Treatment of sleep disorders

Abstract

The use of 7-chloro-3-(5-dimethylaminomethyl-[1,2,4]oxadiazol-3-yl)-5methyl 4,5-dihydro-imidazol[1,5,-a][1,4]benzodiazepine-6-one or its pharmaceutically acceptable salt for treating various types of insomnia.

1 - 35 . (canceled) 
   
   
       36 . A method for treating maintenance insomnia in a human in need thereof comprising administering to the human an amount of a compound of formula (II) or a pharmaceutically acceptable salt thereof effective to treat the maintenance insomnia 
     
       
         
         
             
             
         
       
     
   
   
       37 . The method according to  claim 36 , wherein the amount of the compound of formula (II) is from about 0.5 mg to about 5 mg. 
   
   
       38 . The method according to  claim 36 , wherein the amount of the compound of formula (II) is from about 1 mg to about 3 mg. 
   
   
       39 . The method according to  claim 36 , wherein the amount of the compound of formula (II) is from about 1.5 mg to about 2.5 mg. 
   
   
       40 . The method according to  claim 36 , which is also for treatment of sleep onset insomnia, comprising administering to a human in need of such treatment an amount of the compound of formula (II) or the pharmaceutically acceptable salt thereof also effective to treat the sleep onset insomnia. 
   
   
       41 . The method according to  claim 36 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to reduce latency to sleep onset and/or latency to persistent sleep. 
   
   
       42 . The method according to  claim 36 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to achieve a maximal potentiation of a response mediated by GABA A  receptors containing an α 1 -subunit of from about 40% to about 90%. 
   
   
       43 . The method according to  claim 36 , wherein the human is at least 65 years old. 
   
   
       44 . A method for decreasing wake after sleep onset in a human in need thereof comprising administering to the human an amount of a compound of formula (II) or a pharmaceutically acceptable salt thereof effective to decrease the wake after sleep onset 
     
       
         
         
             
             
         
       
     
   
   
       45 . The method according to  claim 44 , wherein the amount of the compound of formula (II) is from about 0.5 mg to about 5 mg. 
   
   
       46 . The method according to  claim 44 , wherein the amount of the compound of formula (II) is from about 1 mg to about 3 mg. 
   
   
       47 . The method according to  claim 44 , wherein the amount of the compound of formula (II) is from about 1.5 mg to about 2.5 mg. 
   
   
       48 . The method according to  claim 44 , which is also for treatment of sleep onset insomnia, comprising administering to a human in need of such treatment an amount of the compound of formula (II) or the pharmaceutically acceptable salt thereof also effective to treat the sleep onset insomnia. 
   
   
       49 . The method according to  claim 44 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to reduce latency to sleep onset and/or latency to persistent sleep. 
   
   
       50 . The method according to  claim 44 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to achieve a maximal potentiation of a response mediated by GABA A  receptors containing an α 1 -subunit of from about 40% to about 90%. 
   
   
       51 . The method according to  claim 44 , wherein the human is at least 65 years old. 
   
   
       52 . The method according to  claim 44 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to decrease the wake after sleep onset in a period from about four to about eight hours after administration. 
   
   
       53 . The method according to  claim 52 , wherein the period is from about five to about eight hours after administration. 
   
   
       54 . The method according to  claim 52 , wherein the period is from about six to about eight hours after administration. 
   
   
       55 . A method for treating terminal insomnia in a human in need thereof comprising administering to the human an amount of a compound of formula (II) or a pharmaceutically acceptable salt thereof effective to treat the terminal insomnia 
     
       
         
         
             
             
         
       
     
   
   
       56 . The method according to  claim 55 , wherein the amount of the compound of formula (II) is from about 0.5 mg to about 5 mg. 
   
   
       57 . The method according to  claim 55 , wherein the amount of the compound of formula (II) is from about 1 mg to about 3 mg. 
   
   
       58 . The method according to  claim 55 , wherein the amount of the compound of formula (II) is from about 1.5 mg to about 2.5 mg. 
   
   
       59 . The method according to  claim 55 , which is also for treatment of sleep onset and/or maintenance insomnia, comprising administering to a human in need of such treatment an amount of the compound of formula (II) or the pharmaceutically acceptable salt thereof also effective to treat the sleep onset insomnia and/or the maintenance insomnia. 
   
   
       60 . The method according to  claim 55 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to reduce latency to sleep onset, latency to persistent sleep and/or wake after sleep onset. 
   
   
       61 . The method according to  claim 55 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to achieve a maximal potentiation of a response mediated by GABA A  receptors containing an α 1 -subunit of from about 40% to about 90%. 
   
   
       62 . The method according to  claim 55 , wherein the human is at least 65 years old. 
   
   
       63 . A method for increasing total sleep time in a period in a human in need thereof comprising administering to the human an amount of a compound of formula (II) or a pharmaceutically acceptable salt thereof effective to increase total sleep time in the period, which is about four to about eight hours after administration 
     
       
         
         
             
             
         
       
     
   
   
       64 . The method according to  claim 63 , wherein the amount of the compound of formula (II) is from about 0.5 mg to about 5 mg. 
   
   
       65 . The method according to  claim 63 , wherein the amount of the compound of formula (II) is from about 1 mg to about 3 mg. 
   
   
       66 . The method according to  claim 63 , wherein the amount of the compound of formula (II) is from about 1.5 mg to about 2.5 mg. 
   
   
       67 . The method according to  claim 63 , which is also for treatment of sleep onset insomnia, comprising administering to a human in need of such treatment an amount of the compound of formula (II) or the pharmaceutically acceptable salt thereof also effective to treat the sleep onset insomnia. 
   
   
       68 . The method according to  claim 63 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to reduce latency to sleep onset, latency to persistent sleep and/or wake after sleep onset. 
   
   
       69 . The method according to  claim 63 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to achieve a maximal potentiation of a response mediated by GABA A  receptors containing an α 1 -subunit of from about 40% to about 90%. 
   
   
       70 . The method according to  claim 63 , wherein the human is at least 65 years old. 
   
   
       71 . The method according to  claim 63 , wherein the period is from about five to about eight hours after administration. 
   
   
       72 . The method according to  claim 63 , wherein the period is from about six to about eight hours after administration. 
   
   
       73 . A method for treating maintenance and/or terminal insomnia in a human in need thereof comprising administering to the human a compound of formula (II) or a pharmaceutically acceptable salt thereof to achieve an AUC from about 17.5 ng·h/mL to about 600 ng·h/mL and a C max  from about 2.5 ng/mL to about 125 ng/mL 
     
       
         
         
             
             
         
       
     
   
   
       74 . The method according to  claim 73 , wherein the AUC is from about 50 ng·h/mL to about 360 ng·h/mL. 
   
   
       75 . The method according to  claim 73 , wherein the AUC is from about 75 ng·h/mL to about 240 ng·h/mL. 
   
   
       76 . The method according to  claim 73 , wherein the C max  is from about 10 ng/mL to about 75 ng/mL. 
   
   
       77 . The method according to  claim 73 , wherein the C max  is from about 15 ng/mL to about 45 ng/mL. 
   
   
       78 . The method according to  claim 73 , which is also for treatment of sleep onset insomnia, comprising administering to a human in need of such treatment an amount of the compound of formula (II) or the pharmaceutically acceptable salt thereof also effective to treat the sleep onset insomnia. 
   
   
       79 . The method according to  claim 73 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to reduce latency to sleep onset, latency to persistent sleep and/or wake after sleep onset. 
   
   
       80 . The method according to  claim 73 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to achieve a maximal potentiation of a response mediated by GABA A  receptors containing an α 1 -subunit of from about 40% to about 90%. 
   
   
       81 . The method according to  claim 73 , wherein the human is at least 65 years old. 
   
   
       82 . A method for treating insomnia in a human in need thereof comprising administering to the human an amount of a compound of formula (II) or a pharmaceutically acceptable salt thereof effective to treat the insomnia 
     
       
         
         
             
             
         
       
       wherein the human is at least 65 years old. 
     
   
   
       83 . The method according to  claim 82 , wherein the amount of the compound of formula (II) is from about 0.5 mg to about 5 mg. 
   
   
       84 . The method according to  claim 82 , wherein the amount of the compound of formula (II) is from about 1 mg to about 3 mg. 
   
   
       85 . The method according to  claim 82 , wherein the amount of the compound of formula (II) is from about 1.5 mg to about 2.5 mg. 
   
   
       86 . The method according to  claim 82 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to reduce latency to sleep onset, latency to persistent sleep and/or wake after sleep onset. 
   
   
       87 . The method according to  claim 82 , wherein the administration of the compound of formula (II) or the pharmaceutically acceptable salt thereof is such as to achieve a maximal potentiation of a response mediated by GABA A  receptors containing an α 1 -subunit of from about 40% to about 90%.