Claims for Patent: 11,793,776

Summary for Patent: 11,793,776

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:	US18/176,855
Patent Claims:	1. A method for treating a postpartum human subject, who is producing breast milk, for a disorder amenable to treatment with solriamfetol, comprising: orally administering solriamfetol to the subject at a once-daily dose of about 150 mg; and feeding an 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; and wherein the potential for adverse events in the infant due to the solriamfetol is decreased, wherein the subject is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, Parkinson's disease, binge eating disorder, or cognitive impairment. 2. 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. 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 10 days to 12 months postpartum. 5. The method of claim 1, wherein the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 6. The method of claim 1, wherein the cognitive impairment is due to narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 7. A method for treating a postpartum human subject, who is producing breast milk, for a disorder amenable to treatment with solriamfetol, comprising: orally administering solriamfetol to the subject at a once-daily dose of about 75 mg; and feeding an 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; and wherein the potential for adverse events in the infant due to the solriamfetol is decreased, wherein the subject is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, Parkinson's disease, binge eating disorder, or cognitive impairment. 8. The method of claim 7, wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk. 9. The method of claim 7, wherein the subject is from 1 day to 24 months postpartum. 10. The method of claim 7, wherein the subject is from 10 days to 12 months postpartum. 11. The method of claim 7, wherein the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 12. The method of claim 7, wherein the cognitive impairment is due to narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 13. A method for treating a postpartum human subject, who is producing breast milk, for a disorder amenable to treatment with solriamfetol, comprising: orally administering solriamfetol to the subject at a once-daily dose of about 150 mg; and feeding an 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; and wherein the exposure of the infant to the solriamfetol from the breast milk is decreased, wherein the subject is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, Parkinson's disease, binge eating disorder, or cognitive impairment. 14. The method of claim 13, wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk. 15. The method of claim 13, wherein the subject is from 1 day to 24 months postpartum. 16. The method of claim 13, wherein the subject is from 10 days to 12 months postpartum. 17. The method of claim 13, wherein the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 18. The method of claim 13, wherein the cognitive impairment is due to narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 19. A method for treating a postpartum human subject, who is producing breast milk, for a disorder amenable to treatment with solriamfetol, comprising: orally administering solriamfetol to the subject at a once-daily dose of about 75 mg; and feeding an 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; and wherein the exposure of the infant to the solriamfetol from the breast milk is decreased, wherein the subject is being treated with solriamfetol for excessive daytime sleepiness, narcolepsy, obstructive sleep apnea, shift work disorder, attention deficit hyperactivity disorder, Parkinson's disease, binge eating disorder, or cognitive impairment. 20. The method of claim 19, wherein the infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol from the breast milk. 21. The method of claim 19, wherein the subject is from 1 day to 24 months postpartum. 22. The method of claim 19, wherein the subject is from 10 days to 12 months postpartum. 23. The method of claim 19, wherein the excessive daytime sleepiness is due to narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease. 24. The method of claim 19, wherein the cognitive impairment is due to narcolepsy, obstructive sleep apnea, shift work, or Parkinson's disease.