The use of sodium oxybate to treat narcolepsy

References

• Laborit G, Larcan A, Kind A. Electrocardiographic study of sodium 4-hydroxybutyrate. Agressologie4, 77–88 (1963).
   PubMedGoogle Scholar
• Broughton R, Mamelak M. Gamma-hydroxybutyrate in the treatment of compound narcolepsy: a preliminary report. In: Narcolepsy. Guilleminault C, Dement WC, Passouant P (Eds). Spectrum Publications, NY, USA, 1–35 (1976).
   Google Scholar
• Broughton R, Mamelak M. Effects of nocturnal gamma-hydoxybutyrate on sleep/waking patterns in narcolepsy–cataplexy. Can. J. Neurol. Sci.7, 23–31 (1980).
   PubMed Web of Science ®Google Scholar
• Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gammahydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep16, 216–220 (1993).
   PubMed Web of Science ®Google Scholar
• Scrima L, Hartman PG, Johnson FH Jr, Hiller FC. Efficacy of gamma-hydroxybutyrate versus placebo in treating narcolepsy–cataplexy: double-blind subjective measures. Biol. Psychiatry26, 331–343 (1989).
   PubMed Web of Science ®Google Scholar
• Scrima L, Hartman PG, Johnson FH. Jr, Thomas EE, Hiller FC. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep13, 479–490 (1990).
   PubMed Web of Science ®Google Scholar
• Nelson T, Kaufman E, Kline J, Sokoloff L. The extramural distribution of γ-hydroxybutyrate. J. Neurochem.37, 1345–1348 (1981).
   PubMedGoogle Scholar
• Okun MS, Boothby LA, Bartfield RB. GHB: an important pharmacological and clinical update. J. Pharm. Pharmaceut. Sci.4(2), 167–175 (2001).
   PubMed Web of Science ®Google Scholar
• Mamelak M. Gamma-hydroxybutyrate: an endogenous regulator of energy metabolism. Neurosci. Biobehav. Rev.13(4), 187–198 (1989).
   PubMed Web of Science ®Google Scholar
• Kaufmann EE, Porrino LJ, Nelson T. Pyretic action of low dose of gamma-hydroxy butyrate in rats. Biochem. Pharmacol.40, 2637–2240 (1990).
   PubMedGoogle Scholar
• Snead OC, Liu CC. Gamma-hydroxybutyric acid binding sites in rat and human brain synaptosomal membranes. Biochem. Pharmacol.33(16), 2587–2590 (1984).
   PubMed Web of Science ®Google Scholar
• Kaupmann K, Cryan JF, Wellendorph P et al. Specific gamma-hydroxybutyrate-binding sites but loss of pharmacological effects of gamma-hydroxybutyrate in GABA(B)(1)-deficient mice. Eur. J. Neurosci.18(10), 2722–2730 (2003).
   PubMedGoogle Scholar
• Vienne J, Bettler B, Franken P, Tafti M. Differential effects of GABAB receptor subtypes, (gamma)-hydroxybutyric acid, and baclofen on EEG activity and sleep regulation. J. Neurosci.30(42), 14194–14204 (2010).
   PubMed Web of Science ®Google Scholar
• Carai MAM, Colombo G, Brunetti G et al. Role of GABA(B) receptors in the sedative/hypnotic effect of γ-hydroxybutyric acid. Eur. J. Pharmacol.428(3), 315–321 (2001).
   PubMed Web of Science ®Google Scholar
• Pardi D, Black J. γ-hydroxybutyrate/sodium oxybate neurobiology, and impact on sleep and wakefulness. CNS Drugs20(12), 993–1018 (2006).
   PubMed Web of Science ®Google Scholar
• Van Cauter, Plat L, Scharf M et al. Simultaneous stimulation of slow-wave sleep and growth hormone secretion by gamma-hydroxybutyrate in normal young men. J. Clin. Invest.100(3), 745–753 (1997).
   PubMedGoogle Scholar
• Donjacour CE, Aziz NA, Roelfsma F et al. Effect of sodium oxybate on growth hormone secretion in narcolepsy patients and healthy controls. Am. J. Physiol. Endocrinol. Metab.300(6), E1069–E1075 (2011).
   PubMedGoogle Scholar
• Murphy KD, Rose MW, Chinkes DL et al. The effects of gammahydroxybutyrate on hypermetabolism and wound healing in a rat model of large thermal injury. J. Trauma63(5), 1099–1107 (2007).
   PubMedGoogle Scholar
• Gray JA, Goodwin GM, Heal DJ, Green AR. Hypothermia induced by baclofen, a possible index of GABAB receptor function in mice, is enhanced by antidepressant drugs and ECS. Br. J. Pharmacol.92, 863–870 (1987).
   PubMedGoogle Scholar
• García FB, Pedraza C, Arias JL, Navarro JF. Effects of subchronic administration of gammahydroxybutyrate (GHB) on spatial working memory in rats. Psicothema18(3), 519–524 (2006).
   PubMedGoogle Scholar
• Walsh JK, Hall-Porter JM, Griffin KS et al. Enhancing slow-wave sleep with sodium oxybate reduces the behavioral and physiological impact of sleep loss. Sleep33(9), 1217–1225 (2010).
   PubMedGoogle Scholar
• Pardi D, Black JE. Sodium oxybate: neurobiology and clinical efficacy. Future Neurol.1(6), 721–735 (2006).
   Google Scholar
• Borgen LA, Okerholm R, Morrison D, Lai A. The influence of gender and food on the pharmacokinetics of sodium oxybate oral solution in healthy subjects. J. Clin. Pharmacol.43, 59–65 (2003).
   PubMed Web of Science ®Google Scholar
• Snead OC, Gibson KM. γ-hydroxybutyric acid. N. Engl. J. Med.352, 2721–2732 (2005).
   PubMed Web of Science ®Google Scholar
• Borgen LA, Okerholm RA, Scharf MB. The pharmacokinetics of sodium oxybate following acute and chronic administration to narcoleptic patients. J. Clin. Pharmacol.44, 253–257 (2004).
   PubMed Web of Science ®Google Scholar
• Scharf MB, Lai AA, Branigan B, Stover R, Berkowitz DB. Pharmacokinetics of gamma-hydroxybutyrate (GHB) in narcoleptic patients. Sleep21, 507–514 (1998).
   PubMed Web of Science ®Google Scholar
• Borgen L, Lane E, Lai A. Xyrem (sodium oxybate). A study of dose proportionality in healthy human subjects. J. Clin. Pharmacol.40, 1053 (2000) (Abstract).
   Google Scholar
• US Xyrem Multicenter Study Group. 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. Sleep25(1), 42–49 (2002).
   PubMed Web of Science ®Google Scholar
• The Xyrem International Multicenter Study Group. A double-blind, placebo-controlled study demonstrates the nightly administration of sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J. Clin. Sleep Med.1, 391–397 (2005).
   PubMed Web of Science ®Google Scholar
• Xyrem International Study Group. Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients. Sleep Medicine6, 415–421 (2005).
   PubMed Web of Science ®Google Scholar
• US Xyrem Multicenter Study Group. A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep26, 31–35 (2003).
   PubMed Web of Science ®Google Scholar
• US Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med.5, 119–123 (2004).
   PubMed Web of Science ®Google Scholar
• Poryazova R, Tartarotti S, Khatami R et al. Sodium oxybate in narcolepsy with cataplexy: Zurich sleep center experience. Eur. Neurol.65(3), 175–182 (2011).
   PubMed Web of Science ®Google Scholar
• Mamelak M, Black J, Montplaisir J, Ristanovic R. A pilot study on the effects of sodium oxybate on sleep architecture and daytime alertness in narcolepsy. Sleep27(7), 1327–1334 (2004).
   PubMed Web of Science ®Google Scholar
• Black J, Houghton W. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep29(7), 939–946 (2006).
   PubMed Web of Science ®Google Scholar
• Black J, Pardi D, Hornfeldt CS, Inhaber N. The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption: a double-blind, placebo-controlled study in patients with narcolepsy. J. Clin. Sleep Med.6(6), 596–602 (2010).
   PubMed Web of Science ®Google Scholar
• Mamelak M, Escriu JM, Stokan O. The effects of gammahydroxybutyrate on sleep. Biol. Psychiatry12, 273–288 (1977).
   PubMed Web of Science ®Google Scholar
• Meerlo P, Westerveld P, Turek FW, Koehl M. Effects of gammahydroxybutyrate (GHB) on vigilance states and EEG in mice. Sleep27, 899–904 (2004).
   PubMedGoogle Scholar
• Dauvilliers Y, Paquereau J, Bastuji H, Drouot X, Weil JS, Viot-Blanc V. Psychological health in central hypersomnias: the French Harmony study. J. Neurol. Neurosurg. Psychiatry80(6), 636–641 (2009).
   PubMed Web of Science ®Google Scholar
• Schuld A, Hebebrand J, Geller F, Pollmacher T. Increased body-mass index in patients with narcolepsy. Lancet355, 1274–1275 (2000).
   PubMed Web of Science ®Google Scholar
• Droogleever Fortuyn HA, Swinkels S, Buitelaar J et al. High prevalence of eating disorders in narcolepsy with cataplexy: a case–control study. Sleep31(3), 335–341 (2008).
   PubMedGoogle Scholar
• Plazzi G, Ferri R, Antelmi E et al. Restless legs syndrome is frequent in narcolepsy with cataplexy patients. Sleep33(5), 689–694 (2010).
   PubMed Web of Science ®Google Scholar
• Mayer G, Meier-Ewert K. Motor dyscontrol in sleep of narcoleptic patients (a lifelong development?). J. Sleep Res.2, 143–148 (1993).
   PubMedGoogle Scholar
• Dauvilliers Y, Rompre S, Gagnon JF, Vendette M, Petit D, Montplaisir J. REM sleep characteristics in narcolepsy and REM sleep behavior disorder. Sleep30, 844–849 (2007).
   PubMedGoogle Scholar
• Knudsen S, Jennum PJ, Alving J, Sheikh SP, Gammeltoft S. Validation of the ICSD-2 criteria for CSF hypocretin-1 measurements in the diagnosis of narcolepsy in the Danish population. Sleep33(2), 169–176 (2010).
   PubMed Web of Science ®Google Scholar
• Sansa E, Iranzo A, Santamaria J. Obstructive sleep apnea in narcolepsy. Sleep Med.11(1), 93–95 (2010).
   PubMed Web of Science ®Google Scholar
• Abril B, Carlander B, Touchon J, Dauvilliers Y. Restless legs syndrome in narcolepsy: a side effect of sodium oxybate? Sleep Med.8(2), 181–183 (2007).
   PubMed Web of Science ®Google Scholar
• Mayer G, Kesper K, Dauvilliers Y, Sonka K, Black J. Muscle activity in sleep of narcoleptic patients treated with sodium oxybate. Presented at: The 25th Annual Meeting of the Associated Professional Sleep Socities (APSS). Minneapolis, MN, USA, 11–15 June 2011 (Abstract).
   Google Scholar
• Bosch OG, Quednow BB, Seifritz E, Wetter TC. Reconsidering GHB: orphan drug or new model antidepressant? J. Psychopharmacol. doi:10.1177/0269881111421975 (2011) (Epub ahead of print).
   PubMedGoogle Scholar
• Nightingale S, Orgill JC, Ebrahim IO, de Lacy SF, Agrawal S, Williams AJ. The association between narcolepsy and REM behavior disorder (RBD). Sleep Med.6, 253–258 (2005).
   PubMedGoogle Scholar
• Mattarozzi K, Bellucci C, Campi C et al. Clinical, behavioural and polysomnographic correlates of cataplexy in patients with narcolepsy/cataplexy. Sleep Med.9(4), 425–433 (2008).
   PubMedGoogle Scholar
• Ferri R, Franceschini C, Zucconi M et al. Searching for a marker of REM sleep behavior disorder: submentalis muscle EMG amplitude analysis during sleep in patients with narcolepsy/cataplexy. Sleep31(10), 1409–1417 (2008).
   PubMed Web of Science ®Google Scholar
• Husain AM, Ristanovic RK, Bogan RK. Weight loss in narcolepsy patients treated with sodium oxybate. Sleep Med.10(6), 661–663 (2008).
   PubMedGoogle Scholar
• Wang YG, Swick TJ, Carter LP, Thorpy MJ, Benowitz NL. Safety overview of postmarketing and clinical experience of sodium oxybate (Xyrem): abuse, misuse, dependence and diversion. J. Clin. Sleep Med.5(4), 365–371 (2009).
   PubMed Web of Science ®Google Scholar
• Weaver TE, Cuellar N. A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy. Sleep29(9), 1189–1194 (2006).
   PubMed Web of Science ®Google Scholar
• Murali H, Kotagal S. Off-label treatment of severe childhood narcolepsy–cataplexy with sodium oxybate. Sleep29, 1025–1029 (2006).
   PubMed Web of Science ®Google Scholar
• Aran A, Einen M, Lin L, Plazzi G, Nishino S, Mignot E. Clinical and therapeutic aspects of childhood narcolepsy–cataplexy: a retrospective study of 51 children. Sleep33(11), 1457–1464 (2010).
   PubMed Web of Science ®Google Scholar
• Carter LP, Pardi D, Gorsline J, Griffiths RR. Illicit gamma-hydroxybutyrate (GHB) and pharmaceutical sodium oxybate (Xyrem®): differences in characteristics and misuse. Drug Alcohol Depend.104(1–2), 1–10 (2009).
   PubMed Web of Science ®Google Scholar
• Ristanovic R, Black J, Mamelak M, Montplaisir J. Analysis of dose-effects of sodium oxybate on nocturnal respiratory disturbances. Sleep24(Suppl.), A473–A474 (2002).
   Google Scholar
• Black J, Ristanovic R, Mamelak M, Montplaisir J. Effect of increasing doses of sodium oxybate on nocturnal oxygen saturation: preliminary findings. Presented at: The 16th Annual Meeting of the Associated Professional Sleep Socities (APSS). Seattle, WA, USA, 10–14 June 2002.
   Google Scholar
• Donjacour CE, Aziz NA, Frölich M et al. Sodium oxybate increases prolactin secretion in narcolepsy patients and healthy controls. Eur. J. Endocrinol.164(3), 363–370 (2011).
   PubMedGoogle Scholar
• Seeck-Hirschner M, Baier P, von Freier A, Aldenhoff J, Göder R. Increase in sleep-related breathing disturbances after treatment with sodium oxybate in patients with narcolepsy and mild obstructive sleep apnea syndrome: two case reports. Sleep Med.10, 154–155 (2009).
   PubMedGoogle Scholar
• Poli F, Ricotta L, Vandi S et al. Catathrenia under sodium oxybate in narcolepsy with cataplexy. Sleep Breath.16(2), 427–434 (2012).
   PubMed Web of Science ®Google Scholar
• George CFP, Feldman N, Zheng Y et al. A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome. Sleep Breath.15, 13–20 (2011).
   PubMedGoogle Scholar
• Zvosec DL, Smith SW, Hall BJ. Three deaths associated with use of Xyrem. Sleep Med.10(4), 490–493 (2009).
   PubMed Web of Science ®Google Scholar
• Lammers GJ, Bassetti C, Billiard M et al. Sodium oxybate is an effective and safe treatment for narcolepsy. Sleep Med.11, 105–106 (2010).
   PubMedGoogle Scholar
• Feldman N. Clinical perspective: monitoring sodium oxybate treated narcolepsy patients for the development of sleep-disordered breathing. Sleep Breath.14, 77–79 (2010).
   PubMedGoogle Scholar
• Ferrara SD, Tedeschi L, Frison G, Rossi A. Fatality due to gammahydroxybutyric acid (GHB) and heroin intoxication. J. Forensic Sci.40, 501–504 (1995).
   PubMed Web of Science ®Google Scholar
• Billiard M, Bassetti C, Dauvilliers Y et al. EFNS guidelines on management of narcolepsy. Eur. J. Neurol.13(10), 1035–1048 (2006).
   PubMed Web of Science ®Google Scholar
• Morgenthaler TI, Kapur VK, Brown T et al. Standards of Practice Committee of the AASM. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin. Sleep30(12), 1705–1711 (2007).
   PubMed Web of Science ®Google Scholar
• Nimmerrichter AA, Walter H, Guiterrez-Lobos KE, Lesch OM. Double-blind controlled trial of gammahydroxybutyrate and chlormethiazole in the treatment of alcohol withdrawal. Alcohol Alcohol.37, 67–73 (2002).
   PubMed Web of Science ®Google Scholar
• Ameisen O. Gamma-hydroxybutyrate deficiency in alcohol-dependence? Alcohol Alcohol.42(5), 506 (2007).
   PubMedGoogle Scholar
• Russell J, Perkins AT, Michalek JE et al.; the Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum.60(1), 299–309 (2009).
   PubMed Web of Science ®Google Scholar
• Anderson KN, Shneerson JM. Drug treatment of REM sleep behavior disorder: the use of drug therapies other than clonazepam. J. Clin. Sleep Med.5(3), 235–239 (2009).
   PubMed Web of Science ®Google Scholar
• Khatami R, Tartarotti S, Siccoli MM, Bassetti CL, Sándor PS. Long-term efficacy of sodium oxybate in 4 patients with chronic cluster headache. Neurology77(1), 67–70 (2011).
   PubMedGoogle Scholar
• Ortega-Albás JJ, Díaz JR, López-Bernabé R, Vera JF, Alós M, Serrano AL. Treatment of Kleine–Levin syndrome with sodium oxybate. Sleep Med.12(7), 730 (2011).
   PubMedGoogle Scholar
• Lu J, Sherman D, Devor M, Saper C. A putative flip–flop switch for control of REM sleep. Nature441, 589–594 (2007).
   Google Scholar
• Zeitzer J, Buckmaster CL, Landolt H-P, Lyons D, Mignot E. Modafinil and γ-hydroxybutyrate have sleep state-specific pharmacological actions on hypocretin-1 physiology in a primate model of human sleep. Behav. Pharmacol.20(7), 643–652 (2009).
   PubMedGoogle Scholar
• Fronczek R, Raymann RJEM, Romeijn N et al. Manipulation of core body and skin temperature improves vigilance and maintenance of wakefulness in narcolepsy. Sleep31(2), 233–240 (2008).
   PubMed Web of Science ®Google Scholar