IP Library › Granted Patent US 12,427,132
Granted Patent B2
US 12,427,132 · App. 17/820,025 · Granted Sep 30, 2025

Method of improving sleep

Inventors: Mihael Polymeropoulos (Potomac, MD); Sandra Smieszek (Washington, DC)
Assignee: VANDA PHARMACEUTICALS INC.
A61K31/343C12Q1/6883C12Q2600/106C12Q2600/156
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Quick Facts
Patent No.
US 12,427,132
App. No.
17/820,025
Granted
Sep 30, 2025
Kind
B2
Abstract

The invention provides methods of improving sleep in a patient having a variant of the cryptochrome circadian clock 1 (CRY1) genotype associated with a circadian rhythm sleep disorder (CRSD) Delayed Sleep Wake Phase Disorder (DSWPD).

Claims (15)

1. In a method of treating patients with tasimelteon, the improvement comprising:

selecting a patient for said treatment who has delayed sleep wake phase disorder (DSWPD) and at least one copy of the rs112474322 allele.

2. The improvement of claim 1 , wherein treating the patient includes administering tasimelteon to the patient once daily before bedtime.

3. The improvement of claim 2 , wherein administering tasimelteon to the patient includes administering 20 mg of tasimelteon.

4. 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).

5. A method for treating a patient exhibiting one or more symptoms of delayed sleep wake phase disorder (DSWPD), which comprises:

identifying that said patient has at least one copy of the rs112474322 allele; and

administering an amount of tasimelteon to said patient effective to treat said one or more symptoms.

6. The method of claim 5 , wherein the amount of tasimelteon is 20 mg.

7. The method of claim 5 , wherein treating said one or more symptoms 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).

8. A method for improving one or more sleep parameters in an individual suffering from delayed sleep wake phase disorder (DSWPD), the method comprising:

identifying that said individual has at least one copy of the rs112474322 allele; 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.

9. The method of claim 8 , wherein the amount of tasimelteon is 20 mg.

10. The method of claim 8 , wherein the one or more sleep parameters is 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).

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 17, 2022
From: POLYMEROPOULOS, MIHAEL; SMIESZEK, SANDRA
To: VANDA PHARMACEUTICALS INC.
Reel/Frame 060830/0246 →
Continuity (3)
Division 17429614
Provisional Application 62805057 · Feb 13, 2019
Related Publication 20220387374A1 · Dec 8, 2022
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