Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men
Suvorexant (MK-4305) is an orexin receptor antagonist being developed for the treatment of insomnia. This report describes the effects of nighttime administration of suvorexant on polysomnography (PSG) sleep parameters in healthy young men. Randomized, double-blind, placebo-controlled, 4-period cros...
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| Veröffentlicht in: | Sleep (New York, N.Y.) N.Y.), 2013-02, Vol.36 (2), p.259-267 |
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| creator | Sun, Hong Kennedy, William P Wilbraham, Darren Lewis, Nicole Calder, Nicole Li, Xiaodong Ma, Junshui Yee, Ka Lai Ermlich, Susan Mangin, Eric Lines, Christopher Rosen, Laura Chodakewitz, Jeffrey Murphy, Gail M |
| description | Suvorexant (MK-4305) is an orexin receptor antagonist being developed for the treatment of insomnia. This report describes the effects of nighttime administration of suvorexant on polysomnography (PSG) sleep parameters in healthy young men.
Randomized, double-blind, placebo-controlled, 4-period crossover PSG study, followed by an additional 5(th) period to assess pharmacokinetics.
Sleep laboratory.
Healthy young men between 18 and 45 years of age (22 enrolled, 19 completed).
Periods 1-4: suvorexant (10 mg, 50 mg, or 100 mg) or placebo 1 h before nighttime PSG recording. Period 5: suvorexant 10 mg, 50 mg, or 100 mg.
In Periods 1-4, overnight sleep parameters were recorded by PSG and next-morning residual effects were assessed by psychomotor performance tests and subjective assessments. Statistically significant sleep-promoting effects were observed with all doses of suvorexant compared to placebo. Suvorexant 50 mg and 100 mg significantly decreased latency to persistent sleep and wake after sleep onset time, and increased sleep efficiency. Suvorexant 10 mg significantly decreased wake after sleep onset time. There were no statistically significant effects of suvorexant on EEG frequency bands including delta (slow wave) activity based on power spectral analysis. Suvorexant was well tolerated. There was no evidence of next-day residual effects for suvorexant 10 mg. Suvorexant 50 mg statistically significantly reduced subjective alertness, and suvorexant 100 mg significantly increased reaction time and reduced subjective alertness. There were no statistically significant effects of any suvorexant dose on digit symbol substitution test performance. In Period 5, plasma samples of suvorexant were collected for pharmacokinetic evaluation. The median T(max) was 3 hours and apparent terminal t(½) was 9-13 hours.
In healthy young men without sleep disorders, suvorexant promoted sleep with some evidence of residual effects at the highest doses. |
| doi_str_mv | 10.5665/sleep.2386 |
| format | Article |
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Randomized, double-blind, placebo-controlled, 4-period crossover PSG study, followed by an additional 5(th) period to assess pharmacokinetics.
Sleep laboratory.
Healthy young men between 18 and 45 years of age (22 enrolled, 19 completed).
Periods 1-4: suvorexant (10 mg, 50 mg, or 100 mg) or placebo 1 h before nighttime PSG recording. Period 5: suvorexant 10 mg, 50 mg, or 100 mg.
In Periods 1-4, overnight sleep parameters were recorded by PSG and next-morning residual effects were assessed by psychomotor performance tests and subjective assessments. Statistically significant sleep-promoting effects were observed with all doses of suvorexant compared to placebo. Suvorexant 50 mg and 100 mg significantly decreased latency to persistent sleep and wake after sleep onset time, and increased sleep efficiency. Suvorexant 10 mg significantly decreased wake after sleep onset time. There were no statistically significant effects of suvorexant on EEG frequency bands including delta (slow wave) activity based on power spectral analysis. Suvorexant was well tolerated. There was no evidence of next-day residual effects for suvorexant 10 mg. Suvorexant 50 mg statistically significantly reduced subjective alertness, and suvorexant 100 mg significantly increased reaction time and reduced subjective alertness. There were no statistically significant effects of any suvorexant dose on digit symbol substitution test performance. In Period 5, plasma samples of suvorexant were collected for pharmacokinetic evaluation. The median T(max) was 3 hours and apparent terminal t(½) was 9-13 hours.
In healthy young men without sleep disorders, suvorexant promoted sleep with some evidence of residual effects at the highest doses.</description><identifier>ISSN: 0161-8105</identifier><identifier>EISSN: 1550-9109</identifier><identifier>DOI: 10.5665/sleep.2386</identifier><identifier>PMID: 23372274</identifier><language>eng</language><publisher>United States: Associated Professional Sleep Societies, LLC</publisher><subject>Adolescent ; Adult ; Azepines - adverse effects ; Azepines - pharmacokinetics ; Azepines - pharmacology ; Cross-Over Studies ; Double-Blind Method ; Effects of an Orexin Receptor Antagonist on Sleep ; Humans ; Hypnotics and Sedatives - adverse effects ; Hypnotics and Sedatives - pharmacokinetics ; Hypnotics and Sedatives - pharmacology ; Male ; Orexin Receptors ; Polysomnography ; Receptors, G-Protein-Coupled - antagonists & inhibitors ; Receptors, Neuropeptide - antagonists & inhibitors ; Sleep - drug effects ; Sleep - physiology ; Triazoles - adverse effects ; Triazoles - pharmacokinetics ; Triazoles - pharmacology ; Young Adult</subject><ispartof>Sleep (New York, N.Y.), 2013-02, Vol.36 (2), p.259-267</ispartof><rights>2013 Associated Professional Sleep Societies, LLC. 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c444t-9c4b159ff8348c598453117f03d53cca4c7f98087706d35ef5416b01067e2eaf3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23372274$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sun, Hong</creatorcontrib><creatorcontrib>Kennedy, William P</creatorcontrib><creatorcontrib>Wilbraham, Darren</creatorcontrib><creatorcontrib>Lewis, Nicole</creatorcontrib><creatorcontrib>Calder, Nicole</creatorcontrib><creatorcontrib>Li, Xiaodong</creatorcontrib><creatorcontrib>Ma, Junshui</creatorcontrib><creatorcontrib>Yee, Ka Lai</creatorcontrib><creatorcontrib>Ermlich, Susan</creatorcontrib><creatorcontrib>Mangin, Eric</creatorcontrib><creatorcontrib>Lines, Christopher</creatorcontrib><creatorcontrib>Rosen, Laura</creatorcontrib><creatorcontrib>Chodakewitz, Jeffrey</creatorcontrib><creatorcontrib>Murphy, Gail M</creatorcontrib><title>Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men</title><title>Sleep (New York, N.Y.)</title><addtitle>Sleep</addtitle><description>Suvorexant (MK-4305) is an orexin receptor antagonist being developed for the treatment of insomnia. This report describes the effects of nighttime administration of suvorexant on polysomnography (PSG) sleep parameters in healthy young men.
Randomized, double-blind, placebo-controlled, 4-period crossover PSG study, followed by an additional 5(th) period to assess pharmacokinetics.
Sleep laboratory.
Healthy young men between 18 and 45 years of age (22 enrolled, 19 completed).
Periods 1-4: suvorexant (10 mg, 50 mg, or 100 mg) or placebo 1 h before nighttime PSG recording. Period 5: suvorexant 10 mg, 50 mg, or 100 mg.
In Periods 1-4, overnight sleep parameters were recorded by PSG and next-morning residual effects were assessed by psychomotor performance tests and subjective assessments. Statistically significant sleep-promoting effects were observed with all doses of suvorexant compared to placebo. Suvorexant 50 mg and 100 mg significantly decreased latency to persistent sleep and wake after sleep onset time, and increased sleep efficiency. Suvorexant 10 mg significantly decreased wake after sleep onset time. There were no statistically significant effects of suvorexant on EEG frequency bands including delta (slow wave) activity based on power spectral analysis. Suvorexant was well tolerated. There was no evidence of next-day residual effects for suvorexant 10 mg. Suvorexant 50 mg statistically significantly reduced subjective alertness, and suvorexant 100 mg significantly increased reaction time and reduced subjective alertness. There were no statistically significant effects of any suvorexant dose on digit symbol substitution test performance. In Period 5, plasma samples of suvorexant were collected for pharmacokinetic evaluation. The median T(max) was 3 hours and apparent terminal t(½) was 9-13 hours.
In healthy young men without sleep disorders, suvorexant promoted sleep with some evidence of residual effects at the highest doses.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Azepines - adverse effects</subject><subject>Azepines - pharmacokinetics</subject><subject>Azepines - pharmacology</subject><subject>Cross-Over Studies</subject><subject>Double-Blind Method</subject><subject>Effects of an Orexin Receptor Antagonist on Sleep</subject><subject>Humans</subject><subject>Hypnotics and Sedatives - adverse effects</subject><subject>Hypnotics and Sedatives - pharmacokinetics</subject><subject>Hypnotics and Sedatives - pharmacology</subject><subject>Male</subject><subject>Orexin Receptors</subject><subject>Polysomnography</subject><subject>Receptors, G-Protein-Coupled - antagonists & inhibitors</subject><subject>Receptors, Neuropeptide - antagonists & inhibitors</subject><subject>Sleep - drug effects</subject><subject>Sleep - physiology</subject><subject>Triazoles - adverse effects</subject><subject>Triazoles - pharmacokinetics</subject><subject>Triazoles - pharmacology</subject><subject>Young Adult</subject><issn>0161-8105</issn><issn>1550-9109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUMtOwzAQtBCIlsKFD0A-I1Ls2E6cCxKqykOqxAXOkeOu26DEjmwXyN-TtlDBaWd3ZmekQeiSkqnIMnEbGoBumjKZHaExFYIkBSXFMRoTmtFEUiJG6CyEdzLsvGCnaJQylqdpzsfoc24M6BiwMzhsPpyHL2XjDVYWb3FtsQcNXXR-OEW1crYOA-0s3qXiTnnVQgQfsAq4BRU2Hpa46nHnmj641rqVV926x4PVGlQTB9iCPUcnRjUBLn7mBL09zF9nT8ni5fF5dr9INOc8JoXmFRWFMZJxqUUhuWCU5oawpWBaK65zU0gi85xkSybACE6zilCS5ZCCMmyC7va-3aZqYanBRq-asvN1q3xfOlWX_xlbr8uV-yiZ4Gkhs8Hgem-gvQvBgzn8UlJu6y93RZTb-gfx1d-0g_S3b_YNYXCE6w</recordid><startdate>20130201</startdate><enddate>20130201</enddate><creator>Sun, Hong</creator><creator>Kennedy, William P</creator><creator>Wilbraham, Darren</creator><creator>Lewis, Nicole</creator><creator>Calder, Nicole</creator><creator>Li, Xiaodong</creator><creator>Ma, Junshui</creator><creator>Yee, Ka Lai</creator><creator>Ermlich, Susan</creator><creator>Mangin, Eric</creator><creator>Lines, Christopher</creator><creator>Rosen, Laura</creator><creator>Chodakewitz, Jeffrey</creator><creator>Murphy, Gail M</creator><general>Associated Professional Sleep Societies, LLC</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20130201</creationdate><title>Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men</title><author>Sun, Hong ; Kennedy, William P ; Wilbraham, Darren ; Lewis, Nicole ; Calder, Nicole ; Li, Xiaodong ; Ma, Junshui ; Yee, Ka Lai ; Ermlich, Susan ; Mangin, Eric ; Lines, Christopher ; Rosen, Laura ; Chodakewitz, Jeffrey ; Murphy, Gail M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c444t-9c4b159ff8348c598453117f03d53cca4c7f98087706d35ef5416b01067e2eaf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Azepines - adverse effects</topic><topic>Azepines - pharmacokinetics</topic><topic>Azepines - pharmacology</topic><topic>Cross-Over Studies</topic><topic>Double-Blind Method</topic><topic>Effects of an Orexin Receptor Antagonist on Sleep</topic><topic>Humans</topic><topic>Hypnotics and Sedatives - adverse effects</topic><topic>Hypnotics and Sedatives - pharmacokinetics</topic><topic>Hypnotics and Sedatives - pharmacology</topic><topic>Male</topic><topic>Orexin Receptors</topic><topic>Polysomnography</topic><topic>Receptors, G-Protein-Coupled - antagonists & inhibitors</topic><topic>Receptors, Neuropeptide - antagonists & inhibitors</topic><topic>Sleep - drug effects</topic><topic>Sleep - physiology</topic><topic>Triazoles - adverse effects</topic><topic>Triazoles - pharmacokinetics</topic><topic>Triazoles - pharmacology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sun, Hong</creatorcontrib><creatorcontrib>Kennedy, William P</creatorcontrib><creatorcontrib>Wilbraham, Darren</creatorcontrib><creatorcontrib>Lewis, Nicole</creatorcontrib><creatorcontrib>Calder, Nicole</creatorcontrib><creatorcontrib>Li, Xiaodong</creatorcontrib><creatorcontrib>Ma, Junshui</creatorcontrib><creatorcontrib>Yee, Ka Lai</creatorcontrib><creatorcontrib>Ermlich, Susan</creatorcontrib><creatorcontrib>Mangin, Eric</creatorcontrib><creatorcontrib>Lines, Christopher</creatorcontrib><creatorcontrib>Rosen, Laura</creatorcontrib><creatorcontrib>Chodakewitz, Jeffrey</creatorcontrib><creatorcontrib>Murphy, Gail M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Sleep (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sun, Hong</au><au>Kennedy, William P</au><au>Wilbraham, Darren</au><au>Lewis, Nicole</au><au>Calder, Nicole</au><au>Li, Xiaodong</au><au>Ma, Junshui</au><au>Yee, Ka Lai</au><au>Ermlich, Susan</au><au>Mangin, Eric</au><au>Lines, Christopher</au><au>Rosen, Laura</au><au>Chodakewitz, Jeffrey</au><au>Murphy, Gail M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men</atitle><jtitle>Sleep (New York, N.Y.)</jtitle><addtitle>Sleep</addtitle><date>2013-02-01</date><risdate>2013</risdate><volume>36</volume><issue>2</issue><spage>259</spage><epage>267</epage><pages>259-267</pages><issn>0161-8105</issn><eissn>1550-9109</eissn><abstract>Suvorexant (MK-4305) is an orexin receptor antagonist being developed for the treatment of insomnia. This report describes the effects of nighttime administration of suvorexant on polysomnography (PSG) sleep parameters in healthy young men.
Randomized, double-blind, placebo-controlled, 4-period crossover PSG study, followed by an additional 5(th) period to assess pharmacokinetics.
Sleep laboratory.
Healthy young men between 18 and 45 years of age (22 enrolled, 19 completed).
Periods 1-4: suvorexant (10 mg, 50 mg, or 100 mg) or placebo 1 h before nighttime PSG recording. Period 5: suvorexant 10 mg, 50 mg, or 100 mg.
In Periods 1-4, overnight sleep parameters were recorded by PSG and next-morning residual effects were assessed by psychomotor performance tests and subjective assessments. Statistically significant sleep-promoting effects were observed with all doses of suvorexant compared to placebo. Suvorexant 50 mg and 100 mg significantly decreased latency to persistent sleep and wake after sleep onset time, and increased sleep efficiency. Suvorexant 10 mg significantly decreased wake after sleep onset time. There were no statistically significant effects of suvorexant on EEG frequency bands including delta (slow wave) activity based on power spectral analysis. Suvorexant was well tolerated. There was no evidence of next-day residual effects for suvorexant 10 mg. Suvorexant 50 mg statistically significantly reduced subjective alertness, and suvorexant 100 mg significantly increased reaction time and reduced subjective alertness. There were no statistically significant effects of any suvorexant dose on digit symbol substitution test performance. In Period 5, plasma samples of suvorexant were collected for pharmacokinetic evaluation. The median T(max) was 3 hours and apparent terminal t(½) was 9-13 hours.
In healthy young men without sleep disorders, suvorexant promoted sleep with some evidence of residual effects at the highest doses.</abstract><cop>United States</cop><pub>Associated Professional Sleep Societies, LLC</pub><pmid>23372274</pmid><doi>10.5665/sleep.2386</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0161-8105 |
| ispartof | Sleep (New York, N.Y.), 2013-02, Vol.36 (2), p.259-267 |
| issn | 0161-8105 1550-9109 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3542986 |
| source | MEDLINE; Oxford Journals - Connect here FIRST to enable access; Alma/SFX Local Collection; EZB Electronic Journals Library |
| subjects | Adolescent Adult Azepines - adverse effects Azepines - pharmacokinetics Azepines - pharmacology Cross-Over Studies Double-Blind Method Effects of an Orexin Receptor Antagonist on Sleep Humans Hypnotics and Sedatives - adverse effects Hypnotics and Sedatives - pharmacokinetics Hypnotics and Sedatives - pharmacology Male Orexin Receptors Polysomnography Receptors, G-Protein-Coupled - antagonists & inhibitors Receptors, Neuropeptide - antagonists & inhibitors Sleep - drug effects Sleep - physiology Triazoles - adverse effects Triazoles - pharmacokinetics Triazoles - pharmacology Young Adult |
| title | Effects of suvorexant, an orexin receptor antagonist, on sleep parameters as measured by polysomnography in healthy men |
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