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viduals 2 however the half life of suvorexant at a dose of 20 mg was prolonged from 14 7 hours range 10 22 hours to 19 1 hours range 11 49 hours in these individuals 2 7 suvorexant exposure is unchanged in people with severe renal impairment and no dosage adjustment is necessary in these individuals 2 similarly to hepatic impairment the half life of suvorexant was increased to 19 4 hours when used in combination with the strong cyp3a4 inhibitor ketoconazole and to 16 1 hours with the moderate cyp3a4 inhibitor diltiazem while it was decreased to 7 7 hours with the strong cyp3a4 inducer rifampin 55 54 miscellaneous edit peak normalized semi log concentrations of c max of the orexin receptor antagonists suvorexant lemborexant daridorexant and seltorexant with administration in humans 14 the terminal elimination half lives in these studies were 12 hours 55 hours 6 hours and 2 5 hours respectively 14 peak normalized concentrations of c max of the orexin receptor antagonists suvorexant suv 20 mg and lemborexant lem 10 mg with administration at steady state in humans 73 the delayed time to peak levels 2 3 hours and long elimination half life 12 hours of suvorexant are less than ideal for an insomnia medication as they result in a delayed onset of effect and significant next day side effects such as daytime sedation 6 9 orexin receptor antagonists with shorter half lives and faster onsets of action are theoretically more optimal for therapeutic use as sleep aids 6 14 the ideal insomnia medication would not have a duration of action extending beyond about 8 hours 53 relative to suvorexant daridorexant has a shorter half life 8 hours while lemborexant has a longer half life 17 55 hours 14 however although lemborexant has a longer terminal elimination half life than suvorexant it appears to be more rapidly cleared in the earlier phases of elimination 73 14 the investigational agents seltorexant and vornorexant which are still in clinical trials have comparatively very short half lives in the range of 1 5 to 3 hours 14 74 chemistry edit suvorexant is a small molecule compound 75 the chemical name of suvorexant is 7 r 4 5 chloro 2 benzoxazolyl hexahydro 7 methyl 1 h 1 4 diazepin 1 yl 5 methyl 2 2 h 1 2 3 triazol 2 yl phenyl methanone 2 its molecular formula is c 23 h 23 n 6 o 2 cl and its molecular weight is 450 92 g mol 2 suvorexant is a white to off white powder and is lipophilic and insoluble in water 2 14 it is structurally related to other orexin receptor antagonists like lemborexant daridorexant and seltorexant 14 75 history edit the orexin neuropeptides were discovered in 1998 22 16 and the role of the orexin system in the etiology of narcolepsy was identified between 1999 and 2000 70 subsequent research further established the role of the orexin system in sleep wake regulation 22 16 64 due to the promising potential of orexin system modulation in the treatment of sleep disorders these findings led to translational efforts to bring orexin receptor modulators to medicine as therapeutic agents 22 16 64 70 69 suvorexant was developed by merck 22 16 it entered clinical development in 2006 16 and was first described in the medical literature in 2010 76 the medication was approved by the fda for the treatment of insomnia in the united states on 13 august 2014 2 11 77 suvorexant was initially released november 2014 in japan 17 then later reached the united states in february 2015 78 australia in november 2016 and canada in november 2018 79 it was the first orexin receptor antagonist to be introduced for medical use and was followed by lemborexant in 2019 and daridorexant in 2022 57 14 23 development of almorexant act 078573 and filorexant mk 6096 was discontinued while seltorexant min 202 jnj 42847922 and vornorexant orn 0829 ts 142 are still in clinical trials 14 22 suvorexant marketing exclusivity in the united states was set to expire in january 2023 and patent protection is set to expire in 2029 to 2033 11 society and culture edit names edit suvorexant is the generic name of the drug and its inn tooltip international nonproprietary name usan tooltip united states adopted name and jan tooltip japanese accepted name 80 81 the medication was developed by merck under the code name mk 4305 and is marketed under the brand name belsomra 34 availability edit suvorexant has been marketed in the united states canada australia russia and japan 82 78 79 17 although previously available suvorexant appears to have been discontinued in canada 83 82 it does not appear to be available in the united kingdom or other european countries besides russia 84 85 82 legal status edit suvorexant is a schedule iv controlled substance under the controlled substances act in the united states 18 86 87 it is not a controlled drug in australia instead being classed as a prescription only medicine schedule 4 s4 in this country 1 controversy edit public citizen a progressive consumer rights advocacy group issued a letter in june 2013 urging the fda not to approve suvorexant 25 in its reasoning it cited marginal benefits and excessive potential for harm including next day effects like driving impairment and possible accidents 25 consumer reports also published articles encouraging consumers to avoid suvorexant due to it being expensive having limited effectiveness and posing safety concerns 88 89 research edit delirium edit suvorexant is under development for the treatment of delirium 90 as of october 2021 it is in phase iii clinical trials for this indication 90 psychiatry edit suvorexant has been studied in the treatment of insomnia in people with psychiatric disorders such as depression and anxiety 30 91 92 it was reported to improve psychiatric symptoms and to decrease cortisol levels in these individuals 91 30 a phase iv clinical trial of suvorexant as an adjunct to antidepressant therapy in people with major depressive disorder and residual insomnia was underway as of 2019 30 93 although orexin receptor antagonists including suvorexant could be useful for treatment of depression and anxiety there is also indication that they could have harmful effects in these conditions e g animal studies and suicidal ideation in clinical trials 40 46 59 more clinical research is needed to determine the place of orexin receptor antagonists in the treatment of people with depression and anxiety 40 there is interest in suvorexant and other orexin receptor antagonists in the potential treatment of substance use disorders 94 95 44 46 53 22 92 including alcohol use disorder 96 97 98 cocaine use disorder 58 and opioid use disorder 99 alzheimer s disease edit suvorexant and other orexin receptor modulators are of interest for possible use in the prevention of alzheimer s disease 92 100 diabetes edit suvorexant has been studied in people with type 2 diabetes and insomnia and has been reported to improve sleep and metabolic parameters in these individuals 101 102 the improvement in metabolic parameters appeared to be related to improved sleep 101 102 references edit 1 2 3 4 5 belsomra suvorexant australian product information 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 belsomra suvorexant tablet film coated dailymed retrieved 30 january 2020 prescription medicines registration of new chemical entities in australia 2016 therapeutic goods administration tga 21 june 2022 retrieved 10 april 2023 regulatory decision summary for belsomra 23 october 2014 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 merck sharp and dohme corporation 22 may 2013 suvorexant advisory committee meeting briefing document peripheral central nervous system drugs advisory committee meeting pdf food and drug administration archived from the original pdf on 12 june 2013 retrieved 14 april 2022 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 jacobson lh callander ge hoyer d november 2014 suvorexant for the treatment of insomnia expert review of clinical pharmacology 7 6 711 730 doi 10 1586 17512433 2014 966813 pmid 25318834 s2cid 41099462 1 2 3 4 5 6 7 8 9 10 dimova h brar s men a 2014 application number 204569orig1s000 clinical pharmacology biopharmaceutics review suvorexant mk 4305 pdf center for drug evaluation and research food and drug administration archived from the original pdf on 5 march 2022 1 2 3 4 5 6 7 8 9 kuriyama a tabata h october 2017 suvorexant for the treatment of primary insomnia a systematic review and meta analysis sleep medicine reviews 35 1 7 doi 10 1016 j smrv 2016 09 004 pmid 28365447 1 2 3 4 5 6 7 8 9 10 11 12 sutton el 2015 profile of suvorexant in the management of insomnia drug design development and therapy 9 6035 6042 doi 10 2147 dddt s73224 pmc 4651361 pmid 26648692 1 2 3 4 de crescenzo f d alò gl ostinelli eg ciabattini m di franco v watanabe n et al july 2022 comparative effects of pharmacological interventions for the acute and long term management of insomnia disorder in adults a systematic review and network meta analysis lancet 400 10347 170 184 doi 10 1016 s0140 6736 22 00878 9 hdl 11380 1288245 pmid 35843245 s2cid 250536370 1 2 3 4 5 6 belsomra generic belsomra availability drugs com 1 2 kishi t matsunaga s iwata n 2015 suvorexant for primary insomnia a systematic review and meta analysis of randomized placebo controlled trials plos one 10 8 e0136910 bibcode 2015ploso 1036910k doi 10 1371 journal pone 0136910 pmc 4552781 pmid 26317363 1 2 3 4 keks na hope j keogh s december 2017 suvorexant scientifically interesting utility uncertain australasian psychiatry 25 6 622 624 doi 10 1177 1039856217734677 pmid 28994603 s2cid 206620990 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 muehlan c vaillant c zenklusen i kraehenbuehl s dingemanse j november 2020 clinical pharmacology efficacy and safety of orexin receptor antagonists for the treatment of insomnia disorders expert opinion on drug metabolism toxicology 16 11 1063 1078 doi 10 1080 17425255 2020 1817380 pmid 32901578 s2cid 221572078 1 2 atkin t comai s gobbi g april 2018 drugs for insomnia beyond benzodiazepines pharmacology clinical applications and discovery pharmacological reviews 70 2 197 245 doi 10 1124 pr 117 014381 pmid 29487083 s2cid 3578916 1 2 3 4 5 6 preskorn sh november 2014 cns drug development lessons from the development of ondansetron aprepitant ramelteon varenicline lorcaserin and suvorexant part i journal of psychiatric practice 20 6 460 465 doi 10 1097 01 pra 0000456594 66363 6f pmid 25406050 s2cid 35086648 1 2 3 new hypnotic drug without addiction to be released in japan first retrieved 6 november 2014 cite web cs1 maint deprecated archival service link 1 2 schedules of controlled substances placement of suvorexant into schedule iv federalregister gov federal register 13 february 2014 retrieved 10 august 2016 a proposed rule by the drug enforcement administration on 02 13 2014 1 2 3 4 5 6 7 8 9 10 citrome l december 2014 suvorexant for insomnia a systematic review of the efficacy and safety profile for this newly approved hypnotic what is the number needed to treat number needed to harm and likelihood to be helped or harmed international journal of clinical practice 68 12 1429 1441 doi 10 1111 ijcp 12568 pmid 25231363 s2cid 20955172 1 2 janto k prichard jr pusalavidyasagar s august 2018 an update on dual orexin receptor antagonists and their potential role in insomnia therapeutics journal of clinical sleep medicine 14 8 1399 1408 doi 10 5664 jcsm 7282 pmc 6086961 pmid 30092886 1 2 lee iannotti jk parish jm 2016 suvorexant a promising novel treatment for insomnia neuropsychiatric disease and treatment 12 491 495 doi 10 2147 ndt s31495 pmc 4772996 pmid 26955275 1 2 3 4 5 6 7 8 9 10 11 12 13 jacobson lh hoyer d de lecea l may 2022 hypocretins orexins the ultimate translational neuropeptides journal of internal medicine 291 5 533 556 doi 10 1111 joim 13406 pmid 35043499 s2cid 248119793 1 2 markham a april 2022 daridorexant first approval drugs 82 5 601 607 doi 10 1007 s40265 022 01699 y pmc 9042981 pmid 35298826 s2cid 247501311 1 2 3 4 5 6 7 kripke df 2015 is suvorexant a better choice than alternative hypnotics f1000research 4 456 doi 10 12688 f1000research 6845 1 pmc 4648222 pmid 26594338 1 2 3 4 5 6 7 letter to the fda opposing approval of the sleep medicine suvorexant public citizen inc 14 june 2013 1 2 wang l pan y ye c guo l luo s dai s et al december 2021 a network meta analysis of the long and short term efficacy of sleep medicines in adults and older adults neuroscience and biobehavioral reviews 131 489 496 doi 10 1016 j neubiorev 2021 09 035 pmid 34560134 s2cid 237589779 mcelroy h o leary b adena m campbell r monfared aa meier g september 2021 comparative efficacy of lemborexant and other insomnia treatments a network meta analysis journal of managed care specialty pharmacy 27 9 1296 1308 doi 10 18553 jmcp 2021 21011 pmc 10394202 pmid 34121443 xue t wu x chen s yang y yan z song z et al february 2022 the efficacy and safety of dual orexin receptor antagonists in primary insomnia a systematic review and network meta analysis sleep medicine reviews 61 101573 doi 10 1016 j smrv 2021 101573 pmid 34902823 s2cid 244689706 clark jw brian ml drummond sp hoyer d jacobson lh october 2020 effects of orexin receptor antagonism on human sleep architecture a systematic review sleep medicine reviews 53 101332 doi 10 1016 j smrv 2020 101332 pmid 32505969 s2cid 219407655 1 2 3 4 5 6 7 shariq as rosenblat jd alageel a mansur rb rong c ho rc et al june 2019 evaluating the role of orexins in the pathophysiology and treatment of depression a comprehensive review progress in neuro psychopharmacology biological psychiatry 92 1 7 doi 10 1016 j pnpbp 2018 12 008 pmid 30576764 s2cid 56482209 1 2 pałasz a lapray d peyron c rojczyk gołębiewska e skowronek r markowski g et al january 2014 dual orexin receptor antagonists promising agents in the treatment of sleep disorders the international journal of neuropsychopharmacology 17 1 157 168 doi 10 1017 s1461145713000552 pmid 23702225 berger aa sottosanti er winnick a keefe j gilbert e hasoon j et al february 2022 suvorexant in the treatment of difficulty falling and staying asleep insomnia psychopharmacology bulletin 52 1 68 90 doi 10 64719 pb 4429 pmc 8896749 pmid 35342199 herring wj roth t krystal ad michelson d april 2019 orexin receptor antagonists for the treatment of insomnia and potential treatment of other neuropsychiatric indications journal of sleep research 28 2 e12782 doi 10 1111 jsr 12782 pmid 30338596 s2cid 53019189 1 2 3 4 5 6 7 patel kv aspesi av evoy ke april 2015 suvorexant a dual orexin receptor antagonist for the treatment of sleep onset and sleep maintenance insomnia the annals of pharmacotherapy 49 4 477 483 do...