MEDICAL USE OF DARIDOREXANT
The invention relates to daridorexant: Formula (I) or drochloric acid salt; for use in a method of treatment of sleep disorders such as especially insomnias, wherein daridorexant improves daytime performance, especially reduces daytime sleepiness associated to such sleep disorder
1 . A method of treating a sleep disorder; said method comprising administering to a subject in need thereof an effective amount of daridorexant:
in free or pharmaceutically acceptable salt form;
wherein daridorexant improves the daytime performance of said subject.
2 . The method according to claim 1 , wherein said improvement of daytime performance of said subject is assessed by at least one of:
the IDSIQ daytime alert/cognition domain score; and/or
the IDSIQ daytime mood domain score, and/or
the IDSIQ daytime sleepiness domain score.
3 . A method of treating a sleep disorder; said method comprising administering to a subject in need thereof an effective amount of daridorexant in free or pharmaceutically acceptable salt form; wherein daridorexant reduces daytime clinical manifestations associated with said sleep disorder.
4 . The method according to claim 3 , wherein said daytime clinical manifestations associated with said sleep disorder are symptoms of daytime sleepiness, especially as assessed by the IDSIQ daytime sleepiness domain score.
5 . The method according to claim 1 , wherein said improvement of daytime performance is expressed by subjects to whom daridorexant has been administered, wherein said subjects feel, cumulatively, less physically tired, less mentally tired, less sleepy and more energetic during the day.
6 . The method according to claim 1 , wherein said sleep disorder is a dyssomnia or a sleep disorder associated with a general medical condition.
7 . The method according to claim 1 , wherein said sleep disorder is an insomnia.
8 . The method according to claim 1 , wherein said treatment of said sleep disorder results in at least one, preferably all of the following treatment effects:
a decrease in latency to persistent sleep (LPS); and/or
a decrease in wake time after sleep onset (WASO); and/or
an increase in total sleep time subjectively (sTST) assessed daily by the patient.
9 . The method according to claim 1 , wherein said subject has been diagnosed as having difficulties with sleep onset and/or sleep maintenance.
10 . The method according to claim 1 , wherein daridorexant in free or pharmaceutically acceptable salt form, is administered in a unit dose of about 25 mg of daridorexant, or in a unit dose of about 50 mg of daridorexant.
11 . The method according to claim 1 , wherein the daridorexant is in hydrochloric acid salt form.
12 . The method according to claim 1 , wherein daridorexant in free or pharmaceutically acceptable salt form is administered in form of a tablet; wherein said tablet is a film coated tablet comprising
a tablet core; said tablet core comprising at least two, preferably all of the following excipients: mannitol, microcrystalline cellulose, povidone, croscarmellose sodium, silicon dioxide, and/or magnesium stearate; and
a film coat; said film coat comprising at least two, preferably all of the following excipients: hypromellose, microcrystalline cellulose, glycerine, talc, titanium dioxide, and/or iron oxide.
13 . The method according to claim 1 , wherein daridorexant in free or pharmaceutically acceptable salt form is administered once daily within 1 h before bedtime, in particular within 30 min before bedtime.
14 . The method according to claim 1 , wherein said sleep disorder is a chronic sleep disorder.
15 . A method of treating daytime sleepiness in a subject, comprising administering to said subject an effective amount of daridorexant in free or pharmaceutically acceptable salt form, wherein said subject has a reduction in daytime sleepiness as assessed by the IDSIQ daytime sleepiness domain score; wherein especially said subject has been diagnosed as having a sleep disorder.
16 . A method of treating insomnia to improve sleep and daytime functioning, comprising administering to a subject in need thereof an effective amount of daridorexant in free or pharmaceutically acceptable salt form, wherein notably said subject has a reduction in daytime sleepiness as assessed by the IDSIQ daytime sleepiness domain score.
17 . (canceled)
18 . The method according to claim 3 , wherein said reduction of daytime clinical manifestations associated with said sleep disorder is expressed by subjects to whom daridorexant has been administered, wherein said subjects feel, cumulatively, less physically tired, less mentally tired, less sleepy and more energetic during the day.
19 . The method according to claim 3 , wherein said sleep disorder is a dyssomnia or a sleep disorder associated with a general medical condition.
20 . The method according to claim 3 , wherein said sleep disorder is an insomnia.
21 . The method according to claim 3 , wherein said treatment of said sleep disorder results in at least one, preferably all of the following treatment effects:
a decrease in latency to persistent sleep (LPS); and/or
a decrease in wake time after sleep onset (WASO); and/or
an increase in total sleep time subjectively (sTST) assessed daily by the patient.
22 . The method according to claim 3 , wherein said subject has been diagnosed as having difficulties with sleep onset and/or sleep maintenance.
23 . The method according to claim 3 , wherein daridorexant in free or pharmaceutically acceptable salt form, is administered in a unit dose of about 25 mg of daridorexant, or in a unit dose of about 50 mg of daridorexant.
24 . The method according to claim 3 , wherein the daridorexant is in hydrochloric acid salt form.
25 . The method according to claim 3 , wherein daridorexant in free or pharmaceutically acceptable salt form is administered in form of a tablet; wherein said tablet is a film coated tablet comprising
a tablet core; said tablet core comprising at least two, preferably all of the following excipients: mannitol, microcrystalline cellulose, povidone, croscarmellose sodium, silicon dioxide, and/or magnesium stearate; and
a film coat; said film coat comprising at least two, preferably all of the following excipients: hypromellose, microcrystalline cellulose, glycerine, talc, titanium dioxide, and/or iron oxide.
26 . The method according to claim 3 , wherein daridorexant in free or pharmaceutically acceptable salt form is administered once daily within 1 h before bedtime, in particular within 30 min before bedtime.
27 . The method according to claim 3 , wherein said sleep disorder is a chronic sleep disorder.