Claims for Patent: 11,779,554

Summary for Patent: 11,779,554

Title:	Methods of administering solriamfetol to lactating women
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.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Malta Ltd
Application Number:	US18/176,860
Patent Claims:	1. A method of reducing the risk of agitation in an infant that is 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 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. 2. The method of claim 1, wherein the infant does not experience agitation 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 1, wherein the subject is from 11 days to 12 months postpartum. 5. 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, binge eating disorder, depression, Parkinson's disease, or cognitive impairment. 6. The method of claim 5, wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, depression, or Parkinson's disease. 7. The method of claim 5, wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, Parkinson's disease, or attention deficit hyperactivity disorder. 8. The method of claim 1, wherein the subject is being treated with solriamfetol to improve wakefulness. 9. The method of claim 1, wherein the subject is a woman between the ages of 18 and 50 years. 10. A method of reducing the risk of agitation in an infant that is 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 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 reduced to about 0.15 mg or lower. 11. The method of claim 10, wherein the infant does not experience agitation due to solriamfetol exposure. 12. The method of claim 10, wherein the subject is from 1 day to 24 months postpartum. 13. The method of claim 10, wherein the subject is from 11 days to 12 months postpartum. 14. The method of claim 10, wherein the subject is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, binge eating disorder, depression, Parkinson's disease, or cognitive impairment. 15. The method of claim 14, wherein the excessive daytime sleepiness is associated with narcolepsy, obstructive sleep apnea, shift work, depression, or Parkinson's disease. 16. The method of claim 14, wherein the cognitive impairment is associated with narcolepsy, obstructive sleep apnea, shift work, Parkinson's disease, or attention deficit hyperactivity disorder. 17. The method of claim 10, wherein the subject is being treated with solriamfetol to improve wakefulness. 18. The method of claim 10, wherein the subject is a woman between the ages of 18 and 50 years.