IP Library Granted Patent US 11,771,667
Granted Patent B1
US 11,771,667 · App. 18/176,816 · 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 11,771,667
App. No.
18/176,816
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 (42)

1. A method of treating excessive daytime sleepiness, attention deficit hyperactivity disorder, binge eating disorder, depression, or cognitive impairment in a lactating human mother feeding an infant with her breast milk, comprising:

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

feeding the infant the breast milk obtained from the mother at least about 5 hours after administration of the solriamfetol to the mother;

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

wherein the potential for adverse events in the infant due to the solriamfetol is decreased.

2. The method of claim 1 , wherein the adverse event is agitation, insomnia, anorexia, or reduced weight gain.

3. The method of claim 1 , wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk.

4. The method of claim 1 , where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work disorder, major depression, or Parkinson's disease.

5. The method of claim 1 , wherein the lactating mother is from 1 day to 24 months postpartum.

6. The method of claim 1 , wherein the lactating mother is from 10 days to 12 months postpartum.

7. The method of claim 1 , wherein the lactating mother is between the ages of 18 and 45 years.

8. A method of treating excessive daytime sleepiness, attention deficit hyperactivity disorder, binge eating disorder, depression, or cognitive impairment in a lactating human mother feeding an infant with her breast milk, comprising:

orally administering solriamfetol to the mother at a once-daily dose of about 75 mg; and

feeding the infant the breast milk obtained from the mother at least about 5 hours after administration of the solriamfetol to the mother;

wherein the daily infant dose of solriamfetol is reduced to about 0.15 mg or lower; and

wherein the potential for adverse events in the infant due to the solriamfetol is decreased.

9. The method of claim 8 , wherein the adverse event is agitation, insomnia, anorexia, or reduced weight gain.

10. The method of claim 8 , wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk.

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

12. The method of claim 8 , wherein the lactating mother is from 1 day to 24 months postpartum.

13. The method of claim 8 , wherein the lactating mother is from 10 days to 12 months postpartum.

14. The method of claim 8 , wherein the lactating mother is between the ages of 18 and 45 years.

15. A method of treating excessive daytime sleepiness, attention deficit hyperactivity disorder, binge eating disorder, depression, or cognitive impairment in a lactating human mother feeding an infant with her breast milk, comprising:

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

feeding the infant the breast milk obtained from the mother at least about 5 hours after administration of the solriamfetol to the mother;

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

wherein the exposure of the infant to the solriamfetol from the breast milk is decreased.

16. The method of claim 15 , wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk.

17. The method of claim 15 , where the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work disorder, major depression, or Parkinson's disease.

18. The method of claim 15 , wherein the lactating mother is from 1 day to 24 months postpartum.

19. The method of claim 15 , wherein the lactating mother is from 10 days to 12 months postpartum.

20. The method of claim 15 , wherein the lactating mother is between the ages of 18 and 45 years.

21. A method of treating excessive daytime sleepiness, attention deficit hyperactivity disorder, binge eating disorder, depression, or cognitive impairment in a lactating human mother feeding an infant with her breast milk, comprising:

orally administering solriamfetol to the mother at a once-daily dose of about 75 mg; and

feeding the infant the breast milk obtained from the mother at least about 5 hours after administration of the solriamfetol to the mother;

wherein the daily infant dose of solriamfetol is reduced to about 0.15 mg or lower; and

wherein the exposure of the infant to the solriamfetol from the breast milk is decreased.

22. The method of claim 21 , wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk.

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

24. The method of claim 21 , wherein the lactating mother is from 1 day to 24 months postpartum.

25. The method of claim 21 , wherein the lactating mother is from 10 days to 12 months postpartum.

26. The method of claim 21 , wherein the lactating mother is between the ages of 18 and 45 years.

Assignments (2)
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 →