{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T22:49:53Z","timestamp":1777934993524,"version":"3.51.4"},"reference-count":17,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2013,3,8]],"date-time":"2013-03-08T00:00:00Z","timestamp":1362700800000},"content-version":"vor","delay-in-days":3294,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2004,3]]},"abstract":"<jats:p>This trial was conducted to evaluate the pharmacokinetics and safety of a sodium oxybate (gamma\u2010hydroxybutyrate [GHB]) oral solution in narcoleptic patients after acute and chronic treatment. An open\u2010label, two\u2010period, two\u2010treatment study design was used. Trial subjects included 13 patients with polysomnographically confirmed narcolepsy. The patients were administered a bedtime dose of 4.5 g of sodium oxybate while in a sleep research center. They were subsequently treated with sodium oxybate at the nightly dose of 4.5 g for 8 weeks. The patients then returned to the sleep center and were again treated with the 4.5\u2010g sodium oxybate dose at bedtime. Blood samples (5 mL) were collected at 18 time points before and up to 7 hours after both the first dose of sodium oxybate and following 8 weeks of dosing. Plasma samples were analyzed for oxybate content by a validated liquid chromatography\/tandem mass spectrometry (LC\/MS\/ MS) method. Noncompartmental methods were applied in the determination of pharmacokinetic parameters from each patient's plasma oxybate concentration versus time curve. No serious adverse events were recorded, and all patients completed the study. Headache, enuresis, and leg cramps were reported as adverse experiences. With both acute and chronic dosing, sodium oxybate was rapidly absorbed and eliminated with an apparent half\u2010life of about 40 minutes. The only changes observed in the kinetics of oxybate after 8 weeks of treatment were a 13% and 16% increase in peak concentration (C<jats:sub><jats:italic>max<\/jats:italic><\/jats:sub>) and systemic exposure (AUC), respectively. The pharmacokinetics of sodium oxybate in narcoleptic patients were not changed in any clinically significant manner when the drug was chronically administered. The drug was well tolerated.<\/jats:p>","DOI":"10.1177\/0091270003262795","type":"journal-article","created":{"date-parts":[[2004,2,18]],"date-time":"2004-02-18T23:47:55Z","timestamp":1077148075000},"page":"253-257","source":"Crossref","is-referenced-by-count":69,"title":["The Pharmacokinetics of Sodium Oxybate Oral Solution following Acute and Chronic Administration to Narcoleptic Patients"],"prefix":"10.1002","volume":"44","author":[{"given":"Lowell A.","family":"Borgen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard A.","family":"Okerholm","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allen","family":"Lai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin B.","family":"Scharf","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,3,8]]},"reference":[{"key":"e_1_2_5_2_2","first-page":"659","volume-title":"Narcolepsy","author":"Broughton R","year":"1976"},{"issue":"1","key":"e_1_2_5_3_2","first-page":"1","article-title":"The treatment of narcolepsy\u2010cataplexy with nocturnal gamma\u2010hydroxybutyrate","volume":"6","author":"Broughton R","year":"1979","journal-title":"Le Journal Canadien Des Sciences Neurologiques"},{"issue":"1","key":"e_1_2_5_4_2","first-page":"23","article-title":"Effects of nocturnal gamma\u2010hydroxybutyrate on sleep\/waking patterns in narcolepsy\u2014cataplexy","volume":"7","author":"Broughton R","year":"1980","journal-title":"Le Journal Canadien Des Sciences Neurologique"},{"issue":"6","key":"e_1_2_5_5_2","first-page":"222","article-title":"The effects and effectiveness of \u03b3\u2010hydroxybutyrate in patients with narcolepsy","volume":"46","author":"Scharf MB","year":"1985","journal-title":"J Clin Psychiatry"},{"key":"e_1_2_5_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/0006-3223(89)90048-6"},{"issue":"6","key":"e_1_2_5_7_2","doi-asserted-by":"crossref","first-page":"479","DOI":"10.1093\/sleep\/13.6.479","article-title":"The effects of \u03b3\u2010hydroxybutyrate on the sleep of narcolepsy patients: a double\u2010blind study","volume":"13","author":"Scrima L","year":"1990","journal-title":"Sleep"},{"issue":"3","key":"e_1_2_5_8_2","doi-asserted-by":"crossref","first-page":"216","DOI":"10.1093\/sleep\/16.3.216","article-title":"Gammahydroxybutyrate and narcolepsy: a double\u2010blind placebo\u2010controlled study","volume":"16","author":"Lammers GJ","year":"1993","journal-title":"Sleep"},{"key":"e_1_2_5_9_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF00265954"},{"key":"e_1_2_5_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/0091270002239707"},{"key":"e_1_2_5_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050113"},{"key":"e_1_2_5_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1992.tb04129.x"},{"key":"e_1_2_5_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/21.5.507"},{"issue":"50","key":"e_1_2_5_14_2","first-page":"1257","article-title":"Capacity\u2010limited elimination of 4\u2010hydroxybutyrate (Gamma OH\u00ae), ethanol and vinylbital (Bykonox\u00ae)","volume":"110","author":"Vreey TB","year":"1975","journal-title":"Pharmaceutisch Weekblad"},{"key":"e_1_2_5_15_2","first-page":"21","article-title":"Pharmacokinetics of 4\u2010hydroxybutyric acid in man, rhesus monkey and dog","volume":"110","author":"Vree TB","year":"1978","journal-title":"Anaesthesiol Intensivmed"},{"issue":"1","key":"e_1_2_5_16_2","first-page":"93","article-title":"Gamma\u2010hydroxybutyric acid as hypnotic: clinical and pharmacokinetic evaluation of gamma\u2010hydroxybutyric acid as a hypnotic in man","volume":"6","author":"Hoes MJ","year":"1980","journal-title":"L'Encephale"},{"issue":"3","key":"e_1_2_5_17_2","first-page":"185","article-title":"Pharmacokinetics of \u03b3\u2010hydroxybutyric acid","volume":"8","author":"Palatini P","year":"1996","journal-title":"Alcologia"},{"issue":"1","key":"e_1_2_5_18_2","first-page":"42","article-title":"A randomized, double blind, placebo\u2010controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy","volume":"25","author":"U.S. Xyrem Multicenter Study Group","year":"2002","journal-title":"Sleep"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1177%2F0091270003262795","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1177\/0091270003262795","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,12]],"date-time":"2023-10-12T11:16:16Z","timestamp":1697109376000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1177\/0091270003262795"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2004,3]]},"references-count":17,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2004,3]]}},"alternative-id":["10.1177\/0091270003262795"],"URL":"https:\/\/doi.org\/10.1177\/0091270003262795","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2004,3]]}}}