JP-2022514275-A5 -

Dates

Publication Date

20221226

Application Date

20191217

Description

Those skilled in the art will recognize, or can verify through simple routine experimentation, many equivalents to the specific embodiments described herein. Such equivalents are intended to be covered by the claims. This application also includes the following aspects. [Aspect 1] A method for treating non-24-hour sleep-wake disorder, comprising administering to a patient in need of such treatment approximately 0.05 mg to approximately 30 mg of gaboxadol or a pharmaceutically acceptable salt thereof. [Aspect 2] The method according to claim 1, which results in improvement of one or more symptoms of non-24-hour sleep-wake disorder in a patient. [Appearance 3] The method according to claim 2, wherein the improvement is brought about over a period of at least 6 hours after administration. [Aspect 4] The method according to claim 1, wherein the patient is administered a composition comprising about 1 mg to about 15 mg of gaboxadol or a pharmaceutically acceptable salt thereof. [Aspect 5] The method according to claim 1, wherein the in vivo plasma profile of a patient six hours after administration of gaboxadol or a pharmaceutically acceptable salt thereof is reduced by more than 50%. [Pattern 6] The method according to claim 1, wherein the patient's AUC 6-12 six hours after administration of gaboxadol or a pharmaceutically acceptable salt thereof is less than 75% of the administered dose. [Appearance 7] The method according to claim 1, which results in improvement of at least one symptom selected from the group consisting of irregular sleep patterns, irregular circadian rhythms, insomnia, apraxia, e.g., ideational apraxia, ideomotor apraxia, motor apraxia, limb apraxia, speech apraxia, cognitive impairment, difficulty concentrating, confusion, depressed mood, diarrhea, nausea, fatigue, alopecia, headache, balance disorders, photosensitivity, arthralgia, loss of muscle coordination (ataxia), menstrual irregularities, myalgia, suicidal ideation, weight gain, and hallucinations. [Patent 8] The method according to claim 3, wherein the composition brings about improvement in the patient over a period of more than six hours. [Aspect 9] The method according to claim 3, wherein the composition brings about improvement in the patient for at least 12 hours. [Aspect 10] The method according to claim 1, further comprising administering melatonin or tasimerteon to the patient. [Personalization 11] A method for treating non-24-hour sleep-wake disorder, comprising administering gaboxadol or a pharmaceutically acceptable salt thereof to a patient in need thereof, thereby resulting in an in vivo plasma profile containing a Cmax of less than approximately 400 ng/ml. [Aspect 12] A method for treating non-24-hour sleep-wake disorder, comprising administering gaboxadol or a pharmaceutically acceptable salt thereof to a patient in need thereof, resulting in an in vivo plasma profile containing an AUC of less than approximately 900 ng·h/ml for 6-12 .