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Early experience with the new DORA daridorexant in patients with insomnia disorder and comorbid mental disturbances: Results of a naturalistic study with 3 months follow‐up
Summary Insomnia disorder may affect mental health, increasing suicidal risk. Targeting insomnia is crucial in the clinical practice. Sixty‐six consecutive patients with insomnia disorder according with the DSM‐5‐TR criteria were treated with the dual orexin receptor antagonist, daridorexant 50 mg....
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| Published in: | Journal of sleep research 2024-12, Vol.33 (6), p.e14196-n/a |
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| creator | Palagini, Laura Alfi, Gaspare Gurrieri, Riccardo Annuzzi, Eric Caruso, Valerio Gambini, Matteo Grenno, Giovanna Trivella, Marco Presta, Silvio Miniati, Mario Pini, Stefano Perugi, Giulio Gemignani, Angelo |
| description | Summary
Insomnia disorder may affect mental health, increasing suicidal risk. Targeting insomnia is crucial in the clinical practice. Sixty‐six consecutive patients with insomnia disorder according with the DSM‐5‐TR criteria were treated with the dual orexin receptor antagonist, daridorexant 50 mg. Baseline (T0), 1 month (T1) and 3 month (T2) evaluations were performed. Insomnia severity (Insomnia Severity Index), mood, anxiety symptoms and suicidal risk (Beck Depression Inventory‐II, Young Mania Rating Scale, Self‐Reported Anxiety Scale, Suicidal Ideation Scale), dysfunctional insomnia‐cognitive factors and pre‐sleep arousal (Dysfunctional Beliefs About Sleep, Pre‐Sleep Arousal Scale) were evaluated. The final sample included 66 patients (n = 36, 54% females, mean age 60 ± 13.6 years). Most of them, 64%, suffered from insomnia disorder comorbid with unipolar/bipolar depression, anxiety disorders and substance use disorders. Repeated ANOVA analyses showed that Insomnia Severity Index, Dysfunctional Beliefs About Sleep and Pre‐Sleep Arousal Scale total score decreased across time (F = 68.818, p |
| doi_str_mv | 10.1111/jsr.14196 |
| format | article |
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Insomnia disorder may affect mental health, increasing suicidal risk. Targeting insomnia is crucial in the clinical practice. Sixty‐six consecutive patients with insomnia disorder according with the DSM‐5‐TR criteria were treated with the dual orexin receptor antagonist, daridorexant 50 mg. Baseline (T0), 1 month (T1) and 3 month (T2) evaluations were performed. Insomnia severity (Insomnia Severity Index), mood, anxiety symptoms and suicidal risk (Beck Depression Inventory‐II, Young Mania Rating Scale, Self‐Reported Anxiety Scale, Suicidal Ideation Scale), dysfunctional insomnia‐cognitive factors and pre‐sleep arousal (Dysfunctional Beliefs About Sleep, Pre‐Sleep Arousal Scale) were evaluated. The final sample included 66 patients (n = 36, 54% females, mean age 60 ± 13.6 years). Most of them, 64%, suffered from insomnia disorder comorbid with unipolar/bipolar depression, anxiety disorders and substance use disorders. Repeated ANOVA analyses showed that Insomnia Severity Index, Dysfunctional Beliefs About Sleep and Pre‐Sleep Arousal Scale total score decreased across time (F = 68.818, p < 0.001; F = 47.561, p < 0.001; F = 28.142, p < 0.001, respectively). Similarly, Beck Depression Inventory‐II, Self‐Reported Anxiety Scale, Young Mania Rating Scale, and Suicidal Ideation Scale significantly decreased over time (p < 0.001). Predictors of insomnia remission (Insomnia Severity Index < 8) at T1 were improvement of Insomnia Severity Index at T1 (F = 60.205, p < 0.001), and improvement of Dysfunctional Beliefs About Sleep at T1 (F = 4.432, p = 0.041). Insomnia remission at T2 was best predicted by improvement of Dysfunctional Beliefs About Sleep at T2 (F = 3.993, p = 0.023). Multiple‐regression models showed that clinical improvement of Beck Depression Inventory‐II was best predicted by improvement in Dysfunctional Beliefs About Sleep at T1 and T2, manic symptoms by Insomnia Severity Index at T2, anxiety symptoms by Dysfunctional Beliefs About Sleep, Insomnia Severity Index and somatic Pre‐Sleep Arousal Scale at T1 and T2. With the caution of a naturalistic design, early experience with daridorexant showed that by targeting insomnia it may be possible to improve not only insomnia symptoms but also comorbid symptoms.]]></description><identifier>ISSN: 0962-1105</identifier><identifier>ISSN: 1365-2869</identifier><identifier>EISSN: 1365-2869</identifier><identifier>DOI: 10.1111/jsr.14196</identifier><identifier>PMID: 38522432</identifier><language>eng</language><publisher>England</publisher><subject>Adult ; Aged ; anxiety ; Anxiety - drug therapy ; Anxiety Disorders - complications ; Anxiety Disorders - drug therapy ; Anxiety Disorders - epidemiology ; Comorbidity ; daridorexant ; depression ; dual orexin receptor antagonist ; Female ; Follow-Up Studies ; Humans ; insomnia ; insomnia therapy ; Male ; Mental Disorders - complications ; Mental Disorders - drug therapy ; Mental Disorders - epidemiology ; Middle Aged ; Orexin Receptor Antagonists - pharmacology ; Orexin Receptor Antagonists - therapeutic use ; Psychiatric Status Rating Scales ; Severity of Illness Index ; Sleep Initiation and Maintenance Disorders - drug therapy ; Suicidal Ideation ; Treatment Outcome</subject><ispartof>Journal of sleep research, 2024-12, Vol.33 (6), p.e14196-n/a</ispartof><rights>2024 European Sleep Research Society.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3256-6e92dae700b6f0bfd5bd0f13c2e11dd2a4459ca37f5b7cd2697a03d5d731f9ab3</citedby><cites>FETCH-LOGICAL-c3256-6e92dae700b6f0bfd5bd0f13c2e11dd2a4459ca37f5b7cd2697a03d5d731f9ab3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38522432$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Palagini, Laura</creatorcontrib><creatorcontrib>Alfi, Gaspare</creatorcontrib><creatorcontrib>Gurrieri, Riccardo</creatorcontrib><creatorcontrib>Annuzzi, Eric</creatorcontrib><creatorcontrib>Caruso, Valerio</creatorcontrib><creatorcontrib>Gambini, Matteo</creatorcontrib><creatorcontrib>Grenno, Giovanna</creatorcontrib><creatorcontrib>Trivella, Marco</creatorcontrib><creatorcontrib>Presta, Silvio</creatorcontrib><creatorcontrib>Miniati, Mario</creatorcontrib><creatorcontrib>Pini, Stefano</creatorcontrib><creatorcontrib>Perugi, Giulio</creatorcontrib><creatorcontrib>Gemignani, Angelo</creatorcontrib><title>Early experience with the new DORA daridorexant in patients with insomnia disorder and comorbid mental disturbances: Results of a naturalistic study with 3 months follow‐up</title><title>Journal of sleep research</title><addtitle>J Sleep Res</addtitle><description><![CDATA[Summary
Insomnia disorder may affect mental health, increasing suicidal risk. Targeting insomnia is crucial in the clinical practice. Sixty‐six consecutive patients with insomnia disorder according with the DSM‐5‐TR criteria were treated with the dual orexin receptor antagonist, daridorexant 50 mg. Baseline (T0), 1 month (T1) and 3 month (T2) evaluations were performed. Insomnia severity (Insomnia Severity Index), mood, anxiety symptoms and suicidal risk (Beck Depression Inventory‐II, Young Mania Rating Scale, Self‐Reported Anxiety Scale, Suicidal Ideation Scale), dysfunctional insomnia‐cognitive factors and pre‐sleep arousal (Dysfunctional Beliefs About Sleep, Pre‐Sleep Arousal Scale) were evaluated. The final sample included 66 patients (n = 36, 54% females, mean age 60 ± 13.6 years). Most of them, 64%, suffered from insomnia disorder comorbid with unipolar/bipolar depression, anxiety disorders and substance use disorders. Repeated ANOVA analyses showed that Insomnia Severity Index, Dysfunctional Beliefs About Sleep and Pre‐Sleep Arousal Scale total score decreased across time (F = 68.818, p < 0.001; F = 47.561, p < 0.001; F = 28.142, p < 0.001, respectively). Similarly, Beck Depression Inventory‐II, Self‐Reported Anxiety Scale, Young Mania Rating Scale, and Suicidal Ideation Scale significantly decreased over time (p < 0.001). Predictors of insomnia remission (Insomnia Severity Index < 8) at T1 were improvement of Insomnia Severity Index at T1 (F = 60.205, p < 0.001), and improvement of Dysfunctional Beliefs About Sleep at T1 (F = 4.432, p = 0.041). Insomnia remission at T2 was best predicted by improvement of Dysfunctional Beliefs About Sleep at T2 (F = 3.993, p = 0.023). Multiple‐regression models showed that clinical improvement of Beck Depression Inventory‐II was best predicted by improvement in Dysfunctional Beliefs About Sleep at T1 and T2, manic symptoms by Insomnia Severity Index at T2, anxiety symptoms by Dysfunctional Beliefs About Sleep, Insomnia Severity Index and somatic Pre‐Sleep Arousal Scale at T1 and T2. With the caution of a naturalistic design, early experience with daridorexant showed that by targeting insomnia it may be possible to improve not only insomnia symptoms but also comorbid symptoms.]]></description><subject>Adult</subject><subject>Aged</subject><subject>anxiety</subject><subject>Anxiety - drug therapy</subject><subject>Anxiety Disorders - complications</subject><subject>Anxiety Disorders - drug therapy</subject><subject>Anxiety Disorders - epidemiology</subject><subject>Comorbidity</subject><subject>daridorexant</subject><subject>depression</subject><subject>dual orexin receptor antagonist</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>insomnia</subject><subject>insomnia therapy</subject><subject>Male</subject><subject>Mental Disorders - complications</subject><subject>Mental Disorders - drug therapy</subject><subject>Mental Disorders - epidemiology</subject><subject>Middle Aged</subject><subject>Orexin Receptor Antagonists - pharmacology</subject><subject>Orexin Receptor Antagonists - therapeutic use</subject><subject>Psychiatric Status Rating Scales</subject><subject>Severity of Illness Index</subject><subject>Sleep Initiation and Maintenance Disorders - drug therapy</subject><subject>Suicidal Ideation</subject><subject>Treatment Outcome</subject><issn>0962-1105</issn><issn>1365-2869</issn><issn>1365-2869</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp10btuFDEYhmELgcgSKLgB5BKKSXxYz6zpohBOihRpgXr0z_i31pHHHuwZbbZLS8elcE25Ehwm0OHGhR-9Lj5CXnJ2wss5vc7phK-5rh-RFZe1qsSm1o_JiulaVJwzdUSe5XzNGG-U1E_JkdwoIdZSrMivC0j-QPFmxOQw9Ej3btrRaYc04J6-u9qeUQPJmZjwBsJEXaAjTIVOeaEu5DgEB9S4HJPBRCEY2schps4ZOhQJ_v5xmlMH5Yf8lm4xz74EoqVAA5QX8AW4nhZlDktY3t3-GGKYdpna6H3c393-nMfn5IkFn_HFw31Mvr2_-Hr-sbq8-vDp_Oyy6qVQdVWjFgawYayrLeusUZ1hlsteIOfGCFivle5BNlZ1TW9ErRtg0ijTSG41dPKYvF66Y4rfZ8xTO7jco_cQMM65FXqjGi3Vpin0zUL7FHNOaNsxuQHSoeWsvR-oLQO1fwYq9tVDdu4GNP_k30UKOF3A3nk8_L_Ufv6yXZK_ARZmoTw</recordid><startdate>202412</startdate><enddate>202412</enddate><creator>Palagini, Laura</creator><creator>Alfi, Gaspare</creator><creator>Gurrieri, Riccardo</creator><creator>Annuzzi, Eric</creator><creator>Caruso, Valerio</creator><creator>Gambini, Matteo</creator><creator>Grenno, Giovanna</creator><creator>Trivella, Marco</creator><creator>Presta, Silvio</creator><creator>Miniati, Mario</creator><creator>Pini, Stefano</creator><creator>Perugi, Giulio</creator><creator>Gemignani, Angelo</creator><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>7X8</scope></search><sort><creationdate>202412</creationdate><title>Early experience with the new DORA daridorexant in patients with insomnia disorder and comorbid mental disturbances: Results of a naturalistic study with 3 months follow‐up</title><author>Palagini, Laura ; Alfi, Gaspare ; Gurrieri, Riccardo ; Annuzzi, Eric ; Caruso, Valerio ; Gambini, Matteo ; Grenno, Giovanna ; Trivella, Marco ; Presta, Silvio ; Miniati, Mario ; Pini, Stefano ; Perugi, Giulio ; Gemignani, Angelo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3256-6e92dae700b6f0bfd5bd0f13c2e11dd2a4459ca37f5b7cd2697a03d5d731f9ab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Aged</topic><topic>anxiety</topic><topic>Anxiety - drug therapy</topic><topic>Anxiety Disorders - complications</topic><topic>Anxiety Disorders - drug therapy</topic><topic>Anxiety Disorders - epidemiology</topic><topic>Comorbidity</topic><topic>daridorexant</topic><topic>depression</topic><topic>dual orexin receptor antagonist</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>insomnia</topic><topic>insomnia therapy</topic><topic>Male</topic><topic>Mental Disorders - complications</topic><topic>Mental Disorders - drug therapy</topic><topic>Mental Disorders - epidemiology</topic><topic>Middle Aged</topic><topic>Orexin Receptor Antagonists - pharmacology</topic><topic>Orexin Receptor Antagonists - therapeutic use</topic><topic>Psychiatric Status Rating Scales</topic><topic>Severity of Illness Index</topic><topic>Sleep Initiation and Maintenance Disorders - drug therapy</topic><topic>Suicidal Ideation</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Palagini, Laura</creatorcontrib><creatorcontrib>Alfi, Gaspare</creatorcontrib><creatorcontrib>Gurrieri, Riccardo</creatorcontrib><creatorcontrib>Annuzzi, Eric</creatorcontrib><creatorcontrib>Caruso, Valerio</creatorcontrib><creatorcontrib>Gambini, Matteo</creatorcontrib><creatorcontrib>Grenno, Giovanna</creatorcontrib><creatorcontrib>Trivella, Marco</creatorcontrib><creatorcontrib>Presta, Silvio</creatorcontrib><creatorcontrib>Miniati, Mario</creatorcontrib><creatorcontrib>Pini, Stefano</creatorcontrib><creatorcontrib>Perugi, Giulio</creatorcontrib><creatorcontrib>Gemignani, Angelo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of sleep research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Palagini, Laura</au><au>Alfi, Gaspare</au><au>Gurrieri, Riccardo</au><au>Annuzzi, Eric</au><au>Caruso, Valerio</au><au>Gambini, Matteo</au><au>Grenno, Giovanna</au><au>Trivella, Marco</au><au>Presta, Silvio</au><au>Miniati, Mario</au><au>Pini, Stefano</au><au>Perugi, Giulio</au><au>Gemignani, Angelo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Early experience with the new DORA daridorexant in patients with insomnia disorder and comorbid mental disturbances: Results of a naturalistic study with 3 months follow‐up</atitle><jtitle>Journal of sleep research</jtitle><addtitle>J Sleep Res</addtitle><date>2024-12</date><risdate>2024</risdate><volume>33</volume><issue>6</issue><spage>e14196</spage><epage>n/a</epage><pages>e14196-n/a</pages><issn>0962-1105</issn><issn>1365-2869</issn><eissn>1365-2869</eissn><abstract><![CDATA[Summary
Insomnia disorder may affect mental health, increasing suicidal risk. Targeting insomnia is crucial in the clinical practice. Sixty‐six consecutive patients with insomnia disorder according with the DSM‐5‐TR criteria were treated with the dual orexin receptor antagonist, daridorexant 50 mg. Baseline (T0), 1 month (T1) and 3 month (T2) evaluations were performed. Insomnia severity (Insomnia Severity Index), mood, anxiety symptoms and suicidal risk (Beck Depression Inventory‐II, Young Mania Rating Scale, Self‐Reported Anxiety Scale, Suicidal Ideation Scale), dysfunctional insomnia‐cognitive factors and pre‐sleep arousal (Dysfunctional Beliefs About Sleep, Pre‐Sleep Arousal Scale) were evaluated. The final sample included 66 patients (n = 36, 54% females, mean age 60 ± 13.6 years). Most of them, 64%, suffered from insomnia disorder comorbid with unipolar/bipolar depression, anxiety disorders and substance use disorders. Repeated ANOVA analyses showed that Insomnia Severity Index, Dysfunctional Beliefs About Sleep and Pre‐Sleep Arousal Scale total score decreased across time (F = 68.818, p < 0.001; F = 47.561, p < 0.001; F = 28.142, p < 0.001, respectively). Similarly, Beck Depression Inventory‐II, Self‐Reported Anxiety Scale, Young Mania Rating Scale, and Suicidal Ideation Scale significantly decreased over time (p < 0.001). Predictors of insomnia remission (Insomnia Severity Index < 8) at T1 were improvement of Insomnia Severity Index at T1 (F = 60.205, p < 0.001), and improvement of Dysfunctional Beliefs About Sleep at T1 (F = 4.432, p = 0.041). Insomnia remission at T2 was best predicted by improvement of Dysfunctional Beliefs About Sleep at T2 (F = 3.993, p = 0.023). Multiple‐regression models showed that clinical improvement of Beck Depression Inventory‐II was best predicted by improvement in Dysfunctional Beliefs About Sleep at T1 and T2, manic symptoms by Insomnia Severity Index at T2, anxiety symptoms by Dysfunctional Beliefs About Sleep, Insomnia Severity Index and somatic Pre‐Sleep Arousal Scale at T1 and T2. With the caution of a naturalistic design, early experience with daridorexant showed that by targeting insomnia it may be possible to improve not only insomnia symptoms but also comorbid symptoms.]]></abstract><cop>England</cop><pmid>38522432</pmid><doi>10.1111/jsr.14196</doi><tpages>11</tpages></addata></record> |
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| subjects | Adult Aged anxiety Anxiety - drug therapy Anxiety Disorders - complications Anxiety Disorders - drug therapy Anxiety Disorders - epidemiology Comorbidity daridorexant depression dual orexin receptor antagonist Female Follow-Up Studies Humans insomnia insomnia therapy Male Mental Disorders - complications Mental Disorders - drug therapy Mental Disorders - epidemiology Middle Aged Orexin Receptor Antagonists - pharmacology Orexin Receptor Antagonists - therapeutic use Psychiatric Status Rating Scales Severity of Illness Index Sleep Initiation and Maintenance Disorders - drug therapy Suicidal Ideation Treatment Outcome |
| title | Early experience with the new DORA daridorexant in patients with insomnia disorder and comorbid mental disturbances: Results of a naturalistic study with 3 months follow‐up |
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