Claims for Patent: 11,771,666

Summary for Patent: 11,771,666

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:	US18/148,682
Patent Claims:	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.