The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy

Sleep Medicine

Volumn 10, Issue 8, 2009, Pages 829-835

  Black, Jed ^a   Pardi, Daniel ^b   Hornfeldt, Carl S ^c   Inhaber, Neil ^c  

^a STANFORD UNIVERSITY   (United States)

^b DSP Partners   (United States)

^c JAZZ PHARMACEUTICALS   (United States)

Author keywords

Gamma hydroxybutyrate; Modafinil; Narcolepsy; Polysomnography; Sleep architecture; Sodium oxybate

Indexed keywords

MODAFINIL; OXYBATE SODIUM; PLACEBO;

ABDOMINAL PAIN; ADULT; ARTICLE; BEDTIME DOSAGE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAYTIME SOMNOLENCE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EPWORTH SLEEPINESS SCALE; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD; NARCISSISM; NARCOLEPSY; NAUSEA; OUTCOME ASSESSMENT; PARESTHESIA; POLYSOMNOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SLEEP STAGE; SLEEP TIME; SLEEP WAKING CYCLE; SOMNOLENCE; TREATMENT OUTCOME; TREMOR; VOMITING; WAKEFULNESS;

ADJUVANTS, ANESTHESIA; ADULT; BENZHYDRYL COMPOUNDS; CENTRAL NERVOUS SYSTEM STIMULANTS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; NARCOLEPSY; PLACEBOS; POLYSOMNOGRAPHY; SLEEP; SLEEP DISORDERS; SODIUM OXYBATE; WAKEFULNESS;

EID: 68749088255     PISSN: 13899457     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.sleep.2009.05.004     Document Type: Article

References (32)

1. Yoss R.E., and Daly D.D. Criteria for the diagnosis of the narcolepsy syndrome. Proc Staff Meet Mayo Clin 32 (1957) 320-328
2. Fromherz S., and Mignot E. Narcolepsy research: past, present, and future perspectives. Arch Ital Biol 142 (2004) 479-486
3. Rechtschaffen A., Wolpert E.A., Dement W.C., Mitchell S.A., and Fisher C. Nocturnal sleep of narcoleptics. Electroencephalogr Clin Neurophysiol 15 (1963) 599-609
4. Plazzi G., Serra L., and Ferri R. Nocturnal aspects of narcolepsy with cataplexy. Sleep Med Rev 12 (2008) 109-128
5. Montplaisir J., Billiard M., Takahashi S., Bell I.R., Guilleminault C., and Dement W.C. Twenty-four-hour recording in REM-narcoleptics with special reference to nocturnal sleep disruption. Biol Psychiatry 13 (1978) 73-89
6. Broughton R., and Mamelak M. Effects of nocturnal gamma-hydroxybutyrate on sleep/waking patterns in narcolepsy-cataplexy. Can J Neurol Sci 7 (1980) 23-31
7. Baker T.L., Guilleminault C., Nino-Murcia G., and Dement W.C. Comparative polysomnographic study of narcolepsy and idiopathic central nervous system hypersomnia. Sleep 9 1 Pt 2 (1986) 232-242
8. Folkerts M., Rosenthal L., Roehrs T., Krstevska S., Murlidhar A., Zorick F., et al. The reliability of the diagnostic features in patients with narcolepsy. Biol Psychiatry 40 (1996) 208-214
9. Nishino S., Tafti M., Sampathkumaran R., Dement W.C., and Mignot E. Circadian distribution of rest/activity in narcoleptic and control dogs: assessment with ambulatory activity monitoring. J Sleep Res 6 (1997) 120-127
10. Nishino S., Riehl J., Hong J., Kwan M., Reid M., and Mignot E. Is narcolepsy a REM sleep disorder? Analysis of sleep abnormalities in narcoleptic Dobermans. Neurosci Res 38 (2000) 437-446
11. Beuckmann C.T., Sinton C.M., Williams S.C., Richardson J.A., Hammer R.E., Sakurai T., et al. Expression of a poly-glutamine-ataxin-3 transgene in orexin neurons induces narcolepsy-cataplexy in the rat. J Neurosci 24 (2004) 4469-4477
12. Mieda M., Willie J.T., Hara J., Sinton C.M., Sakurai T., and Yanagisawa M. Orexin peptides prevent cataplexy and improve wakefulness in an orexin neuron-ablated model of narcolepsy in mice. Proc Natl Acad Sci USA 101 (2004) 4649-4654
13. Zhang S., Lin L., Kaur S., Thankachan S., Blanco-Centurion C., Yanagisawa M., et al. The development of hypocretin deficiency in ataxin-hypocretin transgenic rats. Neuroscience 148 (2007) 34-43
14. Overeem S., Mignot E., van Dijk J.G., and Lammers G.J. Narcolepsy: clinical features, new pathophysiologic insights and future perspectives. J Clin Neurophysiol 18 (2001) 78-105
15. Hublin C. Narcolepsy. Current drug treatment options. CNS Drugs 5 (1996) 426-436
16. Rogers A.E., Aldrich M.S., and Caruso C.C. Patterns of sleep and wakefulness in treated narcoleptic subjects. Sleep 17 (1994) 590-597
17. Broughton R., and Mamelak M. The treatment of narcolepsy-cataplexy with nocturnal gamma-hydroxybutyrate. Can J Neurol Sci 6 (1979) 1-6
18. Scharf M.B., Brown D., Woods M., Borwn L., and Hirschowitz J. The effects and effectiveness of γ-hydroxybutyrate in patients with narcolepsy. J Clin Psychiatry 46 (1985) 222-225
19. Scrima L., Hartman P.G., Johnson Jr. F.H., and Hiller F.C. Efficacy of gamma-hydroxybutyrate versus placebo in treating narcolepsy-cataplexy: double blind subjective measures. Biol Psychiatry 26 (1989) 331-343
20. Scrima L., Hartman P.G., Johnson Jr. F.H., Thomas E.E., and Hiller F.C. The effects of γ-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep 13 (1990) 479-490
21. Lammers G.J., Arends J., Declerck A.C., Ferrari M.D., Schouwink G., and Troost J. Gamma-hydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep 16 (1993) 216-220
22. ® 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. Sleep 2002;25:42-9.
23. ® Multicenter Study Group. A 12-month, open-label, multi-center extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep, 2003;26:31-5.
24. ® Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med 2004;5:119-23.
25. ® 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 Med 2005;6:415-21.
26. ® International Study Group. A double-blind, placebo-controlled, study demonstrates the nightly administration of sodium oxybate significantly improves excessive daytime sleepiness in narcolepsy patients taking concurrent stimulant medications. J Clin Sleep Med 2005;1:391-7.
27. Black J., and Houghton W.C. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep 29 (2006) 939-946
28. International classification of sleep disorder. 2nd ed. Diagnostic and coding manual. Rochester, MN: American Academy of Sleep Medicine; 2005.
29. Mamelak M., Escriu J.M., and Stokan O. The effects of gamma-hydroxybutyrate on sleep. Biol Psychiatry 12 (1977) 273-288
30. Black J, Pardi D, Hornfeldt C, Inhaber N. The nightly use of sodium oxybate is associated with significant improvements in nocturnal sleep: a double-blind, placebo-controlled study in patients with narcolepsy. Unpublished manuscript.
31. Wise M.S., Arand D.L., Auger R.R., Brooks S.N., and Watson N.F. Treatment of narcolepsy and other hypersomnias of central origin. Sleep 30 (2007) 1712-1727
32. Thorpy M. Therapeutic advances in narcolepsy. Sleep Med 8 (2007) 427-440