Method of improving sleep
The invention provides methods of improving sleep in a patient having a variant of the cryptochrome circadian clock 1 (CRY 1) genotype associated with a circadian rhythm sleep disorder (CRSD) Delayed Sleep Wake Phase Disorder (DSWPD).
1. In a method of treating patients with a circadian rhythm sleep disorder (CRSD) consisting essentially of administering to said patients an amount of tasimelteon effective to treat said disorder, the improvement comprising:
selecting a patient for said treatment by identifying that said patient has a cryptochrome circadian clock 1 (CRY1) genotype associated with said disorder.
2. The improvement of claim 1 , wherein the CRY1 genotype associated with said disorder includes at least one copy of the rs184039278 allele.
3. The improvement of claim 1 , wherein the CRY1 genotype associated with said disorder includes at least one copy of the rs780614131 allele.
4. The improvement of claim 1 , wherein the CRY1 genotype associated with said disorder is a loss-of-function (LOF) genotype.
5. The improvement of claim 1 , wherein said disorder is delayed sleep wake phase disorder (DSWPD).
6. The improvement of claim 1 , wherein treating the patient includes administering tasimelteon to the patient once daily before bedtime.
7. The improvement of claim 6 , wherein administering tasimelteon to the patient includes administering 20 mg of tasimelteon.
8. The improvement of claim 1 , wherein treating the patient with tasimelteon improves at least one sleep parameter selected from a group consisting of: latency to persistent sleep (LPS); sleep efficiency (%) during the first, second, and/or final thirds of the night; rapid eye movement (REM) sleep duration; total sleep time (TST), including during the first two-thirds of the night; and wake after persistent sleep (WASO).
9. A method for treating a patient exhibiting one or more symptoms of a circadian rhythm sleep disorder, which comprises:
identifying that said patient has a cryptochrome circadian clock 1 (CRY1) genotype associated with said disorder, and
administering an amount of tasimelteon to said patient effective to treat said disorder.
10. The method of claim 9 , wherein the CRY1 genotype associated with said disorder includes at least one copy of the rs184039278 allele.
11. The method of claim 9 , wherein the CRY1 genotype associated with said disorder includes at least one copy of the rs780614131 allele.
12. The method of claim 9 , wherein the cRY1 genotype is a loss-of-function (LOF) genotype.
13. The method of claim 9 , wherein said disorder is delayed sleep wake phase disorder (DSWPD).
14. The method of claim 9 , wherein the amount of tasimelteon is 20 mg.
15. The method of claim 9 , wherein treating said disorder includes improving at least one sleep parameter selected from a group consisting of: latency to persistent sleep (LPS); sleep efficiency (%) during the first, second, and/or final thirds of the night; rapid eye movement (REM) sleep duration; total sleep time (TST), including during the first two-thirds of the night; and wake after persistent sleep (WASO).
16. A method for improving one or more sleep parameters in an individual, the method comprising:
identifying that said individual possesses a variant of the cryptochrome circadian clock 1 (CRY1) genotype associated with a circadian rhythm sleep disorder (CRSD); and
administering to said individual daily, at a time proximately before the individual's established bedtime, an amount of tasimelteon effective to improve one or more sleep parameters in said individual.
17. The method of claim 16 , wherein the variant of the CRY1 genotype associated with a CRSD is the rs184039278 allele.
18. The method of claim 16 , wherein the variant of the CRY1 genotype associated with the CRSD includes the rs780614131 allele.
19. The method of claim 16 , wherein the variant of the CRY1 genotype associated with the CRSD is a loss-of-function (LOF) genotype.
20. The method of claim 16 , wherein the CRSD is delayed sleep wake phase disorder (DSWPD).
21. The method of claim 16 , wherein the amount of tasimelteon is 20 mg.
22. The method of claim 16 , wherein improving sleep includes improving at least one sleep parameter selected from a group consisting of: latency to persistent sleep (LPS); sleep efficiency (%) during the first, second, and/or final thirds of the night; rapid eye movement (REM) sleep duration; total sleep time (TST), including during the first two-thirds of the night; and wake after persistent sleep (WASO).