A review of sodium oxybate and baclofen in the treatment of sleep disorders

Current Pharmaceutical Design

Volumn 17, Issue 15, 2011, Pages 1430-1435

  Brown, Mark A ^a   Guilleminault, Christian ^a  

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Baclofen; Gaba b; Gamma hydroxybutyrate; Ghb; Insomnia; Narcolepsy; Sodium oxybate; Xyrem

Indexed keywords

4 AMINOBUTYRIC ACID B RECEPTOR; BACLOFEN; CLONAZEPAM; CLONIDINE; FOSPHENYTOIN SODIUM; GABAPENTIN; GAMMA BUTYROLACTONE; GROWTH HORMONE; MELATONIN; MODAFINIL; OXYBATE SODIUM; PLACEBO; TEMAZEPAM; TRIAZOLAM; ZOPICLONE;

AROUSAL; CATAPLEXY; CONFUSION; CONTROLLED CLINICAL TRIAL (TOPIC); DAYTIME SOMNOLENCE; DIZZINESS; DOSE RESPONSE; DRUG BINDING SITE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG MECHANISM; DRUG RECEPTOR BINDING; ELECTROENCEPHALOGRAPHY; ENURESIS; EVENING DOSAGE; FATAL FAMILIAL INSOMNIA; FIBROMYALGIA; HEADACHE; HORMONE RELEASE; HUMAN; INSOMNIA; LATENT PERIOD; LOADING DRUG DOSE; LOW DRUG DOSE; MULTICENTER STUDY (TOPIC); NARCOLEPSY; NAUSEA; NIGHT SLEEP; PAIN; PARASOMNIA; PERIODIC LIMB MOVEMENT DISORDER; POLYSOMNOGRAPHY; PRIORITY JOURNAL; PSYCHOMOTOR ACTIVITY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REM SLEEP; REVIEW; SCHIZOPHRENIA; SEDATION; SEIZURE; SLEEP DEPRIVATION; SLEEP DISORDER; SLEEP DISORDERED BREATHING; SLEEP PARAMETERS; SLEEP TIME; SLOW WAVE SLEEP; SOMNOLENCE; VIRUS INFECTION; VOMITING;

ANIMALS; BACLOFEN; GABA-B RECEPTOR AGONISTS; HUMANS; NARCOLEPSY; SLEEP; SLEEP DISORDERS; SLEEP INITIATION AND MAINTENANCE DISORDERS; SODIUM OXYBATE;

EID: 84863393404     PISSN: 13816128     EISSN: 18734286     Source Type: Journal    
DOI: 10.2174/138161211796197098     Document Type: Review

References (67)

1. Mott DD, Lewis DV. The pharmacology and function of central GABAB receptors. Int Rev Neurobiol 1994; 36: 97-223.
2. Juhasz G, Emri Z, Kekesi KA, Salfay O, Crunelli V. Blockade of thalamic GABAB receptors decreases EEG synchronization. Neurosci Lett 1994; 172: 155-58.
3. Ulloor J, Mavanji V, Saha S, Siwek DF, Datta S. Spontaneous REM sleep is modulated by the activation of the pedunculopontine tegmental GABAB receptors in the freely moving rat. J Neurophysiol 2004; 91: 1822-31.
4. 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 2010; 30: 14194-204.
5. Manfridi A, Brambilla D, Mancia M. Sleep is differently modulated by basal forebrain GABA(A) and GABA(B) receptors. Am J Physiol Regul Integr Comp Physiol 2001; 281: R170-5.
6. Roth RH, Giarman NJ. Conversion in vivo of gamma-aminobutyric to gamma-hydroxybutyric acid in the rat. Biochem Pharmacol 1969; 18: 247-50.
7. Snead OC, 3rd, Furner R, Liu CC. In vivo conversion of gammaaminobutyric acid and 1,4-butanediol to gamma-hydroxybutyric acid in rat brain. Studies using stable isotopes. Biochem Pharmacol 1989; 38: 4375-80.
8. Roth RH, Giarman NJ. Preliminary report on the metabolism of gamma-butyrolactone and gamma-hydroxybutyric acid. Biochem Pharmacol 1965; 14: 177-8.
9. Roth RH, Levy R, Giarman NJ. Dependence of rat serum lactonase upon calcium. Biochem Pharmacol 1967; 16: 596-8.
10. Bessman SP, Fishbein WN. Gamma-hydroxybutyrate, a normal brain metabolite. Nature 1963; 200: 1207-8.
11. Cash CD, Maitre M, Mandel P. Purification from human brain and some properties of two NADPH-linked aldehyde reductases which reduce succinic semialdehyde to 4-hydroxybutyrate. J Neurochem 1979; 33: 1169-75.
12. Snead OC, 3rd, Liu CC. Gamma-hydroxybutyric acid binding sites in rat and human brain synaptosomal membranes. Biochem Pharmacol 1984; 33: 2587-90.
13. Snead OC, 3rd Evidence for a G protein-coupled gammahydroxybutyric acid receptor. J Neurochem 2000; 75: 1986-96.
14. Andriamampandry C, Taleb O, Kemmel V, Humbert JP, Aunis D, Maitre M. Cloning and functional characterization of a gammahydroxybutyrate receptor identified in the human brain. FASEB J 2007; 21: 885-95.
15. Kemmel V, Taleb O, Perard A, et al. Neurochemical and electrophysiological evidence for the existence of a functional gammahydroxybutyrate system in NCB-20 neurons. Neuroscience 1998; 86: 989-1000.
16. Mathivet P, Bernasconi R, De Barry J, Marescaux C, Bittiger H. Binding characteristics of gamma-hydroxybutyric acid as a weak but selective GABAB receptor agonist. Eur J Pharmacol 1997; 321: 67-75.
17. Lingenhoehl K, Brom R, Heid J, et al. Gamma-hydroxybutyrate is a weak agonist at recombinant GABA(B) receptors. Neuropharmacology 1999; 38: 1667-73.
18. Doherty JD, Hattox SE, Snead OC, Roth, RH. Identification of endogenous gamma-hydroxybutyrate in human and bovine brain and its regional distribution in human, guinea pig and rhesus monkey brain. J Pharmacol Exp Ther 1978; 207: 130-9.
19. 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. Sleep 2002; 25: 42-9.
20. Kaupmann K, Cryan JF, Wellendorph P, et al. Specific gammahydroxybutyrate- binding sites but loss of pharmacological effects of gamma-hydroxybutyrate in GABA(B)(1)-deficient mice. Eur J Neurosci 2003; 18: 2722-30.
21. Nasrallah FA, Maher AD, Hanrahan JR, Balcar VJ, Rae CD. Gamma-Hydroxybutyrate and the GABAergic footprint: a metabolomic approach to unpicking the actions of GHB. J Neurochem 2010; 115: 58-67.
22. Laborit H. Sodium 4-Hydroxybutyrate. Int J Neuropharmacol 1964; 3: 433-51.
23. Metcalf DR, Emde RN, Stripe JT. An EEG-behavioral study of sodium hydroxybutyrate in humans. Electroencephalogr Clin Neurophysiol 1966; 20: 506-12.
24. Blumenfeld M, Suntay RG, Harmel MH. Sodium gammahydroxybutyric acid: a new anaesthetic adjuvant. Anesth Analg 1962; 41: 721-6.
25. Mamelak M, Escriu JM, Stokan O. Sleep-inducing effects of gammahydroxybutyrate. Lancet 1973; 2: 328-9.
26. Reder AT, Mednick AS, Brown P, et al. Clinical and genetic studies of fatal familial insomnia. Neurology 1995; 45: 1068-75.
27. 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. Sleep 2010; 33: 1217-25.
28. Scharf MB, Hauck M, Stover R, McDannold M, Berkowitz D. Effect of gamma-hydroxybutyrate on pain, fatigue, and the alpha sleep anomaly in patients with fibromyalgia. Preliminary report. J Rheumatol 1998; 25: 1986-90.
29. Scharf MB, Baumann M, Berkowitz DV. The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. J Rheumatol 2003; 30: 1070-4.
30. Russell IJ, Perkins AT, Michalek JE, Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, doubleblind, placebo-controlled, multicenter clinical trial. Arthritis Rheum 2009; 60: 299-309.
31. Kantrowitz JT, Oakman E, Bickel S, et al. The importance of a good night's sleep: an open-label trial of the sodium salt of gammahydroxybutyric acid in insomnia associated with schizophrenia. Schizophr Res 2010; 120: 225-6.
32. Yamada Y, Yamamoto J, Fujiki A, et al. Effect of butyrolactone and gamma-hydroxybutyrate on the EEG and sleep cycle in man. Electroencephalogr Clin Neurophysiol 1967; 22: 558-62.
33. Lapierre O, Montplaisir J, Lamarre M, Bedard MA. The effect of gamma-hydroxybutyrate on nocturnal and diurnal sleep of normal subjects: further considerations on REM sleep-triggering mechanisms. Sleep 1990; 13: 24-30.
34. Van Cauter E, Plat L, Scharf MB, et al. Simultaneous stimulation of slow-wave sleep and growth hormone secretion by gammahydroxybutyrate in normal young men. J Clin Invest 1997; 100: 745-53.
35. Sassin JF, Parker DC, Mace JW, et al. Human growth hormone release: relation to slow-wave sleep and sleep-walking cycles. Science 1969; 165: 513-5.
36. Carter LP, Griffiths RR, Mintzer MZ. Cognitive, psychomotor, and subjective effects of sodium oxybate and triazolam in healthy volunteers. Psychopharmacology 2009; 206: 141-54.
37. Oliveto A, Gentry WB, Pruzinsky R, et al. Behavioral effects of gamma-hydroxybutyrate in humans. Behav Pharmacol 2010; 21: 332-42.
38. Mamelak M, Escriu JM, Stokan O. The effects of gammahydroxybutyrate on sleep. Biol Psychiatry 1977; 12: 273-88.
39. Broughton R, Mamelak M. The treatment of narcolepsy-cataplexy with nocturnal gamma-hydroxybutyrate. Can J Neurol Sci 1979; 6: 1-6.
40. Broughton R, Mamelak M. Effects of nocturnal gammahydroxybutyrate on sleep/waking patterns in narcolepsy-cataplexy. Can J Neurol Sci 1980; 7: 23-31.
41. Scharf MB, Brown D, Woods M, Brown L, Hirschowitz J. The effects and effectiveness of gamma-hydroxybutyrate in patients with narcolepsy. J Clin Psychiatry 1985; 46: 222-5.
42. Scrima L, Hartman PG, Johnson FH, Jr, Hiller FC. Efficacy of gamma-hydroxybutyrate versus placebo in treating narcolepsycataplexy: double-blind subjective measures. Biol Psychiatry 1989; 26: 331-43.
43. 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. Sleep 1990; 13: 479-90.
44. Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gamma-hydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep 1993; 16: 216-20.
45. A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep 2003; 26: 31-5.
46. U.S. Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med 2004; 5: 119-23.
47. Xyrem International Study Group. Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a doubleblind, placebo-controlled study in 228 patients. Sleep Med 2005; 6: 415-21.
48. 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. Sleep 2004; 27: 1327-34.
49. Xyrem International Study Group. A double-blind, placebocontrolled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J Clin Sleep Med 2005; 1: 391-7.
50. Weaver TE, Cuellar N. A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy. Sleep 2006; 29: 1189-94.
51. Challamel MJ, Mazzola ME, Nevsimalova S, Cannard C, Louis J, Revol M. Narcolepsy in children. Sleep 1994; 17: S17-20.
52. Murali H, Kotagal S. Off-label treatment of severe childhood narcolepsy- cataplexy with sodium oxybate. Sleep 2006; 29: 1025-9.
53. Black J, Houghton WC. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep 2006; 29: 939-46.
54. Black J, Pardi D, Hornfeldt CS, Inhaber N. The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy. Sleep Med 2009; 10: 829-35.
55. Moldofsky H, Scarisbrick P, England R, Smythe H. Musculosketal symptoms and non-REM sleep disturbance in patients with fibrositis syndrome and healthy subjects. Psychosom Med 1975; 37: 341-51.
56. Kantrowitz J, Citrome L, Javitt D. GABA(B) receptors, schizophrenia and sleep dysfunction: a review of the relationship and its potential clinical and therapeutic implications. CNS Drugs 2009; 23: 681-91.
57. Shneerson JM. Successful treatment of REM sleep behavior disorder with sodium oxybate. Clin Neuropharmacol 2009; 32: 158-9.
58. Kothare SV, Adams R, Valencia I, Faerber EC, Grant ML. Improved sleep and neurocognitive functions in a child with thalamic lesions on sodium oxybate. Neurology 2007; 68: 1157-8.
59. Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J 1971; 4: 15-7.
60. Sachais BA, Logue JN, Carey MS. Baclofen, a new antispastic drug. A controlled, multicenter trial in patients with multiple sclerosis. Arch Neurol 1977; 34: 422-8.
61. Schweitzer P, Roberto M, Madamba SG, Siggins GR. Gammahydroxybutyrate increases a potassium current and decreases the Hcurrent in hippocampal neurons via GABAB receptors. J Pharmacol Exp Ther 2004; 311: 172-9.
62. Cui R, Li B, Suemaru K, Araki H. The effect of baclofen on alterations in the sleep patterns induced by different stressors in rats. J Pharmacol Sci 2009; 109: 518-24.
63. van Nieuwenhuijzen PS, McGregor IS, Hunt GE. The distribution of gamma-hydroxybutyrate-induced Fos expression in rat brain: comparison with baclofen. Neuroscience 2009; 158: 441-55.
64. Guilleminault C, Flagg W. Effect of baclofen on sleep-related periodic leg movements. Ann Neurol 1984; 15: 234-9.
65. Finnimore AJ, Roebuck M, Sajkov D, McEvoy RD. The effects of the GABA agonist, baclofen, on sleep and breathing. Eur Respir J 1995; 8: 230-4.
66. Darbari FP, Melvin JJ, Piatt JH, Jr, Adirim TA, Kothare SV. Intrathecal baclofen overdose followed by withdrawal: clinical and EEG features. Pediatr Neurol 2005; 33: 373-7.
67. Huang YS, Guilleminault C. Narcolepsy: action of two gammaaminobutyric acid type B agonists, baclofen and sodium oxybate. Pediatr Neurol 2009; 41: 9-16.