A review of tolerability and abuse liability of γ-hydroxybutyric acid for insomnia in patients with schizophrenia

Clinical Therapeutics

Volumn 31, Issue SUPPL. 1, 2009, Pages 1360-1373

  Kantrowitz, Joshua T ^a,b   Citrome, Leslie ^a,b   Javitt, Daniel C ^a,b  

^a NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

^b NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

abuse liability; GHB; insomnia; narcolepsy; schizophrenia; tolerability

Indexed keywords

1,4 BUTANEDIOL; 4 HYDROXYBUTYRIC ACID; ALCOHOL; DIAZEPAM; FLUNITRAZEPAM; GAMMA BUTYROLACTONE; ILLICIT DRUG; LORAZEPAM; OXYBATE SODIUM; PLACEBO;

ALCOHOL WITHDRAWAL; ALCOHOLISM; ANXIETY DISORDER; AUTOPSY; CLINICAL TRIAL; COMA; CONFUSION; CONTROLLED CLINICAL TRIAL; DELIRIUM; DIZZINESS; DRUG ABUSE; DRUG DEPENDENCE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG HALF LIFE; DRUG OVERDOSE; DRUG POTENTIATION; DRUG TOLERABILITY; ENURESIS; EUPHORIA; FATIGUE; GLASGOW COMA SCALE; HALLUCINATION; HUMAN; HYPERTENSION; HYPOTENSION; INSOMNIA; LEGAL LIABILITY; MORTALITY; MOTOR DYSFUNCTION; NARCOLEPSY; NAUSEA; RANDOMIZED CONTROLLED TRIAL; RAPE; REVIEW; RHABDOMYOLYSIS; RISK BENEFIT ANALYSIS; SCHIZOPHRENIA; SEDATION; SEIZURE; SEXUAL AROUSAL; SEXUAL BEHAVIOR; SIDE EFFECT; SLEEP WALKING; SOMNOLENCE; TACHYCARDIA; TREMOR; VOMITING; WITHDRAWAL SYNDROME;

HUMANS; HYDROXYBUTYRATES; SCHIZOPHRENIA; SLEEP INITIATION AND MAINTENANCE DISORDERS;

EID: 68749095941     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.07.005     Document Type: Review

References (93)

1. Xyrem (sodium oxybate) oral solution (2008), Jazz Pharmaceuticals Inc, Palo Alto, Calif. http://www.xyrem.com/xyrem-pi.pdf Accessed December 26, 2008
2. Morgenthaler T.I., Kapur V.K., Brown T., et al., Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin [published correction appears in Sleep. 2008;31:table of contents]. Sleep 30 (2007) 1705-1711
3. Billiard M., Bassetti C., Dauvilliers Y., et al., EFNS Task Force. EFNS guidelines on management of narcolepsy. Eur J Neurol. 13 (2006) 1035-1048
4. Castelli M.P. Multi-faceted aspects of gamma-hydroxybutyric acid: A neurotransmitter, therapeutic agent and drug of abuse. Mini Rev Med Chem. 8 (2008) 1188-1202
5. Kraepelin E. Dementia Praecox and Paraphrenia (1919), E. & S. Livingstone, Edinburgh, Scotland
6. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (2000), American Psychiatric Association, Washington, DC
7. Kantrowitz JT, Citrome L, Javitt DC. GABAB receptors, schizophrenia and sleep dysfunction: A review of the relationship and its clinical and therapeutic implications. CNS Drugs. In press.
8. Balla A., Nattini M.E., Sershen H., et al. GABAB/NMDA receptor interaction in the regulation of extracellular do-pamine levels in rodent prefrontal cortex and striatum. Neuropharmacology 56 (2009) 915-921
9. Porrata T. G'd Up 24/7: The GHB Addiction Guide (2007), Law Tech Publishing
10. Yang H.W., Simoni-Wastila L., Zuckerman I.H., and Stuart B. Benzodiazepine use and expenditures for Medicare beneficiaries and the implications of Medicare Part D exclusions. Psychiatr Serv. 59 (2008) 384-391
11. Anon. 'Date-rape' drug linked to a death, 69 poisonings. Wall Street Journal (April 4, 1997) Sect. B6
12. National Institute on Drug Abuse (NIDA). NIDA InfoFacts: Club Drugs (GHB, Ketamine, and Rohypnol) [NIDA Web site]. http://www.dmga-buse.gov/InfoFacts/clubdrugs.html
13. Green A.I., Drake R.E., Brunette M.F., and Noordsy D.L. Schizophrenia and cooccurring substance use disorder. Am J Psychiatry 164 (2007) 402-408
14. Tanaka Z., Mukai A., Takayanagi Y., et al. Clinical application of 4-hydroxy-butyrate sodium and 4-butyrolactone in neuropsychiatric patients. Folia Psychiatric Neurol Jpn. 20 (1966) 9-17
15. Levy M.I., Davis B.M., Mohs R.C., et al. Gamma-hydroxybutyrate in the treatment of schizophrenia. Psychiatry Res. 9 (1983) 1-8
16. Schulz S.C., van Kammen D.P., Buchsbaum M.S., et al. Gamma-hydroxybutyrate treatment of schizophrenia: A pilot study. Pharmacopsychiatria 14 (1981) 129-134
17. Sodium oxybate in schizophrenia with insomnia [ClinicalTrials.gov Identifier: NCT00594256]. http://www.clinicaltrials.gov/ct2/show/NCT00594256 Accessed December 26, 2008
18. Kantrowitz J.T., Oakman E., Bickel S., et al. Open label, pilot study of adjunctive Xyrem (sodium oxybate) for the treatment of schizophrenia and associated sleep disturbances. Presented at: 12th International Congress of Schizophrenia Research. San Diego, Calif. (March, 27-28, 2009)
19. Lemon M.D., Strain J.D., and Farver D.K. Sodium oxybate for cataplexy. Ann Pharmacother. 40 (2006) 433-440 quiz
20. Lemon M.D., Strain J.D., and Farver D.K. Sodium oxybate for cataplexy. Ann Pharmacother. 40 (2006) 581-582
21. 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 25 (2002) 42-49
22. A 1 2-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep 26 (2003) 31-35
23. A double-blind, placebo-controlled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J Clin Sleep Med. 1 (2005) 391-397
24. Hudgel D.W. Problems with latest Xyrem group investigation. J Clin Sleep Med. 2 (2006) 96 author reply
25. Hudgel D.W. Problems with latest Xyrem group investigation. J Clin Sleep Med. 2 (2006) 97
26. Scharf M.B., Baumann M., and Berkowitz D.V. The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. J Rheumatol. 30 (2003) 1070-1074
27. Ondo W.G., Perkins T., Swick T., et al. Sodium oxybate for excessive daytime sleepiness in Parkinson disease: An open-label polysomnographic study. Arch Neurol. 65 (2008) 1337-1340
28. Moncini M., Masini E., Gambassi F., and Mannaioni P.F. Gamma-hydroxybutyric acid and alcohol-related syndromes. Alcohol 20 (2000) 285-291
29. Nimmerrichter A.A., Walter H., Gutierrez-Lobos K.E., and Lesch O.M. Double-blind controlled trial of gamma-hydroxybutyrate and clomethiazole in the treatment of alcohol withdrawal. Alcohol Alcohol 37 (2002) 67-73
30. Addolorato G., Castelli E., Stefanini G.F., et al., GHB Study Group. An open multicentric study evaluating 4-hydroxybutyric acid sodium salt in the medium-term treatment of 179 alcohol dependent subjects. Alcohol Alcohol 31 (1996) 341-345
31. Caputo F., Addolorato G., Lorenzini F., et al. Gamma-hydroxybutyric acid versus naltrexone in maintaining alcohol abstinence: An open randomized comparative study. Drug Alcohol Depend. 70 (2003) 85-91
32. Gallimberti L., Spella M.R., Soncini C.A., and Gessa G.L. Gamma-hydroxybutyric acid in the treatment of alcohol and heroin dependence. Alcohol 20 (2000) 257-262
33. Owen R.T. Sodium oxybate: Efficacy, safety and tolerability in the treatment of narcolepsy with or without cataplexy. Drugs Today (Barc). 44 (2008) 197-204
34. Wedin G.P., Hornfeldt C.S., and Ylitalo L.M. The clinical development of gamma-hydroxybutyrate (GHB). Curr Drug Saf. 1 (2006) 99-106
35. Anderson I.B., Kim-Katz S.Y., Dyer J.E., et al. Area-level socioeconomic status in relation to outcomes in gamma-hydroxybutyrate intoxication. Clin Toxicol (Phila). 47 (2008) 48-57
36. Kim S.Y., Anderson I.B., Dyer J.E., et al. High-risk behaviors and hospitalizations among gamma hydroxybutyrate (GHB) users. Am J Drug Alcohol Abuse 33 (2007) 429-438
37. Chin M.Y., Kreutzer R.A., and Dyer J.E. Acute poisoning from gamma-hydroxybutyrate in California. West J Med. 156 (1992) 380-384
38. Chin R.L., Sporer K.A., Cullison B., et al. Clinical course of gamma-hydroxybutyrate overdose. Ann Emerg Med. 31 (1998) 716-722
39. Gonzalez A., and Nutt D.J. Gamma hydroxy butyrate abuse and dependency. J Psychopharmacol. 19 (2005) 195-204
40. Teasdale G., and Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet 2 (1974) 81-84
41. Miró O., Nogué S., Espinosa G., et al. Trends in illicit drug emergencies: The emerging role of gamma-hydroxybutyrate. J Toxicol Clin Toxicol. 40 (2002) 129-135
42. Liechti M.E., Kunz I., Greminger P., et al. Clinical features of gamma-hydroxybutyrate and gamma-butyrolactone toxicity and concomitant drug and alcohol use. Drug Alcohol Depend. 81 (2006) 323-326
43. Knudsen K., Greter J., and Verdicchio M. High mortality rates among GHB abusers in Western Sweden. Clin Toxicol (Phila). 46 (2008) 187-192
44. Van Sassenbroeck D.K., De Neve N., De Paepe P., et al. Abrupt awakening phenomenon associated with gamma-hydroxybutyrate use: A case series. Clin Toxicol (Phila). 45 (2007) 533-538
45. Wojtowicz J.M., Yarema M.C., and Wax P.M. Withdrawal from gamma-hydroxybutyrate, 1,4-butanediol and gamma-butyrolactone: A case report and systematic review. CJEM. 10 (2008) 69-74
46. Timby N., Eriksson A., and Boström K. Gamma-hydroxybutyrate associated deaths. Am J Med. 108 (2000) 518-519
47. Bosman I.J., and Lusthof K.J. Forensic cases involving the use of GHB in the Netherlands. Forensic Sci Int. 133 (2003) 17-21
48. Caldicott D.G., Chow F.Y., Burns B.J., et al. Fatalities associated with the use of gamma-hydroxybutyrate and its analogues in Australasia. Med J Aust. 181 (2004) 310-313
49. Jones A.W., Holmgren A., and Kugelberg F.C. Gamma-hydroxybutyrate concentrations in the blood of impaired drivers, users of illicit drugs, and medical examiner cases. J Anal Toxicol. 31 (2007) 566-572
50. Lenz D., Rothschild M.A., and Kröner L. Intoxications due to ingestion of gamma-butyrolactone: Organ distribution of gamma-hydroxybutyric acid and gamma-butyrolactone. Ther Drug Monit. 30 (2008) 755-761
51. Abanades S., Farré M., Segura M., et al. Disposition of gamma-hydroxybutyric acid in conventional and nonconventional biologic fluids after single drug administration: Issues in methodology and drug monitoring. Ther Drug Monit. 29 (2007) 64-70
52. Luby S., Jones J., and Zalewski A. GHB use in South Carolina. Am J Public Health. 82 (1992) 128
53. Centers for Disease Control. Multistate outbreak of poisonings associated with illicit use of gamma hy-droxy butyrate. MMWR Morb Mortal Wkly Rep. 39 (1990) 861-863
54. Centers for Disease Control. Epidemiologic notes and reports multistate outbreak of poisonings associated with illicit use of gamma hydroxy butyrate. Morbidity and Mortality Weekly Report (November 8, 1990). http://www.cdc.gov/mmwr/preview/mmwrhtml/00001847.htm Accessed June 15, 2009
55. Sumnall H.R., Woolfall K., Edwards S., et al. Use, function, and subjective experiences of gamma-hydroxybutyrate (GHB). Drug Alcohol Depend. 92 (2008) 286-290
56. Galloway G.P., Frederick-Osborne S.L., Seymour R., et al. Abuse and therapeutic potential of gamma-hydroxybutyric acid. Alcohol. 20 (2000) 263-269
57. Lee S.J., and Levounis P. Gamma hydroxybutyrate: An ethnographic study of recreational use and abuse. J Psychoactive Drugs. 40 (2008) 245-253
58. Barrett S.P., Gross S.R., Garand I., and Pihl R.O. Patterns of simultaneous polysubstance use in Canadian rave attendees. Subst Use Misuse. 40 (2005) 1525-1537
59. Halkitis P.N., and Palamar J.J. GHB use among gay and bisexual men. Addict Behav. 31 (2006) 2135-2139
60. ElSohly M.A., and Salamone S.J. Prevalence of drugs used in cases of alleged sexual assault. J Anal Toxicol. 23 (1999) 141-146
61. Scott-Ham M., and Burton F.C. Toxicological findings in cases of alleged drug-facilitated sexual assault in the United Kingdom over a 3-year period. J Clin Forensic Med. 12 (2005) 175-186
62. Beynon C.M., McVeigh C., McVeigh J., et al. The involvement of drugs and alcohol in drug-facilitated sexual assault: A systematic review of the evidence. Trauma Violence Abuse. 9 (2008) 178-188
63. LeBeau M.A., Montgomery M.A., Morris-Kukoski C., et al. A comprehensive study on the variations in urinary concentrations of endogenous gamma-hydroxybutyrate (GHB). J Anal Toxicol. 30 (2006) 98-105
64. Anderson I.B., Kim S.Y., Dyer J.E., et al. Trends in gamma-hydroxybutyrate (GHB) and related drug intoxication: 1999 to 2003. Ann Emerg Med. 47 (2006) 177-183
65. Wood D.M., Warren-Gash C., Ashraf T., et al. Medical and legal confusion surrounding gamma-hydroxybutyrate (GHB) and its precursors gamma-butyrolactone (GBL) and 1,4-butanediol (1,4BD). QJM. 101 (2008) 23-29
66. Dietze P.M., Cvetkovski S., Barratt M.J., and Clemens S. Patterns and incidence of gamma-hydroxybutyrate (GHB)-related ambulance attendances in Melbourne, Victoria. Med J Aust. 188 (2008) 709-711
67. Degenhardt L., and Dunn M. The epidemiology of GHB and ketamine use in an Australian household survey. Int J Drug Policy 19 (2008) 311-316
68. Griffiths R.R., Bigelow G.E., and Ator N.A. Principles of initial experimental drug abuse liability assessment in humans. Drug Alcohol Depend. 70 Suppl (2003) S41-S54
69. Nicholson K.L., and Balster R.L. GHB: A new and novel drug of abuse. Drug Alcohol Depend. 63 (2001) 1-22
70. Baker L.E., Searcy G.D., Pynnonen D.M., and Poling A. Differentiating the discriminative stimulus effects of gamma-hydroxybutyrate and ethanol in a three-choice drug discrimination procedure in rats. Pharmacol Biochem Behav. 89 (2008) 598-607
71. Beardsley P.M., Balster R.L., and Harris L.S. Evaluation of the discriminative stimulus and reinforcing effects of gamma-hydroxybutyrate (GHB). Psychopharmacolology (Berl). 127 (1996) 315-322
72. Woolverton W.L., Rowlett J.K., Winger G., et al. Evaluation of the reinforcing and discriminative stimulus effects of gamma-hydroxybutyrate in rhesus monkeys. Drug Alcohol Depend. 54 (1999) 137-143
73. McMahon L.R., Coop A., France C.P., et al. Evaluation of the reinforcing and discriminative stimulus effects of 1,4-butanediol and gamma-butyrolactone in rhesus monkeys. Eur J Pharmacol. 466 (2003) 113-120
74. Helms C.M., Rogers L.S., and Grant K.A. Gamma-hydroxybutyric acid in male and female cynomolgus monkeys trained to discriminate 1.0 or 2.0 g/kg ethanol. Behav Pharmacol. 19 (2008) 317-324
75. Winger G., Galuska C.M., and Hursh S.R. Modification of ethanol's reinforcing effectiveness in rhesus monkeys by cocaine, flunitrazepam, or gamma-hydroxybutyrate. Psychopharmacology (Berl). 193 (2007) 587-598
76. Abanades S., Farré M., Barral D., et al. Relative abuse liability of gamma-hydroxybutyric acid, flunitrazepam, and ethanol in club drug users. J Clin Psychopharmacol. 27 (2007) 625-638
77. Rosen M.I., Pearsall H.R., Woods S.W., and Kosten T.R. Effects of gamma-hydroxybutyric acid (GHB) in opioid-dependent patients. J Subst Abuse Treat. 14 (1997) 149-154
78. Carter L.P., Richards B.D., Mintzer M.Z., and Griffiths R.R. Relative abuse liability of GHB in humans: A comparison of psychomotor, subjective, and cognitive effects of supratherapeutic doses of triazolam, pentobarbital, and GHB. Neuropsychopharmacology. 31 (2006) 2537-2551
79. Grove-White I.G., and Kelman G.R. Effect of methohexitone, diazepam and sodium 4-hydroxybutyrate on short-term memory. Br J Anaesth. 43 (1971) 113-116
80. Mattila M.J., Palva E., Seppälä T., and Ostrovskaya R.U. Actions and interactions with alcohol of drugs on psychomotor skills: Comparison of diazepam and gamma-hydroxybutyric acid. Arch Int Pharmacodyn Ther. 234 (1978) 236-246
81. Ferrara S.D., Giorgetti R., Zancaner S., et al. Effects of single dose of gamma-hydroxybutyric acid and lorazepam on psychomotor performance and subjective feelings in healthy volunteers. Eur J Clin Pharmacol. 54 (1999) 821-827
82. Griffiths R.R., and Johnson M.W. Relative abuse liability of hypnotic drugs: A conceptual framework and algorithm for differentiating among compounds. J Clin Psychiatry. 66 Suppl 9 (2005) 31-41
83. Mamelak M., Scharf M.B., and Woods M. Treatment of narcolepsy with gamma-hydroxybutyrate. A review of clinical and sleep laboratory findings. Sleep. 9 (1986) 285-289
84. Scrima L., Hartman P.G., Johnson Jr. F.H., and Hiller F.C. Efficacy of gamma-hydroxybutyrate versus placebo in treating narcolepsy-cataplexy: Doubleblind subjective measures. Biol Psychiatry. 26 (1989) 331-343
85. Mamelak M., Black J., Montplaisir J., and Ristanovic R. A pilot study on the effects of sodium oxybate on sleep architecture and daytime alertness in narcolepsy. Sleep. 27 (2004) 1327-1334
86. Lammers G.J., Arends J., Declerck A.C., et al. Gammahydroxybutyrate and narcolepsy: A double-blind placebo-controlled study. Sleep. 16 (1993) 216-220
87. The abrupt cessation of therapeutically administered sodium oxybate (GHB) does not cause withdrawal symptoms. J Toxicol Clin Toxicol. 41 (2003) 131-135
88. Dyken M.E., and Yamada T. Narcolepsy and disorders of excessive somnolence. Prim Care. 32 (2005) 389-413
89. Beghè F., and Carpanini M.T. Safety and tolerability of gamma-hydroxybutyric acid in the treatment of alcohol-dependent patients. Alcohol. 20 (2000) 223-225
90. Addolorato G., Caputo F., Capristo E., et al. A case of gamma-hydroxybutyric acid withdrawal syndrome during alcohol addiction treatment: Utility of diazepam administration. Clin Neuropharmacol. 22 (1999) 60-62
91. Caputo F, Francini S, Stoppo M, et al. Incidence of craving for and abuse of gamma-hydroxybutyric acid (GHB) in different populations of treated alcoholics: An open comparative study [published online ahead of print July 17, 2008]. J Psychopharmacol.
92. Green A.I., Drake R.E., Brunette M.F., and Noordsy D.L. Schizophrenia and co-occurring substance use disorder. Am J Psychiatry. 164 (2007) 402-408
93. Thai D., Dyer J.E., Benowitz N.L., and Haller C.A. Gamma-hydroxybutyrate and ethanol effects and interactions in humans. J Clin Psychopharmacol. 26 (2006) 524-529