A safety trial of sodium oxybate in patients with obstructive sleep apnea: Acute effects on sleep-disordered breathing

Sleep Medicine

Volumn 11, Issue 1, 2010, Pages 38-42

  George, Charles F P ^a   Feldman, Neil ^b   Inhaber, Neil ^c   Steininger, Teresa L ^c   Grzeschik, Susanna M ^c   Lai, Chinglin ^d   Zheng, Yanping ^c  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b Clinical Research Group of St Petersburg   (United States)

^c JAZZ PHARMACEUTICALS   (United States)

^d Otsuka America Pharmaceutical Inc   (United States)

Author keywords

Apnea hypopnea index; Gamma hydroxybutyrate GHB; Hypoxemia; Oxygen saturation; Polysomnography; Sleep apnea; Slow wave sleep; Xyrem sodium oxybate

Indexed keywords

MODAFINIL; OXYBATE SODIUM; PLACEBO; ZOLPIDEM;

ADULT; AGED; ARTICLE; CATALEPSY; CATAPLEXY; CENTRAL NERVOUS SYSTEM FUNCTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DAYTIME SOMNOLENCE; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DRUG FATALITY; DRUG POTENTIATION; DRUG WITHDRAWAL; EVENING DOSAGE; FEMALE; HEADACHE; HUMAN; HYPESTHESIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NARCOLEPSY; NAUSEA; OXYGEN SATURATION; POLYSOMNOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SHIFT WORKER; SLEEP APNEA SYNDROME; SLEEP DISORDERED BREATHING;

ADJUVANTS, ANESTHESIA; ADULT; AGED; BENZHYDRYL COMPOUNDS; CENTRAL NERVOUS SYSTEM STIMULANTS; COMORBIDITY; CONTINUOUS POSITIVE AIRWAY PRESSURE; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; DRUG TOXICITY; FEMALE; HUMANS; HYPNOTICS AND SEDATIVES; MALE; MIDDLE AGED; NARCOLEPSY; OXYGEN; POLYSOMNOGRAPHY; PRODUCT SURVEILLANCE, POSTMARKETING; PYRIDINES; SLEEP APNEA, OBSTRUCTIVE; SLEEP STAGES; SODIUM OXYBATE;

EID: 73149113942     PISSN: 13899457     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.sleep.2009.06.006     Document Type: Article

References (21)

1. McArdle N., and Douglas N.J. Effect of continuous positive airway pressure on sleep architecture in the sleep apnea-hypopnea syndrome: a randomized controlled trial. Am J Respir Crit Care Med 164 8 Pt 1 (2001) 1459-1663
2. Loredo J.S., Ancoli-Israel S., and Dimsdale J.E. Effect of continuous positive airway pressure vs placebo continuous positive airway pressure on sleep quality in obstructive sleep apnea. Chest 116 (1999) 1545-1549
3. Laborit H. Sodium 4-hydroxybutyrate. Int J Neuropharmacol 32 (1964) 433-451
4. Kleinschmidt S., Schellhase C., and Mertzlufft F. Continuous sedation during spinal anaesthesia: gamma-hydroxybutyrate vs. propofol. Eur J Anaesthesiol 16 1 (1999) 23-30
5. Mason P.E., and Kerns WP 2n. Gamma hydroxybutyric acid (GHB) intoxication. Acad Emerg Med 9 7 (2002) 730-739
6. Santamaria J., Sansa G., and Iranzo A. Prevalence and clinical relevance of sleep apnea in narcolepsy. Sleep 30 Suppl. (2007) A224-A225
7. Chokroverty S. Sleep apnea in narcolepsy. Sleep 9 1 Pt. 2 (1986) 250-253
8. Zozula R., and Rosen R. Compliance with continuous positive airway pressure therapy: assessing and improving treatment outcomes. Curr Opin Pulm Med 7 6 (2001) 391-398
9. Sériès F., Sériès I., and Cormier Y. Effects of enhancing slow-wave sleep by gamma-hydroxybutyrate on obstructive sleep apnea. Am Rev Respir Dis 145 6 (1992) 1378-1383
10. Mamelak M., and Webster P. Treatment of narcolepsy and sleep apnea with gammahydroxybutyrate: a clinical and polysomnographic case study. Sleep 4 1 (1981) 105-111
11. Black J.E., Ristanovic R., Mamelak M., and Montplaisir J. Effect of increasing doses of sodium oxybate on nocturnal oxygen saturation: preliminary findings. Sleep 25 Suppl. (2002) A474-A475
12. Ristanovic R., Black J., Mamelak M., and Montplaisir J. Analysis of dose effects of sodium oxybate on nocturnal respiratory disturbances. Sleep 25 Suppl. (2002) A473-A474
13. Seeck-Hirschner M., Baier P.C., von Freier A., Aldenhoff J., and 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 (2008) [Epub]
14. Bradshaw D.A., Ruff G.A., and Murphy D.P. An oral hypnotic medication does not improve continuous positive airway pressure compliance in men with obstructive sleep apnea. Chest 130 5 (2006) 1369-1376
15. ® (zolpidem tartrate) tablets prescribing information, sanofi-aventis US LLC, Bridgewater, NJ; 2007.
16. Cirignotta F., Mondini S., Zucconi M., Gerardi R., Farolfi A., and Lugaresi E. Zolpidem-polysomnographic study of the effect of a new hypnotic drug in sleep apnea syndrome. Pharmacol Biochem Behav 29 4 (1988) 807-809
17. Pack A.I., Black J.E., Schwartz J.R.L., and Matheson J.K. Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea. Am J Respir Crit Care Med 164 9 (2001) 1675-1681
18. Wise M.S., Arand D.L., Auger R.R., Brooks S.N., and Watson N.F. American Academy of Sleep Medicine. Treatment of narcolepsy and other hypersomnias of central origin. Sleep 30 12 (2007) 1712-1727
19. American Academy of Sleep Medicine Task Force. Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. Sleep 1999;22(5):667-689.
20. 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 7 (2004) 1327-1334
21. Le Bon O., Hoffmann G., Tecco J., Staner L., Noseda A., Pelc I., and Linkowski P. Mild to moderate sleep respiratory events: one negative night may not be enough. Chest 118 2 (2000) 353-359