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Forty participants received 0.5, 1, 2, or 4 mg zaleplon or placebo as a thermally generated aerosol in a randomized, double\u2010blind, parallel\u2010group, dose escalation study. Blood was collected up to 24 hours after dosing, and sedation was assessed up to 8 hours. Following inhalation, the observed median time to maximum plasma concentrations (25%, 75%) was 1.89 (1.45, 3.08) minutes and the mean (SD) elimination half\u2010life was 1.24 (0.24) hours. The equilibration half\u2010life for sedation (t<jats:sub>1\/2<\/jats:sub>k<jats:sub>e0<\/jats:sub>) was 1.16 (0.62, 2.17) minutes. The zaleplon AUC was dose proportional across doses, with a slope (90% confidence interval) of log\u2010AUC versus log\u2010dose of 0.92 (0.82, 1.02). No clinically significant changes were noted in laboratory values, vital signs, or spirometry. The most common adverse events were dizziness, somnolence, euphoria, headache, and visual disturbance. Zaleplon inhalation represents a safe, well\u2010tolerated means of rapidly achieving effective plasma concentrations.<\/jats:p><\/jats:sec>","DOI":"10.1177\/0091270012436886","type":"journal-article","created":{"date-parts":[[2012,2,16]],"date-time":"2012-02-16T04:38:59Z","timestamp":1329367139000},"page":"140-150","source":"Crossref","is-referenced-by-count":4,"title":["The Pharmacokinetics and Pharmacodynamics of Zaleplon Delivered as a Thermally Generated Aerosol in a Single Breath to Volunteers"],"prefix":"10.1002","volume":"53","author":[{"given":"Michael J.","family":"Avram","sequence":"first","affiliation":[{"name":"Department of Anesthesiology and Mary Beth Donnelley Clinical Pharmacology Core Facility of the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine  Chicago, IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel A.","family":"Spyker","sequence":"additional","affiliation":[{"name":"Alexza Pharmaceuticals, Inc  Mountain View, CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John H.","family":"Kehne","sequence":"additional","affiliation":[{"name":"Translational Neuropharmacology Consulting  Potomac, MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James V.","family":"Cassella","sequence":"additional","affiliation":[{"name":"Alexza Pharmaceuticals, Inc  Mountain View, CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,2,22]]},"reference":[{"issue":"10","key":"e_1_2_8_2_1","first-page":"3","article-title":"New developments for treating sleep disorders","volume":"62","author":"Roth T","year":"2001","journal-title":"J Clin Psychiatry"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1098-3597(03)90031-7"},{"key":"e_1_2_8_4_1","doi-asserted-by":"crossref","unstructured":"National Institutes of Health. 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