IP Library Granted Patent US 11,872,204
Granted Patent B1
US 11,872,204 · App. 18/323,236 · Granted Jan 16, 2024

Methods of administering solriamfetol to lactating women

Inventor: Herriot Tabuteau (New York, NY)
Assignee: Axsome Malta Ltd.
A61K31/27A61K9/0053
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Quick Facts
Patent No.
US 11,872,204
App. No.
18/323,236
Granted
Jan 16, 2024
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 (22)

1. A method of preventing a reduction in number of feedings and/or a reduction in volume of milk ingested 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 150 mg; and

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 about 0.3 mg or lower.

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

3. The method of claim 1 , wherein the subject is from 10 days to 12 months postpartum.

4. The method of claim 1 , wherein the subject is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, depression, binge eating disorder, Parkinson's disease, or cognitive impairment.

5. The method of claim 4 , wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, major depression, or Parkinson's disease.

6. The method of claim 4 , wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, Parkinson's disease, or attention deficit hyperactivity disorder.

7. The method of claim 1 , wherein the subject is being treated with solriamfetol to improve wakefulness.

8. The method of claim 1 , wherein the subject is a woman between the ages of 18 and 50 years.

9. A method of preventing a reduction in number of feedings and/or a reduction in volume of milk ingested 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 75 mg; and

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 about 0.15 mg or lower.

10. The method of claim 9 , wherein the subject is from 1 day to 24 months postpartum.

11. The method of claim 9 , wherein the subject is from 10 44 days to 12 months postpartum.

12. The method of claim 9 , wherein the subject is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, depression, binge eating disorder, Parkinson's disease, or cognitive impairment.

13. The method of claim 12 , wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, major depression, or Parkinson's disease.

14. The method of claim 12 , wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, Parkinson's disease, or attention deficit hyperactivity disorder.

15. The method of claim 9 , wherein the subject is being treated with solriamfetol to improve wakefulness.

16. The method of claim 9 , wherein the subject is a woman between the ages of 18 and 50 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 →
Continuity (1)
Continuation 18148682 · Dec 30, 2022
Cited By (1)
US 12,263,145