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Last Updated: December 12, 2025

Claims for Patent: 10,179,119

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Summary for Patent: 10,179,119

Title:	Method of treatment
Abstract:	Embodiments of the invention relate to the treatment of sleep disturbances in individuals with Smith-Magenis Syndrome (SMS).
Inventor(s):	Christian Lavedan, Mihael H. Polymeropoulos
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US15/326,934
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,179,119
Patent Claims:	1. A method for the treatment of sleep disturbances in a patient with Smith-Magenis Syndrome that comprises internally administering to the patient an effective amount of tasimelteon once daily before bedtime. 2. The method of claim 1, wherein the treatment of sleep disturbance is manifested as an improvement in nighttime sleep. 3. The method of claim 2, wherein the improvement in nighttime sleep is manifested as a reduction in the percentage of wake period within the patient's sleep interval. 4. The method of claim 1, wherein the treatment of sleep disturbances is manifested as improvement in one or more of the following: total amount of nighttime sleep; number, timing, and length of nighttime awakenings; sleep onset; wake time; number, timing, and length of daytime naps; improvement in clinical global impression of change (CGI-C); improvement in clinical global impression of severity (CGI-S); and improvement in behavior. 5. The method of claim 1, wherein the dose of tasimelteon is between about 5 mg/day and about 100 mg/day. 6. The method of claim 5, wherein the dose of tasimelteon is about 20 mg/d. 7. The method of claim 1, wherein the tasimelteon is administered between one-half hour and two hours before bed time. 8. The method of claim 7, wherein the tasimelteon is administered between one-half hour and one and one-half hours before bed time. 9. The method of claim 8, wherein the tasimelteon is administered one hour before bed time. 10. The method of claim 1, wherein the treatment effects are maintained by ongoing daily administration of tasimelteon.

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