CA2964504C — Oral dosage form comprising a cyclopropanecarboxamide derivative for use in treating insomnia

USPTO Abstract

In the present invention relates to the dosage form for use in the treatment of insomnia comprising a therapeutically effective amount of compound A and at least one pharmaceutically acceptable excipient, wherein said therapeutically effective amount is a single daily dose ranging from 2.5 mg to 10 mg, wherein said single daily dose achieves a mean Cmax of from about 3.0 ng/ml to about 7.2 ng/ml, a mean AUC(0-24) of from about 15.9 ng*hr/ml, or a mean AUC(0-inf) of from about 19.8 ng*hr/ml to about 53.1 ng*hr/ml to about 23.8 ng*hr/ml for each 1 mg of compound A after administration to human subjects, and said compound A is (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide represented by the following formula. (see above formula)