Treatment of circadian rhythm disorders

Patent metadata

Field	Value
Publication number	US-10149829-B2
Application number	US-201615382526-A
Country	US
Kind code	B2
Filing date	Dec 16, 2016
Priority date	Jan 26, 2012
Publication date	Dec 11, 2018
Grant date	Dec 11, 2018

Abstract

Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.

First claim

What is claimed is:

1. A method of treating a patient for a circadian rhythm disorder or for a sleep disorder wherein the patient is being treated with a strong CYP1A2 inhibitor selected from a group consisting of fluvoxamine, ciprofloxacin, and verapamil, the method comprising:
(A) reducing the dose of the strong CYP1A2 inhibitor treatment and then
(B) treating the patient with tasimelteon,
wherein the exposure to tasimelteon in a patient being treated with tasimelteon for a circadian rhythm disorder or for a sleep disorder is reduced.

2. The method of claim 1 , wherein the CYP1A2 inhibitor is fluvoxamine.

3. The method of claim 2 , that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder.

4. The method of claim 3 , wherein the patient is light perception impaired (LPI).

5. The method of claim 3 , wherein treating the patient with tasimelteon comprises orally administering to the patient 20 mg of tasimelteon once daily before a target bedtime.

6. The method of claim 5 , wherein the patient is entrained to a 24 hour sleep-wake cycle in which the patient awakens at or near a target wake time following a daily sleep period of approximately 7 to 9 hours.

7. The method of claim 1 , wherein the treatment with the strong CYP1A2 inhibitor is discontinued prior to treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor.

8. The method of claim 2 , wherein the treatment with fluvoxamine is discontinued prior to treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor.

9. The method of claim 1 , wherein the CYP1A2 inhibitor is ciprofloxacin.

10. The method of claim 9 , wherein the treatment with ciprofloxacin is discontinued prior to treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor.

11. The method of claim 1 , wherein the CYP1A2 inhibitor is verapamil.

12. The method of claim 11 , wherein the treatment with verapamil is discontinued prior to treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor.

13. A method of treating a patient for a circadian rhythm disorder or for a sleep disorder wherein the patient is being treated with a strong CYP1A2 inhibitor selected from a group consisting of fluvoxamine, ciprofloxacin, and verapamil, the method comprising:
(A) discontinuing treatment with the strong CYP1A2 inhibitor and then
(B) treating the patient with 20 mg of tasimelteon once daily.

14. The method of claim 13 , that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder.

Assignees

• Vanda Pharmaceuticals Inc

Inventors

• Dressman Marlene Michelle
• Feeney John Joseph
• Licamele Louis William
• Polymeropoulos Mihael H

Classifications

• A61P43/00

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

• A61P5/00

  Drugs for disorders of the endocrine system · CPC title

• A61P5/38

  of the suprarenal hormones · CPC title

• A61P27/00

  Drugs for disorders of the senses · CPC title

• A61P25/26

  Psychostimulants, e.g. nicotine, cocaine · CPC title