, 2023)	0.91

Excerpt	Reference	Relevance
"Total intravenous anaesthesia (TIVA) using propofol, gamma-hydroxybutyrate (GHB) or midazolam in combination with sufentanil was investigated in 45 patients undergoing coronary artery bypass grafting (CABG)."	( Total intravenous anaesthesia using propofol, gamma-hydroxybutyrate or midazolam in combination with sufentanil for patients undergoing coronary artery bypass surgery. Grundmann, U; Janneck, U; Kleinschmidt, S; Kreienmeyer, J; Kulosa, R; Larsen, R, 1997)	0.3
" GHB is frequently combined with other recreational drugs although these interactions are not well characterised."	( Sedative and hypothermic effects of gamma-hydroxybutyrate (GHB) in rats alone and in combination with other drugs: assessment using biotelemetry. McGregor, IS; van Nieuwenhuijzen, PS, 2009)	0.35
"Data ascertained in a study of club drug use among 450 gay and bisexual men indicate that at least one class of PDE-5 (phosphodiesterase type 5 inhibitor, sildenafil [Viagra]) is used frequently in combination with club drugs such as methamphetamine, MDMA (3,4 methylenedioxymethamphetamine [ecstasy]), ketamine, cocaine, and GHB (gamma hydroxy butyrate)."	( Sildenafil (Viagra) and club drug use in gay and bisexual men: the role of drug combinations and context. Green, KA; Halkitis, PN, 2007)	0.34
"To study the profile of European gamma-hydroxybutyrate (GHB) and gammabutyrolactone (GBL) intoxication and analyse the differences in the clinical manifestations produced by intoxication by GHB/GBL alone and in combination with other substances of abuse."	( Intoxication by gamma hydroxybutyrate and related analogues: Clinical characteristics and comparison between pure intoxication and that combined with other substances of abuse. Chevillard, L; Dargan, P; Dines, AM; Eyer, F; Galicia, M; Giraudon, I; Heyerdahl, F; Homar, C; Hovda, KE; Jürgens, G; Kabata, PM; Lee, C; Liakoni, E; Liechti, M; Markey, G; Mégarbane, B; Miró, Ò; Moughty, A; O'Connor, N; O'Donohoe, P; Paasma, R; Pedersen, CB; Persett, PS; Põld, K; Puiguriguer, J; Rabe, C; Sein Anand, J; Vallersnes, OM; Waring, WS; Wood, DM; Yates, C, 2017)	0.46
"7% consumed GHB/GBL in combination with other substances of abuse, the most frequent additional agents being ethanol (50%), amphetamine derivatives (36%), cocaine (12%) and cannabis (8%)."	( Intoxication by gamma hydroxybutyrate and related analogues: Clinical characteristics and comparison between pure intoxication and that combined with other substances of abuse. Chevillard, L; Dargan, P; Dines, AM; Eyer, F; Galicia, M; Giraudon, I; Heyerdahl, F; Homar, C; Hovda, KE; Jürgens, G; Kabata, PM; Lee, C; Liakoni, E; Liechti, M; Markey, G; Mégarbane, B; Miró, Ò; Moughty, A; O'Connor, N; O'Donohoe, P; Paasma, R; Pedersen, CB; Persett, PS; Põld, K; Puiguriguer, J; Rabe, C; Sein Anand, J; Vallersnes, OM; Waring, WS; Wood, DM; Yates, C, 2017)	0.46
" The clinical features are more severe when GHB is consumed in combination with other substances of abuse."	( Intoxication by gamma hydroxybutyrate and related analogues: Clinical characteristics and comparison between pure intoxication and that combined with other substances of abuse. Chevillard, L; Dargan, P; Dines, AM; Eyer, F; Galicia, M; Giraudon, I; Heyerdahl, F; Homar, C; Hovda, KE; Jürgens, G; Kabata, PM; Lee, C; Liakoni, E; Liechti, M; Markey, G; Mégarbane, B; Miró, Ò; Moughty, A; O'Connor, N; O'Donohoe, P; Paasma, R; Pedersen, CB; Persett, PS; Põld, K; Puiguriguer, J; Rabe, C; Sein Anand, J; Vallersnes, OM; Waring, WS; Wood, DM; Yates, C, 2017)	0.46
"Neither pharmacokinetic nor pharmacodynamic drug-drug interactions between cobicistat and GHB were identified in this study."	( Absence of drug-drug interactions between γ-hydroxybutyric acid (GHB) and cobicistat. Bailón, L; Farré, M; Martín, S; Miranda, C; Moltó, J; Mothe, B; Papaseit, E; Pérez-Mañá, C, 2021)	0.62
" GHB shows a biphasic effect and dose-dependent pharmacokinetics and may interact with neuronal systems different from GABAergic one."	( Evaluating the risk of toxicity and adverse drug interactions involving recreational GHB use and prescribed drugs. Brunetti, P; Busardò, FP; Gibelli, F; Ricci, G; Sirignano, A, 2021)	0.62

Excerpt	Reference	Relevance
" However, food significantly altered the bioavailability of oxybate by decreasing mean peak plasma concentration, increasing median time-to-peak concentration, and decreasing the area under the plasma concentration-time curve."	( The influence of gender and food on the pharmacokinetics of sodium oxybate oral solution in healthy subjects. Borgen, LA; Lai, A; Morrison, D; Okerholm, R, 2003)	0.32
" Ethanol coingestion resulted in 16% higher GHB maximal plasma concentration and 29% longer elimination half-life, indicating possible enhanced bioavailability or reduced clearance of GHB caused by ethanol, however, these effects were not statistically significant."	( Gamma-hydroxybutyrate and ethanol effects and interactions in humans. Benowitz, NL; Dyer, JE; Haller, CA; Thai, D, 2006)	0.33
" As GBL shows a higher lipophilicity than GHB, it is absorbed more quickly, its bioavailability is higher and its effects are faster than those of GHB."	( Replacing GHB with GBL in Recreational Settings: A New Trend in Chemsex. Busardò, FP; Gottardi, M; Marinelli, E; Minutillo, A; Sirignano, A; Tini, A; Zaami, S, 2018)	0.48
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."	( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019)	0.51
"5, and 9 g; the third, a relative bioavailability study (n = 28) that compared FT218 6 g with twice-nightly SO 6 g (2 divided doses of 3 g); and the fourth, a food-effect study (n = 16) of FT218 6 g."	( Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults. Dubow, J; Seiden, D; Tyler, C, 2021)	0.62

Excerpt	Relevance	Reference
" Oral absorption of NaGHB appeared to be fairly extensive in the dose range studied (200-1600 mg/kg), but the peak drug plasma concentrations achieved after oral dosing were relatively low and insensitive to changes in the magnitude of the dose, explaining the lack of pharmacological activity, viz."	( Dose-dependent pharmacokinetics and hypnotic effects of sodium gamma-hydroxybutyrate in the rat. Fung, HL; Lettieri, JT, 1979)	0.26
" No clear dose-response effect was observed; this may be attributable to differences in susceptibility, wide variations in doses taken by the same person, or the coingestion of other substances."	( Acute poisoning from gamma-hydroxybutyrate in California. Chin, MY; Dyer, JE; Kreutzer, RA, 1992)	0.28
" The regional concentration of both compounds in brain was determined in time-course and dose-response studies, as well as at the onset of EEG changes, induced by both GHB and GBL."	( The gamma-hydroxybutyrate model of absence seizures: correlation of regional brain levels of gamma-hydroxybutyric acid and gamma-butyrolactone with spike wave discharges. Snead, OC, 1991)	0.28
" Piracetam abolished the amnestic effect of proline cethyl ester while sodium hydroxybutyrate administered in the dosage range provoking the nootropic effect did not change that amnesia."	( [Antagonism of piracetam with proline in relation to mnestic effects]. Gudasheva, TA; Ostrovskaia, RU; Skoldinov, AP; Trofimov, SS; Tsybina, NM, 1985)	0.27
"The effects of gamma-hydroxybutyrate (GHB) upon sleep wakefulness patterns and quantified nuchal muscle activity were examined in the rabbit in a dose-response paradigm (25-1,000 mg/kg)."	( EEG and behavioral effects of gamma-hydroxybutyrate in the rabbit. Godbout, R; Pivik, RT, 1982)	0.26
" Antihypoxic effect of the drug manifests within a wide dosage range (100-1000 mg/kg) and compares favourably with the effect of sodium hydroxybutyrate."	( [Effect of mebikar on the state of animals under extreme conditions]. Kamburg, RA; Kirshin, SV; Zimakova, IE, )	0.13
" In addition, the dose-response characteristics of modulation of the cytokine response by GHB was studied in vitro in the same assay."	( [The effect of gamma-hydroxybutyrate (GHB) on proinflammatory cytokine gene expression in coronary surgical procedures]. Bauer, M; Bussmann, D; Kleinschmidt, S; Larsen, R; Menger, MD; Wanner, G; Ziegenfuss, T, 1998)	0.3
"Symptoms of the autonomic nervous system were more effectively prevented by GHB as evident in the lower dosage requirement of clonidine."	( [Gamma-hydroxybutyrate for treatment of alcohol withdrawal syndrome in intensive care patients. A comparison between with two symptom-oriented therapeutic concepts]. Lenzenhuber, E; Müller, C; Rommelspacher, H; Spies, C, 1999)	0.3
" Dose-response curves were attained in each group with its respective training drugs."	( Discrimination of gamma-hydroxybutyrate and ethanol administered separately and as a mixture in rats. Allen, JD; Metcalf, BR; Soto, PL; Stahl, JM; Woolfolk, DR, 2001)	0.31
" The pharmacokinetics of MDMA and GHB appear to be nonlinear, making it difficult to estimate a dose-response relationship."	( A comprehensive review of MDMA and GHB: two common club drugs. Guthrie, SK; Teter, CJ, 2001)	0.31
" The frequency of inadvertent naps/sleep attacks and the nighttime awakenings showed similar dose-response trends, becoming significant at the 9 g dose (p=0."	( A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. , 2002)	0.31
" Although significant food effects were observed, these are minimized in patients by the nocturnal dosing of sodium oxybate hours after the evening meal at a consistent time interval following food ingestion."	( The influence of gender and food on the pharmacokinetics of sodium oxybate oral solution in healthy subjects. Borgen, LA; Lai, A; Morrison, D; Okerholm, R, 2003)	0.32
" However, there are reports of withdrawal following chronic abuse of illicit GHB which involve escalating both doses and dosing frequency."	( The abrupt cessation of therapeutically administered sodium oxybate (GHB) does not cause withdrawal symptoms. , 2003)	0.32
"The authors studied and described the effect of chronic dosing of GHB (3-6 days) on tolerance and withdrawal in a rat model."	( Gamma-hydroxybutyric acid tolerance and withdrawal in a rat model. Ashar, T; Bania, TC; Carey, PM; Press, G, 2003)	0.32
" Groups of rats (2 per group) were dosed with GHB for either 3 (24 doses), 4 (32 doses), 5 (40 doses), or 6 (48 doses) days."	( Gamma-hydroxybutyric acid tolerance and withdrawal in a rat model. Ashar, T; Bania, TC; Carey, PM; Press, G, 2003)	0.32
"Tolerance: Rats dosed with GHB for more days were less intoxicated one hour after their last GHB dose despite receiving higher doses."	( Gamma-hydroxybutyric acid tolerance and withdrawal in a rat model. Ashar, T; Bania, TC; Carey, PM; Press, G, 2003)	0.32
" More prolonged dosing and higher doses of GHB may be necessary to induce severe withdrawal."	( Gamma-hydroxybutyric acid tolerance and withdrawal in a rat model. Ashar, T; Bania, TC; Carey, PM; Press, G, 2003)	0.32
" Group 1--bolus dosing of a 20% solution of gamma oxy-oil acid (GOOA), 75-100 mg/kg; group 2--bolus dosing of a 1% solution of thiopental sodium (5-7 mg/kg); and group 3--micro-flow introduction of dormycum (0."	( [Central hemodynamics during therapeutic sedation in children under artificial pulmonary ventilation]. Nikitin, VV; Ostreĭkov, IF; Petrova, ZhI; Shtatnov, MK; Tarasov, SV, )	0.13
" Estimating the dosage of liquid GHB is especially difficult leading to unintentional intoxication because the exact concentration is not known."	( [gamma-Hydroxybutyrate intoxication]. Hahne, N; Nebel, BW; Weinmann, W, 2004)	0.32
" Pretreatment with SCH 50911 resulted in a significant shift to the right of the dose-response curve of gamma-hydroxybutyric acid-induced mortality."	( Protection by the GABAB receptor antagonist, SCH 50911, of gamma-hydroxybutyric acid-induced mortality in mice. Carai, MA; Colombo, G; Gessa, GL, 2004)	0.32
" Some adverse events reported demonstrated a clear dose-response relationship."	( Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients. , 2005)	0.33
" The improvements in cataplexy are dependent on the dosage of sodium oxybate as well on the duration of treatment."	( Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients. , 2005)	0.33
"To review the pharmacology, pharmacokinetics, clinical efficacy, adverse effects, drug interactions, precautions, dosing recommendations, and patient counseling of sodium oxybate for the treatment of cataplexy in patients with narcolepsy."	( Sodium oxybate for cataplexy. Farver, DK; Lemon, MD; Strain, JD, 2006)	0.33
" Potential disadvantages include a multiple dosing regimen, abuse potential, cost, and a closed distribution system."	( Sodium oxybate for cataplexy. Farver, DK; Lemon, MD; Strain, JD, 2006)	0.33
" Baclofen shifted the flumazenil dose-response curve to the right and down, possibly involving perceptual masking of the discriminative stimulus effects of flumazenil by agonist activity at GABAB receptors."	( Discriminative stimulus effects of flumazenil: perceptual masking by baclofen, and lack of substitution with gamma-hydroxybutyrate and its precursors 1,4-butanediol and gamma-butyrolactone. Carter, LP; Coop, A; France, CP; Koek, W; Wu, H, 2006)	0.33
"5 to 4 hours later for 4 weeks during the stable dosing phase."	( A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy. Cuellar, N; Weaver, TE, 2006)	0.33
" GBL dosing was initiated at 100 mg/kg/day and then progressively increased stepwise by increments of 100 mg/kg to a final dose of 600 mg/kg."	( Chronic intragastric administration of gamma-butyrolactone produces physical dependence in baboons. Brown, PR; Froestl, W; Gibson, KM; Goodwin, AK; Griffiths, RR; Jakobs, C; Weerts, EM, 2006)	0.33
" Signs of physical dependence were also demonstrated when chronic GBL dosing was discontinued."	( Chronic intragastric administration of gamma-butyrolactone produces physical dependence in baboons. Brown, PR; Froestl, W; Gibson, KM; Goodwin, AK; Griffiths, RR; Jakobs, C; Weerts, EM, 2006)	0.33
"These data indicate that, like GHB, chronic GBL dosing produced physical dependence that likely involved the GABA-B receptor."	( Chronic intragastric administration of gamma-butyrolactone produces physical dependence in baboons. Brown, PR; Froestl, W; Gibson, KM; Goodwin, AK; Griffiths, RR; Jakobs, C; Weerts, EM, 2006)	0.33
" Pulse oximetry readings were lower 45 min after BD dosing with a mean oxygen saturation of 98."	( Clinical pharmacology of 1,4-butanediol and gamma-hydroxybutyrate after oral 1,4-butanediol administration to healthy volunteers. Dyer, JE; Haller, CA; Jacob, P; Thai, D, 2007)	0.34
" At 100 mg/kg, CGP35348 shifted the dose-response curves of baclofen and SKF97541 to the right but not those of GHB and GBL; at 320 mg/kg, CGP35348 shifted the curves of all four compounds to the right."	( Cataleptic effects of gamma-hydroxybutyrate (GHB), its precursor gamma-butyrolactone (GBL), and GABAB receptor agonists in mice: differential antagonism by the GABAB receptor antagonist CGP35348. Coop, A; Koek, W; Mercer, SL, 2007)	0.34
" Because of the unusually steep dose-response curves, accidental GHB overdosing, leading to coma, seizures or death can occur."	( Determination of gamma-hydroxybutyrate (GHB) and its precursors in blood and urine samples: a salting-out approach. Ariniemi, K; Kankaanpää, A; Liukkonen, R, 2007)	0.34
" Dose-response functions determined with both training compounds revealed a clear dissociation between the discriminative stimulus effects of these drugs."	( Differentiating the discriminative stimulus effects of gamma-hydroxybutyrate and ethanol in a three-choice drug discrimination procedure in rats. Baker, LE; Poling, A; Pynnonen, DM; Searcy, GD, 2008)	0.35
" Ketamine, PCP, and MK-801 enhanced catalepsy along inverted U-shaped dose-response curves likely because higher doses affected motor coordination, which limited their catalepsy-enhancing effects."	( Cataleptic effects of gamma-hydroxybutyrate (GHB) and baclofen in mice: mediation by GABA(B) receptors, but differential enhancement by N-methyl-d-aspartate (NMDA) receptor antagonists. France, CP; Koek, W, 2008)	0.35
" Given that humans most commonly ingest both drugs orally, we examined the dose-response relationships for intragastrically administered GHB and BDL on MAP and heart rate in conscious rats using radiotelemetry."	( Cardiovascular responses elicited by intragastric administration of BDL and GHB. Hicks, AR; Varner, KJ, 2008)	0.35
" Information for health professionals and workers in forensic structures as well as education of the general population associated with preventive measures such as drug dosage form changes should contribute to improved care management of victims and decreased risk."	( Chemical submission: results of 4-year French inquiry. Burin, E; Dally, S; Djezzar, S; Questel, F, 2009)	0.35
" CGP35348 shifted the dose-response curve of each agonist to the right, but the magnitude of the shift differed among the agonists."	( Behavioral effects of gamma-hydroxybutyrate, its precursor gamma-butyrolactone, and GABA(B) receptor agonists: time course and differential antagonism by the GABA(B) receptor antagonist 3-aminopropyl(diethoxymethyl)phosphinic acid (CGP35348). Coop, A; France, CP; Koek, W; Mercer, SL, 2009)	0.35
" After the intake of a low dosage of a particular drug, those methods allow to detect the analyte of interest up to 3-5 days in blood, 10-15 days in urine, and more than 1 year in hair."	( [Analytical, toxicological and forensic aspects of drug-facilitated crimes: 10 years of experience]. Pépin, G, 2010)	0.36
" These results offer an explanation for the steep dose-response curve of GHB seen in vivo, and suggest potential target receptors for further investigation."	( γ-Hydroxybutyrate and the GABAergic footprint: a metabolomic approach to unpicking the actions of GHB. Balcar, VJ; Hanrahan, JR; Maher, AD; Nasrallah, FA; Rae, CD, 2010)	0.36
" Locomotor activity and body weight were assessed during the dosing period and withdrawal-related anxiety was assessed 24 h after drug cessation."	( Residual social, memory and oxytocin-related changes in rats following repeated exposure to γ-hydroxybutyrate (GHB), 3,4-methylenedioxymethamphetamine (MDMA) or their combination. Arnold, JC; Hunt, GE; Long, LE; McGregor, IS; van Nieuwenhuijzen, PS, 2010)	0.36
" Due to dosing difficulty and side effects, regular use was discontinued."	( A web-based study of gamma hydroxybutyrate (GHB): patterns, experiences, and functions of use. Bryant, M; Clair, M; Lebeau, R; Martin, R; Monti, P; Stein, LA; Storti, S, )	0.13
" Baclofen (GABA(B) agonist) has not been associated with dependence or misuse and has been effective in several trials in preventing relapse, although research is required to establish the optimal dosing regimen."	( Substitution therapy for alcoholism: time for a reappraisal? Chick, J; Nutt, DJ, 2012)	0.38
" The effect may be variable, due to a steep dose-response curve and interaction with alcohol and other intoxicants."	( [Abuse of γ-hydroxybutyrate]. Bramness, JG; Haugland, S, 2011)	0.37
"Overdose of γ-hydroxybutyrate (GHB) frequently causes respiratory depression, occasionally resulting in death; however, little is known about the dose-response relationship or effects of potential overdose treatment strategies on GHB-induced respiratory depression."	( γ-Hydroxybutyrate (GHB)-induced respiratory depression: combined receptor-transporter inhibition therapy for treatment in GHB overdose. Morris, ME; Morse, BL; Vijay, N, 2012)	0.38
" Dosing was initiated at 100 mg/kg and increased by 100mg/kg/day to 400mg/kg."	( Physical dependence on gamma-hydroxybutrate (GHB) prodrug 1,4-butanediol (1,4-BD): time course and severity of withdrawal in baboons. Gibson, KM; Goodwin, AK; Weerts, EM, 2013)	0.39
" Mice were implanted for EEG/EMG monitoring and dosed with GHB (150 mg/kg), R-BAC (2."	( GABAB agonism promotes sleep and reduces cataplexy in murine narcolepsy. Black, SW; Chen, TM; Kilduff, TS; Leung, AK; Morairty, SR; Wisor, JP; Yamanaka, A, 2014)	0.4
" As relatively new drugs on the gay scene, understanding of appropriate dosing was lacking and a majority described overdoses, particularly in relation to GHB/GBL."	( "Chemsex" and harm reduction need among gay men in South London. Bourne, A; Hickson, F; Reid, D; Steinberg, P; Torres-Rueda, S; Weatherburn, P, 2015)	0.42
" Most of the studies evaluating the efficacy of GHB in the treatment of AWS use a dosage of 50 mg/kg divided in three or four administrations per day."	( Clinical applications of sodium oxybate (GHB): from narcolepsy to alcohol withdrawal syndrome. Busardò, FP; Kyriakou, C; Marinelli, E; Napoletano, S; Zaami, S, 2015)	0.42
"To determine effects of chronic GHB dosing on GHB toxicokinetics, GHB-induced respiratory depression, and MCT expression."	( Effect of chronic γ-hydroxybutyrate (GHB) administration on GHB toxicokinetics and GHB-induced respiratory depression. Chadha, GS; Felmlee, MA; Follman, KE; Morris, ME; Morse, BL, 2017)	0.46
" Both responder definitions showed a dose-response relationship with sodium oxybate, demonstrating their validity using an external criterion."	( Criteria for gauging response to sodium oxybate for narcolepsy. Lai, C; Steffen, AD; Weaver, TE, 2018)	0.48
" Here we present a case of GHB withdrawal delirium that was treated successfully with fixed and symptom-triggered benzodiazepine dosing regimen based on Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) scale."	( Clinical management of gamma-hydroxybutyrate (GHB) withdrawal delirium with CIWA-Ar protocol. Chang, HM; Chen, LY; Liao, PC, 2018)	0.48
"In this large postauthorization safety study of sodium oxybate use, indication and dosage prescribing recommendations were generally followed, and most patients complied with instructions, with deviations around alcohol consumption, eating before dosing and timing."	( Long-term compliance, safety, and tolerability of sodium oxybate treatment in patients with narcolepsy type 1: a postauthorization, noninterventional surveillance study. Bentz, JWG; Iranzo, Á; Mayer, G; Ortega-Albás, J; Pesch, H; Plazzi, G; Quinnell, T; Schlit, AF; Serralheiro, P; Wuiame, D, 2018)	0.48
" The efficacy population consisted of all participants randomly assigned to receive an intervention who completed at least 5 days of dosing in the double-blind treatment period, and the safety population consisted of all participants who took the study drug, including open-label sodium oxybate."	( Treatment of paediatric narcolepsy with sodium oxybate: a double-blind, placebo-controlled, randomised-withdrawal multicentre study and open-label investigation. Black, J; Dauvilliers, Y; Guinta, D; Lecendreux, M; Mignot, E; Parvataneni, R; Plazzi, G; Rosen, CL; Ruoff, C; Wang, YG, 2018)	0.48
"The elimination half-life of GHB in blood samples from apprehended drivers was longer than expected compared with results of controlled dosing studies."	( Rate of elimination of γ-hydroxybutyrate from blood determined by analysis of two consecutive samples from apprehended drivers in Norway. Årnes, M; Bachs, L; Høiseth, G; Jones, AW; Sammarai, MA, 2020)	0.56
" The aim of this study was to investigate whether a regular intake of a known dosage of GHB leads to elevated levels of GHB concentration in hair."	( Levels of GHB in hair after regular application. Heidbreder, A; Hess, C; Martz, W; Mayer, G; Nebel, A; Veit, F, 2021)	0.62
" In conclusion, a moderate dose-effect relationship was observed, although, there was some overlap in dosage concentration levels of GHB in awake and comatose patients."	( Characteristics and dose-effect relationship of clinical gamma-hydroxybutyrate intoxication: A case series. Abid, M; Andresen-Streichert, H; Iwersen-Bergmann, S; Kietzerow, J; Schnitgerhans, T, 2022)	0.72
" This highlights the need for prospective trials to establish an evidence base for therapeutic approaches, including validated measures of withdrawal severity and more information relating to the safe and effective dosing of phenobarbital."	( Phenobarbital to manage severe gamma-hydroxybutyrate withdrawal: A case series. Brett, J; Ezard, N; Freeman, G; Nic Ionmhain, U; Ramanathan, J; Roberts, DM; Rodgers, C; Siefried, KJ, 2023)	0.91
" Patients were randomized 1:1 to receive SXB during a 4-week titration followed by a 4-week stable dosing period."	( Sodium oxybate in treatment-resistant rapid-eye-movement sleep behavior disorder. Cahuas, A; During, EH; Ekelmans, A; Hekmat, A; Hernandez, B; Kushida, CA; Miglis, MG; Mignot, E; Sum-Ping, O; Yoshino, F, 2023)	0.91
"Clinicians indicated a significantly higher preference for the once-at-bedtime dosing schedule versus twice nightly in selecting oxybate therapies overall and when aiming to improve patient QoL or reduce patient anxiety."	( Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment. Athavale, A; Flygare, J; Gudeman, J; Krahn, L; Kushida, C; Morse, AM; Thorpy, MJ, 2023)	0.91

Protein	Taxonomy	Measurement	Average (µ)	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_a	Homo sapiens (human)	Potency	84.5691	0.0017	23.8393	78.1014	AID743083
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Free fatty acid receptor 3	Rattus norvegicus (Norway rat)	EC50 (µMol)	10,000.0000	5.0000	5.0000	5.0000	AID1341023
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Assay ID	Title	Year	Journal	Article
AID1219822	Cmax in Sprague-Dawley rat plasma at 600 mg/kg, iv after 30 to 180 mins	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219810	Increase of sleep time in Sprague-Dawley rat at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219785	Cmax in Sprague-Dawley rat plasma at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219804	Ratio of extracellular fluid of brain AUC to plasma AUC in Sprague-Dawley rat at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1597742	Half life in human at 2250 mg administered as two doses	2019	Bioorganic & medicinal chemistry letters, 08-15, Volume: 29, Issue:16	Sleep modulating agents.
AID1219802	AUC in Sprague-Dawley rat extracellular fluid of brain at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219816	Drug uptake in human hCMEC/D3 cells at pH 7.4 up to 10 mins by Michaelis-Menten analysis	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219795	Tmax in Sprague-Dawley rat extracellular fluid of brain at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219794	Tmax in Sprague-Dawley rat extracellular fluid of brain at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219793	Cmax in Sprague-Dawley rat extracellular fluid of brain at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219809	Increase of sleep time in Sprague-Dawley rat at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219800	AUC in Sprague-Dawley rat extracellular fluid of brain at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219818	Drug uptake in human hCMEC/D3 cells at 10 mM at pH 6.5 up to 10 mins by Michaelis-Menten analysis relative to at pH 7.4	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219820	Drug uptake in human hCMEC/D3 cells assessed as alpha-cyano-4-hydroxycinnamate-mediated mediated drug uptake at pH 6.5 up to 10 mins by Michaelis-Menten analysis	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219815	Drug uptake in rat RBE4 cells at pH 7.4 up to 10 mins by Michaelis-Menten analysis	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219823	Cmax in Sprague-Dawley rat plasma at 800 mg/kg, iv after 30 to 180 mins	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219811	Increase of sleep time in Sprague-Dawley rat at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219806	Renal clearance in Sprague-Dawley rat at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219787	Cmax in Sprague-Dawley rat plasma at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219797	AUC in Sprague-Dawley rat plasma at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219825	Drug recovery in Sprague-Dawley rat brain frontal cortex at 400 to 800 mg/kg, iv by microdialysis	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219803	Ratio of extracellular fluid of brain AUC to plasma AUC in Sprague-Dawley rat at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219796	Tmax in Sprague-Dawley rat extracellular fluid of brain at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219788	Tmax in Sprague-Dawley rat plasma at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219789	Tmax in Sprague-Dawley rat plasma at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219824	Dissociation constant, pKa of the compound	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219790	Tmax in Sprague-Dawley rat plasma at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219791	Cmax in Sprague-Dawley rat extracellular fluid of brain at 400 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219792	Cmax in Sprague-Dawley rat extracellular fluid of brain at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219817	Drug uptake in rat RBE4 cells at 10 mM at pH 6.5 up to 10 mins by Michaelis-Menten analysis relative to at pH 7.4	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219786	Cmax in Sprague-Dawley rat plasma at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219814	Drug uptake in human hCMEC/D3 cells at 58 nM at pH 7.4 after 15 to 30 seconds by liquid scintillation counting	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219807	Renal clearance in Sprague-Dawley rat at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219805	Ratio of extracellular fluid of brain AUC to plasma AUC in Sprague-Dawley rat at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219812	Increase of sleep time in iv dosed Sprague-Dawley rat	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219819	Drug uptake in rat RBE4 cells assessed as alpha-cyano-4-hydroxycinnamate-mediated mediated drug uptake at pH 6.5 up to 10 mins by Michaelis-Menten analysis	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219801	AUC in Sprague-Dawley rat extracellular fluid of brain at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219798	AUC in Sprague-Dawley rat plasma at 600 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219808	Renal clearance in Sprague-Dawley rat at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219799	AUC in Sprague-Dawley rat plasma at 800 mg/kg, iv	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219821	Cmax in Sprague-Dawley rat plasma at 400 mg/kg, iv after 30 to 180 mins	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1219813	Drug uptake in rat RBE4 cells at 58 nM at pH 7.4 after 15 to 30 seconds by liquid scintillation counting	2012	Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1	Brain uptake of the drug of abuse γ-hydroxybutyric acid in rats.
AID1296008	Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening	2020	SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1	Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986	P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987	P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID651635	Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	357 (21.20)	18.7374
1990's	260 (15.44)	18.2507
2000's	489 (29.04)	29.6817
2010's	401 (23.81)	24.3611
2020's	177 (10.51)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	0 (0.00%)	5.53%
Trials	136 (7.01%)	5.53%
Reviews	0 (0.00%)	6.00%
Reviews	240 (12.38%)	6.00%
Case Studies	0 (0.00%)	4.05%
Case Studies	241 (12.43%)	4.05%
Observational	0 (0.00%)	0.25%
Observational	13 (0.67%)	0.25%
Other	6 (100.00%)	84.16%
Other	1,309 (67.51%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (37)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease [NCT02111122]	Phase 2	16 participants (Actual)	Interventional	2014-04-30	Completed
The Gamma Hydroxybutyric Acid in Alcohol-dependence Treatment Efficacy (GATE) I Trial: a Comparative Study Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome [NCT02090504]	Phase 4	127 participants (Actual)	Interventional	2002-02-28	Completed
Open-label Clinical Trial to Evaluate the Efficacy of Sodium Oxybate (Xyrem®) in the Treatment of Two Under-recognized Clinical Conditions: Post-traumatic Narcolepsy and Post-traumatic Hypersomnia [NCT03626727]	Early Phase 1	0 participants (Actual)	Interventional	2020-09-30	Withdrawn(stopped due to Target study population was extremely difficult to recruit and planned study budget was exceeded)
Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy [NCT00066170]	Phase 3	231 participants (Actual)	Interventional	2003-04-30	Completed
Multimodal Characterization of the Prosocial and Prosexual Effects of GHB Assessing Behavior, fMRI, EEG, and Neuroendocrine Mechanisms [NCT02342366]		19 participants (Actual)	Interventional	2012-02-29	Completed
Does Xyrem Influence Brain Dopamine in Patients With Narcolepsy? A PET Imaging Investigation [NCT02637076]	Phase 4	17 participants (Actual)	Interventional	2016-01-31	Completed
Impact of Low Sodium Oxybate on Total Sleep Time in Patients With Idiopathic Hypersomnia [NCT05837091]	Phase 4	30 participants (Anticipated)	Interventional	2023-12-31	Recruiting
Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy [NCT00132873]	Phase 3	59 participants (Actual)	Interventional	2004-10-31	Completed
Sodium Oxybate Versus Midazolam for Comfort Sedation [NCT05085873]	Phase 4	22 participants (Actual)	Interventional	2021-10-14	Completed
Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean From Mechanical Ventilation [NCT04224246]	Phase 2	20 participants (Anticipated)	Interventional	2020-01-31	Not yet recruiting
Safety and Efficacy of Sodium Oxybate in the Prophylaxis of Headache and Sleep Disturbances in Patients With Chronic and Episodic Cluster Headache [NCT02637648]	Phase 3	60 participants (Anticipated)	Interventional	2015-12-31	Not yet recruiting
The Effect of Sodium Oxybate on Sleep Architecture in Critically Ill Patients: A Double-Blind, Crossover Pilot Study [NCT00744393]	Phase 2	0 participants (Actual)	Interventional	2008-10-31	Withdrawn(stopped due to Sponsor pulled funding secondary to economy issues)
Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia [NCT00803023]	Phase 3	129 participants (Actual)	Interventional	2010-03-31	Completed
A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease [NCT00641186]	Phase 2	30 participants (Actual)	Interventional	2004-09-30	Completed
Phase IV - A Trial of Xyrem in the Treatment of Chronic Fatigue Syndrome. [NCT00498485]	Phase 4	17 participants (Actual)	Interventional	2007-05-31	Terminated(stopped due to Withdrawal of support.)
Multinational, Multicentre, Double-blind, Placebo-controlled Evaluation of the Efficacy of GHB in the Long-term Maintenance of Abstinence in Alcoholic Patients After the Initial Weaning Phase, Stratified by Lesch's Taxonomy (GATE 2) [NCT04648423]	Phase 4	314 participants (Actual)	Interventional	2001-07-23	Completed
Phase IV Study Safety & Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients. [NCT00706186]	Phase 4	4 participants (Actual)	Interventional		Terminated(stopped due to Withdrawn by Investigator, protocol in revision)
A Double-Blind, Phase 1, Single-Center, Single-Ascending Dose Study of JZP-386 Compared to Xyrem® vs. Placebo to Evaluate the Safety and Pharmacokinetics [NCT02215499]	Phase 1	28 participants (Actual)	Interventional	2014-07-31	Completed
Multiple-dose, Double-blind, Placebo-controlled, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Sodium Oxybate (Xyrem) in Subjects With Moderate to Severe Essential Tremor [NCT00598078]	Phase 2	19 participants (Actual)	Interventional	2007-12-31	Completed
Enhancing Slow Wave Sleep With Sodium Oxybate to Reduce the Behavioral and Physiological Impact of Sleep Loss [NCT00506974]	Phase 4	60 participants (Actual)	Interventional	2007-05-31	Completed
Single-center Phase I/II Trial of Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO Trial) [NCT00931164]	Phase 1/Phase 2	6 participants (Actual)	Interventional	2009-08-31	Completed
Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) Durin [NCT00345800]	Phase 1	25 participants (Actual)	Interventional	2006-04-10	Completed
[NCT00514995]	Phase 2/Phase 3	15 participants (Anticipated)	Interventional	2007-08-31	Completed
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) With Placebo for the Treatment of Narcolepsy [NCT00049803]	Phase 3	200 participants	Interventional	2000-12-31	Completed
Physiological, Behavioral and Subjective Effects of Drugs (GHB) [NCT00058955]	Phase 1	20 participants (Anticipated)	Interventional	2003-08-31	Completed
Pharmacological Prevention of Post-traumatic Intrusions in Healthy Volunteers - Towards a Post-exposition Prophylaxis for Post-traumatic Stress Disorder [NCT04508166]		27 participants (Actual)	Interventional	2021-10-01	Completed
Central Mechanisms and Treatment Response of Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor [NCT03292458]	Phase 2/Phase 3	140 participants (Anticipated)	Interventional	2018-01-22	Active, not recruiting
Open Label, Pilot Study of Adjunctive Xyrem (Sodium Oxybate) for the Treatment of Schizophrenia and Associated Sleep Disturbances [NCT00594256]	Phase 2	8 participants (Actual)	Interventional	2008-05-31	Completed
A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Sodium Oxybate in Patients Affected With Idiopathic Hypersomnia [NCT03597555]	Phase 2/Phase 3	48 participants (Actual)	Interventional	2018-10-18	Completed
The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome. [NCT01584934]	Phase 4	0 participants (Actual)	Interventional	2013-06-30	Withdrawn(stopped due to incompatibilities over intellectual property)
Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial [NCT04006925]	Phase 4	24 participants (Actual)	Interventional	2019-09-10	Completed
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study. [NCT00383643]	Phase 2	48 participants (Actual)	Interventional	2006-05-31	Completed
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring [NCT05536011]		1,329 participants (Anticipated)	Observational [Patient Registry]	2021-08-24	Recruiting
Slow-wave Sleep and Daytime Functioning in Chronic Fatigue Syndrome: Effects of Sodium Oxybate [NCT02055898]	Phase 4	13 participants (Actual)	Interventional	2014-04-30	Completed
Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response [NCT01961297]	Phase 2	53 participants (Actual)	Interventional	2012-07-31	Completed
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem(R) (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia [NCT00087555]	Phase 2	195 participants (Actual)	Interventional	2004-07-31	Completed
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction [NCT02063217]		36 participants (Actual)	Interventional	2013-12-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00066170 (1) [back to overview]	Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
NCT00087555 (1) [back to overview]	The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).
NCT00132873 (2) [back to overview]	Adverse Experiences
NCT00132873 (2) [back to overview]	Vital Signs
NCT00345800 (36) [back to overview]	The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3
NCT00345800 (36) [back to overview]	The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4
NCT00345800 (36) [back to overview]	The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3
NCT00345800 (36) [back to overview]	The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4
NCT00345800 (36) [back to overview]	Cortisol Measured at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	Cortisol Measured at Visit 3
NCT00345800 (36) [back to overview]	Cortisol Measured at Visit 4
NCT00345800 (36) [back to overview]	Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3
NCT00345800 (36) [back to overview]	Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4
NCT00345800 (36) [back to overview]	The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3
NCT00345800 (36) [back to overview]	The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4
NCT00345800 (36) [back to overview]	The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3
NCT00345800 (36) [back to overview]	The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4
NCT00345800 (36) [back to overview]	The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3
NCT00345800 (36) [back to overview]	The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4
NCT00345800 (36) [back to overview]	The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3
NCT00345800 (36) [back to overview]	The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4
NCT00345800 (36) [back to overview]	The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)
NCT00345800 (36) [back to overview]	The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)
NCT00345800 (36) [back to overview]	The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
NCT00345800 (36) [back to overview]	The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study
NCT00345800 (36) [back to overview]	The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
NCT00345800 (36) [back to overview]	The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	The Osmolality Measured in Fasting Conditions at Visit 3
NCT00345800 (36) [back to overview]	The Osmolality Measured in Fasting Conditions at Visit 4
NCT00345800 (36) [back to overview]	The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)
NCT00345800 (36) [back to overview]	The Prolactin Measured in Fasting Conditions at Visit 3
NCT00345800 (36) [back to overview]	The Prolactin Measured in Fasting Conditions at Visit 4
NCT00345800 (36) [back to overview]	The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)
NCT00383643 (5) [back to overview]	Assessment of Clinical Global Impression-change.
NCT00383643 (5) [back to overview]	Assessment of Fatigue
NCT00383643 (5) [back to overview]	Assessment of Insomnia Severity Index
NCT00383643 (5) [back to overview]	Assessment of Pittsburgh Sleep Quality Index (PSQI)
NCT00383643 (5) [back to overview]	Assessment of Sleepiness
NCT00498485 (1) [back to overview]	Global Assessment of Change
NCT00594256 (5) [back to overview]	Epworth Sleepiness Scale
NCT00594256 (5) [back to overview]	MATRICS Neurocognitive Battery Composite
NCT00594256 (5) [back to overview]	Pittsburgh Sleep Quality Index
NCT00594256 (5) [back to overview]	Positive and Negative Syndrome Scale (PANSS) Negative Factor
NCT00594256 (5) [back to overview]	Slow Wave Sleep Minutes
NCT00598078 (1) [back to overview]	Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor
NCT00641186 (2) [back to overview]	Polysomnography (PSG)
NCT00641186 (2) [back to overview]	Sleep and Fatigue
NCT00803023 (1) [back to overview]	Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
NCT00931164 (1) [back to overview]	Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase
NCT01961297 (5) [back to overview]	Number of Participants Who Reported Positive Effects.
NCT01961297 (5) [back to overview]	Breathlessness Severity
NCT01961297 (5) [back to overview]	Number of Voice Breaks
NCT01961297 (5) [back to overview]	Voice Harshness Severity
NCT01961297 (5) [back to overview]	Voice Tremor Severity
NCT02055898 (4) [back to overview]	Daytime Sleepiness
NCT02055898 (4) [back to overview]	Daytime Sleepiness
NCT02055898 (4) [back to overview]	EEG Slow Wave Activity During Sleep
NCT02055898 (4) [back to overview]	EEG Slow Wave Activity During Sleep
NCT02063217 (1) [back to overview]	Percent Increase From Mean Baseline (07:00 to 19:00) of Cerebrospinal Fluid (CSF) Amyloid Beta During Sleep Induction and Sleep Deprivation Between 01:00 and 11:00 From Baseline
NCT02637076 (9) [back to overview]	% Change in PET [C-11] Dihydrotetrabenazine (DTBZ) Binding From Baseline to Five Hours Post Xyrem
NCT02637076 (9) [back to overview]	% Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem
NCT02637076 (9) [back to overview]	% Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem
NCT02637076 (9) [back to overview]	Blood Gamma-hydroxybutyrate (GHB) Cmax
NCT02637076 (9) [back to overview]	Blood Gamma-hydroxybutyrate (GHB) Concentration (AUC)
NCT02637076 (9) [back to overview]	Duration of Drowsiness
NCT02637076 (9) [back to overview]	[C-11]DTBZ BPND at 5 Hours Post Xyrem
NCT02637076 (9) [back to overview]	[C-11]Raclopride BPND at 1 Hour Post Xyrem
NCT02637076 (9) [back to overview]	[C-11]Raclopride BPND at 7 Hours Post Xyrem
NCT04006925 (6) [back to overview]	Number of Responders According to the CGI Efficacy Scale (CGI-E)
NCT04006925 (6) [back to overview]	Epworth Sleepiness Scale (ESS) Score
NCT04006925 (6) [back to overview]	Number of RBD Episodes in One Month (Per Patient RBD Log)
NCT04006925 (6) [back to overview]	Number of Severe of RBD Episodes in One Month (Per Patient RBD Log)
NCT04006925 (6) [back to overview]	RBD Episode Severity and Frequency During REM Sleep by Quantitative Video-PSG (Polysomnography) Analysis Per 10 Minutes of REM Sleep
NCT04006925 (6) [back to overview]	Number of Responders According to the CGI Improvement Scale (CGI-I)

Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)

The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint. (NCT00066170)
Timeframe: Baseline to Week 8

Intervention	Minutes (Mean)
Xyrem Placebo + Modafinil Placebo	-2.72
Xyrem + Modafinil Placebo	0.58
Xyrem Placebo + Modafinil at Established Dose	-0.53
Xyrem + Modafinil at Established Dose	2.68

Intervention	Percentage of Participants (Number)
	Responders	Non - Responders
Placebo	12.9	87.1
Xyrem (Sodium Oxybate) 4.5g	29.8	70.2
Xyrem (Sodium Oxybate) 6.0g	28.1	71.9

Intervention	ug/L (Mean)
	Bed time	1h	2h	4h	8h	12h	16h	20h
Sodium Oxybate	42.21	27.91	22.80	36.06	115.79	143.39	90.84	68.48

Intervention	ug/L (Mean)
	Pre-dose	1h	2h	4h	8h	12h	16h	20h
Sodium Oxybate	35.84	24.75	34.62	44.28	95.61	130.21	77.33	70.49

Intervention	ug/L (Mean)
	Pre-dose	1h	2h	4h	8h	12h	16h	20h
Sodium Oxybate	34.46	25.61	30.06	45.27	113.84	146.33	92.48	75.55

Intervention	mmol/L (Mean)
	Na (Sodium in mmol/L)	K (Potassium in mmol/L)	Ca (Calcium in mmol/L)
Sodium Oxybate	141.4	3.88	2.257

Intervention	ng/mL (Mean)
	Bed time	1h	2h	4h	8h	12h	16h	20h
Sodium Oxybate	1.821	1.225	1.408	1.236	0.576	0.293	0.309	0.313

Intervention	ng/mL (Mean)
	Pre-dose	1h	2h	4h	8h	12h	16h	20h
Sodium Oxybate	2.432	5.914	5.238	3.018	0.256	0.308	0.460	0.306

Intervention	ng/mL (Mean)
	Pre-dose	1h	2h	4h	8h	12h	16h	20h
Sodium Oxybate	0.816	3.804	3.864	2.712	0.224	0.420	0.296	0.244

Intervention	Points (Least Squares Mean)
Sodium Oxybate 1.5 Grams (A)	13.4
Sodium Oxybate 3 Grams (B)	10.8
Placebo (C)	13.0

Intervention	units on a scale (Mean)
	Mean Polysomnography Before Therapy	Mean Polysomnography After Therapy
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance	7	13

Intervention	units on a scale (Mean)
	Before Sodium Oxybate Therapy (baseline) ESS	After Sodium Oxybate Therapy (8 weeks) ESS	Before Sodium Oxybate Therapy (baseline) PSQI	After Sodium Oxybate Therapy (8 weeks) PSQI	Before Sodium Oxybate Therapy (baseline) FSS	After Sodium Oxybate Therapy (8 weeks) FSS	Before Sodium Oxybate Therapy (baseline) SF-36	After Sodium Oxybate Therapy (8 weeks) SF-36
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance	15.6	9.0	10.9	6.6	32.9	26.3	95.7	92.3

Intervention	participants (Number)
	Any Adverse Event	Gastrointestinal Disorders	Diarrhea	Nausea	Vomiting	General Disorders & Administration Site Conditions	Fatigue	Edema Peripheral	Infections & Infestation	Sinusitis	Urinary Tract Infection	Injury, Posioning, & Procedural Complications	Investigations	Metabolism & Nutrition Disorders	Musculoskeletal & Connective tissue Disorders	Back Pain	Nervous System Disorders	Dizziness	Headache	Somnolence	Tremor	Psychiatric Disorders	Anxiety	Insomnia	Major Depression	Renal & Urinary Disorders	Respiratory, Thoracic, & Mediastinal Disorders	Pharyngolaryngeal Pain	Sinus Congestion	Skin & Subcutaneous Tissue Disorders
4.5g SXB	20	7	0	4	0	2	1	1	3	0	0	4	0	0	2	1	8	3	2	0	0	4	1	2	1	0	2	0	0	1
4.5g SXB + 6 Tablets	21	6	0	3	1	4	0	2	5	1	2	0	3	0	3	0	5	1	3	0	0	5	1	3	0	2	2	1	0	1
6g SXB	21	5	1	2	1	5	0	1	2	1	0	0	3	3	3	2	9	4	2	1	0	5	0	0	2	0	2	0	0	3
6g SXB + 8 Tablets	23	11	2	7	2	6	3	1	3	2	0	0	1	1	3	2	10	2	3	2	2	11	2	3	0	0	5	2	2	3

Intervention	units on a scale (Mean)
	Baseline - pre treatment	Day 1 - post treatment
Spasmodic Dysphonia	24.0	20.0
Spasmodic Dysphonia/Voice Tremor	18.6	14.8

Intervention	voice breaks (Mean)
	Baseline - pre-treatment	Day 1 - post treatment
Spasmodic Dysphonia	3.6	2.6
Spasmodic Dysphonia/Voice Tremor	4.1	2.8

Intervention	percentage change from baseline (Mean)
	Limbic Striatum	Associative Striatum	Sensorimotor Striatum
Healthy Controls	-1.98	2.04	2.47
Narcolepsy With Cataplexy	2.00	6.10	6.51

Intervention	percentage change from baseline (Mean)
	Limbic Stiatum	Associative Striatum	Sensorimotor Striatum
Healthy Controls	6.49	2.11	1.93
Narcolepsy With Cataplexy	13.27	23.88	24.43

Intervention	BPND (Binding Potential) (Mean)
	Limbic Striatum	Associate Striatum	Sensorimotor Striatum
Healthy Controls	3.01	3.70	4.11
Narcolepsy With Cataplexy	2.94	3.80	3.87

Intervention	score on a scale (Median)
	Baseline	Final dose
Placebo (PBO) Arm	9.5	7.5
Sodium Oxybate (SXB) Arm	8.0	5.0

sodium oxybate

Description

Cross-References

Synonyms (82)

Research Excerpts

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Protein Targets (2)

Potency Measurements

Activation Measurements

Bioassays (46)

Research

Studies (1,684)

Market Indicators

Research Demand Index: 77.02

Study Types

Clinical Trials (37)

Trial Overview

Trial Outcomes

Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)

The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).

Adverse Experiences

Vital Signs

The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 3

The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Visit 4

The Total Thyroxin (T4) Measured in Fasting Conditions at Baseline (Visit 2)

The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 3

The Total Thyroxin (T4) Measured in Fasting Conditions at Visit 4

Cortisol Measured at Baseline (Visit 2)

Cortisol Measured at Visit 3

Cortisol Measured at Visit 4

Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Baseline (Visit 2)

Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 3

Electrolytes (Na, K, Ca) Measured in Fasting Conditions at Visit 4

The Circadian Rhythm of the Growth Hormone (GH) Measured at Baseline (Visit 2)

The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 3

The Circadian Rhythm of the Growth Hormone (GH) Measured at Visit 4

The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Baseline (Visit 2)

The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 3

The Adrenocorticotropic Hormone (ACTH) Measured in Fasting Conditions at Visit 4

The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Baseline (Visit 2)

The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 3

The Dehydroepiandrosterone Sulfate (DHEA-S) Measured in Fasting Conditions at Visit 4

The Electrolyte Phosphate (P) Measured in Fasting Conditions at Baseline (Visit 2)

The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 3

The Electrolyte Phosphate (P) Measured in Fasting Conditions at Visit 4

The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 1 Month of Treatment (Visit 3)

The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions After 3 Months of Treatment (Visit 4)

The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2)

The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study

The Number of Patients Reporting at Least One Adverse Event (AE) During the Course of the Study

The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study

The Osmolality Measured in Fasting Conditions at Baseline (Visit 2)

The Osmolality Measured in Fasting Conditions at Visit 3

The Osmolality Measured in Fasting Conditions at Visit 4

The Prolactin Measured in Fasting Conditions at Baseline (Visit 2)

The Prolactin Measured in Fasting Conditions at Visit 3

The Prolactin Measured in Fasting Conditions at Visit 4

The Thyroid Stimulating Hormone (TSH) Measured in Fasting Conditions at Baseline (Visit 2)

Assessment of Clinical Global Impression-change.

Assessment of Fatigue

Assessment of Insomnia Severity Index

Assessment of Pittsburgh Sleep Quality Index (PSQI)

Assessment of Sleepiness

Global Assessment of Change

Epworth Sleepiness Scale

MATRICS Neurocognitive Battery Composite

Pittsburgh Sleep Quality Index

Positive and Negative Syndrome Scale (PANSS) Negative Factor

Slow Wave Sleep Minutes

Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor

Polysomnography (PSG)

Sleep and Fatigue

Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects

Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase

Number of Participants Who Reported Positive Effects.

Breathlessness Severity