Method of treatment

Patent metadata

Field	Value
Publication number	US-10653665-B2
Application number	US-201816211687-A
Country	US
Kind code	B2
Filing date	Dec 6, 2018
Priority date	Sep 2, 2014
Publication date	May 19, 2020
Grant date	May 19, 2020

Abstract

Embodiments of the invention relate to the treatment of sleep disturbances in individuals with Smith-Magenis Syndrome (SMS).

First claim

What is claimed is:

1. A method of treating a sleep disturbance in an individual suffering from Smith-Magenis Syndrome (SMS), the method comprising:
inhibiting melatonin production in the individual during waking hours by reducing exposure of the individual's eyes to light, administering to the individual an effective amount of a beta blocker, or both; and
administering to the individual an effective amount of tasimelteon once daily before bedtime.

2. The method of claim 1 , wherein inhibiting melatonin production includes reducing exposure of the individual's eyes to light.

3. The method of claim 2 , wherein reducing exposure of the individual's eyes to light includes the individual wearing light blocking eyewear.

4. The method of claim 2 , wherein reducing exposure of the individual's eyes to light includes the individual wearing light filtering eyewear.

5. The method of claim 1 , wherein inhibiting melatonin production includes administering to the individual an effective amount of a beta blocker.

6. The method of claim 1 , wherein the tasimelteon is administered at a dosage of between about 5 mg/day and about 100 mg/day.

7. The method of claim 6 , wherein the tasimelteon is administered at a dosage of between about 20 mg/day and about 50 mg/day.

8. The method of claim 7 , wherein the tasimelteon is administered at a dosage of about 20 mg/day.

9. The method of claim 1 , wherein the tasimelteon is administered between one-half hour and two hours prior to bedtime.

10. The method of claim 9 , wherein the tasimelteon is administered between one-half hour and one and one-half hours prior to bedtime.

11. The method of claim 10 , wherein the tasimelteon is administered about one hour prior to bedtime.

12. A method of regulating melatonin production in an individual exhibiting light-induced melatonin production, the method comprising:
inhibiting melatonin production in the individual during waking hours; and
stimulating melatonin production in the individual during sleep by administering to the individual an effective amount of tasimelteon once daily before bedtime.

13. The method of claim 12 , wherein inhibiting melatonin production includes reducing exposure of the individual's eyes to light by at least one of the following: the individual wearing light blocking eyewear, the individual wearing light filtering eyewear, or administering to the individual an effective amount of a beta blocker.

14. The method of claim 12 , wherein the tasimelteon is administered at a dosage of between about 5 mg/day and about 100 mg/day.

15. The method of claim 14 , wherein the tasimelteon is administered at a dosage of between about 20 mg/day and about 50 mg/day.

16. The method of claim 15 , wherein the tasimelteon is administered at a dosage of about 20 mg/day.

17. The method of claim 12 , wherein the tasimelteon is administered between one-half hour and two hours prior to bedtime.

18. The method of claim 17 , wherein the tasimelteon is administered between one-half hour and one and one-half hours prior to bedtime.

19. The method of claim 18 , wherein the tasimelteon is administered about one hour prior to bedtime.

20. A method of treating a sleep disturbance in an individual suffering from Smith-Magenis Syndrome (SMS), the method comprising:
inhibiting melatonin production in the individual during waking hours; and
stimulating melatonin production in the individual during sleep by exposing the individual's eyes to light.

Assignees

• Vanda Pharmaceuticals Inc

Inventors

• Lavedan Christian
• Polymeropoulos Mihael H

Classifications

• A61K31/343 Primary

  condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61P25/20

  Hypnotics; Sedatives · CPC title

• A61K31/00

  Medicinal preparations containing organic active ingredients · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title