IP Library Granted Patent US 11,771,666
Granted Patent B1
US 11,771,666 · App. 18/148,682 · Granted Oct 3, 2023

Methods of administering solriamfetol to lactating women

Inventor: Herriot Tabuteau (New York, NY)
Assignee: Axsome Malta Ltd.
A61K31/165
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Quick Facts
Patent No.
US 11,771,666
App. No.
18/148,682
Granted
Oct 3, 2023
Kind
B1
Abstract

Provided herein according to some embodiments is a method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a subject treated with solriamfetol comprising: orally administering the solriamfetol to the subject at a daily dose of about 37.5 mg to about 300 mg; and feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, thereby decreasing potential for adverse events from solriamfetol in an infant.

Claims (30)

1. A method of reducing exposure to solriamfetol in an infant fed breast milk obtained from a human subject treated with solriamfetol comprising:

orally administering the solriamfetol to the subject at a once-daily dose of about 150 mg; and

feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject,

wherein the daily infant dose of solriamfetol is reduced to about 0.3 mg or lower.

2. The method of claim 1 , wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol exposure.

3. The method of claim 1 , wherein the subject is from 1 day to 24 months postpartum.

4. The method of claim 3 , wherein the subject is from 10 days to 12 months postpartum.

5. The method of claim 1 , wherein the subject is being treated with solriamfetol for narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, attention deficit/hyperactivity disorder, depression, cognitive impairment, or binge eating disorder.

6. A method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk obtained from a human subject treated with solriamfetol comprising:

administering solriamfetol orally at a once-daily dose of about 150 to the subject; and

feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject,

wherein the daily infant dose of solriamfetol is reduced to about 0.3 mg or lower.

7. The method of claim 6 , wherein the adverse events are one or more of agitation, insomnia, anorexia, or reduced weight gain.

8. The method of claim 6 , wherein the subject is being treated with solriamfetol for narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, attention deficit/hyperactivity disorder, depression, cognitive impairment, or binge eating disorder.

9. The method of claim 6 , wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol exposure.

10. The method of claim 6 , wherein the subject is from 1 day to 24 months postpartum.

11. The method of claim 10 , wherein the subject is from 10 days to 12 months postpartum.

12. A method for treating a disorder treatable with solriamfetol in a human subject producing breast milk for feeding an infant, comprising:

administering solriamfetol orally at a once-daily dose of about 150 to the subject; and

reducing exposure of the infant to solriamfetol and/or decreasing the potential for adverse events in the infant fed breast milk from the subject, comprising feeding the infant breast milk obtained from the subject at least about 5 hours after administering the solriamfetol to the subject,

wherein the daily infant dose of solriamfetol is reduced to about 0.3 mg or lower.

13. The method of claim 12 , wherein the disorder treatable with solriamfetol is narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, cognitive impairment, attention deficit/hyperactivity disorder, depression, or binge eating disorder.

14. The method of claim 12 , wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol exposure.

15. The method of claim 12 , wherein the adverse events are one or more of agitation, insomnia, anorexia, or reduced weight gain.

16. The method of claim 12 , wherein the subject is from 1 day to 24 months postpartum.

17. The method of claim 16 , wherein the subject is from 10 days to 12 months postpartum.

18. The method of claim 12 , wherein the subject is a woman between the ages of 18 and 45 years.

19. The method of claim 5 , where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, major depression, shift work disorder, or Parkinson's disease.

20. The method of claim 8 , where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, major depression, shift work disorder, or Parkinson's disease.

21. The method of claim 13 , where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, major depression, shift work disorder, or Parkinson's disease.

Assignments (3)
SECURITY INTEREST Recorded May 9, 2025
From: AXSOME THERAPEUTICS, INC.; AXSOME MALTA LTD.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 071247/0836 →
SECURITY INTEREST Recorded Sep 9, 2024
From: AXSOME MALTA LTD
To: HERCULES CAPITAL, INC.
Reel/Frame 068900/0023 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 28, 2023
From: TABUTEAU, HERRIOT
To: AXSOME MALTA LTD.
Reel/Frame 064420/0738 →