{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T07:17:23Z","timestamp":1791357443547,"version":"4.3.1"},"reference-count":24,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2019,3,13]],"date-time":"2019-03-13T00:00:00Z","timestamp":1552435200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Solriamfetol (JZP\u2010110), a selective dopamine and norepinephrine reuptake inhibitor with wake\u2010promoting effects, is renally excreted \u223c90% unchanged within 48\u00a0hours. Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of 75\u2010mg single\u2010dose solriamfetol were evaluated in adults with normal renal function (n = 6); mild (n = 6), moderate (n = 6), or severe (n = 6) renal impairment; and end\u2010stage renal disease (ESRD) with and without hemodialysis (n = 7). Relative to normal renal function, geometric mean area under the plasma concentration\u2013time curve from time zero to infinity increased 53%, 129%, and 339%, and mean half\u2010life was 1.2\u2010, 1.9\u2010, and 3.9\u2010fold higher with mild, moderate, and severe renal impairment, respectively. Renal excretion of unchanged solriamfetol over 48\u00a0hours was 85.8%, 80.0%, 66.4%, and 57.1% in normal, mild, moderate, and severe renal impairment groups, respectively; mean maximum concentration and time to maximum concentration did not vary substantially. Decreases in solriamfetol clearance were proportional to decreases in estimated glomerular filtration rate. Geometric mean area under the plasma concentration\u2013time curve from time zero to time of last quantifiable concentration increased 357% and 518% vs normal in ESRD with and without hemodialysis, respectively, with half\u2010life &gt;100\u00a0hours in both groups. Over the 4\u2010hour hemodialysis period, \u223c21% of solriamfetol dose was removed. Adverse events included headache (n = 1) and nausea (n = 1). Six days after dosing, 1 participant had increased alanine and aspartate aminotransferase, leading to study discontinuation. While these adverse events were deemed study\u2010drug related, they were mild and resolved. Results from this study combined with population pharmacokinetic modeling\/simulation suggest that solriamfetol dosage adjustments are necessary in patients with moderate or severe but not with mild renal impairment. Due to significant exposure increase\/prolonged half\u2010life, dosing is not recommended in patients with ESRD.<\/jats:p>","DOI":"10.1002\/jcph.1402","type":"journal-article","created":{"date-parts":[[2019,3,13]],"date-time":"2019-03-13T15:16:06Z","timestamp":1552490166000},"page":"1120-1129","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Single\u2010Dose Pharmacokinetics and Safety of Solriamfetol in Participants With Normal or Impaired Renal Function and With End\u2010Stage Renal Disease Requiring Hemodialysis"],"prefix":"10.1002","volume":"59","author":[{"given":"Katie","family":"Zomorodi","sequence":"first","affiliation":[{"name":"Jazz Pharmaceuticals  Palo Alto CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Chen","sequence":"additional","affiliation":[{"name":"Jazz Pharmaceuticals  Palo Alto CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Lee","sequence":"additional","affiliation":[{"name":"Jazz Pharmaceuticals  Palo Alto CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Lasseter","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology of Miami, Inc  Miami FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Marbury","sequence":"additional","affiliation":[{"name":"Orlando Clinical Research Center  Orlando FL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,3,13]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"CarterL BaladiM BlackJ.JZP\u2010110: a dopamine\u2010norepinephrine reuptake inhibitor (DNRI) with robust wake\u2010promoting effects and low abuse potential. Poster presented at: Winter Conference on Brain Research; January 23\u201028 2016; Breckenridge Colorado. 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Pharmacokinetics in patients with impaired renal function\u2014study design data analysis and impact on dosing and labeling.http:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm204959.pdf. Published 2010. Accessed January 11 2019."},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleepj\/zsx050.1026"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-145-4-200608150-00004"},{"key":"e_1_2_10_12_1","unstructured":"International Conference on Harmonisation.Guideline for Industry. Clinical safety data management: definitions and standards for expedited reporting.https:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E2A\/Step4\/E2A_Guideline.pdf. Published 1994. 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