Metaxalone products, method of manufacture, and method of use

A method of preventing sedation in a patient in need of metaxalone comprising

• determining a dosing regimen for metaxalone to be administered to a patient in need thereof,
• determining that a substance that is a known inhibitor of a cytochrome P450 isozyme (CYP) selected from CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 is currently administered or will be administered to the patient, and
• altering dosing of metaxalone administered to the patient from the determined dosing regimen while the known inhibitor of the CYP is coadministered to the patient to prevent sedation.

A method of optimizing the dose of metaxalone to administer to a patient in need of a skeletal muscle relaxant, comprising

• determining that a substance that is a known inducer or a known inhibitor of a cytochrome P450 isozyme (CYP) selected from CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 is administered to a patient in need of a skeletal muscle relaxant;
• and
• optimizing a dose of metaxalone administered to the patient by administering a dose of metaxalone greater than a standard dose if a known inducer of the CYP is administered to the patient or administering a dose less than the standard dose of metaxalone if a known inhibitor of the CYP is administered to the patient.

The method of 19, wherein the standard dose of metaxalone is 800 mg.

-37. (canceled)

A method of avoiding an adverse event when administering metaxalone, comprising

• determining that a patient in need of metaxalone therapy is taking a substance that is a known inhibitor or a known inducer of cytochrome P450 isozyme (CYP) selected from CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4, and
• adjusting administration to the patient of metaxalone or the substance to avoid an adverse event associated with a change in the metabolism of metaxalone.

-64. (canceled)