QUVIVIQ

11 DESCRIPTION QUVIVIQ contains daridorexant, an orexin receptor antagonist, present as daridorexant hydrochloride salt.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ The chemical name of daridorexant hydrochloride is (S)-(2-(5-chloro-4-methyl-1 H -benzo[ d ]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2 H -1,2,3-triazol-2-yl)phenyl)methanone hydrochloride. The molecular formula is C 23 H 23 N 6 O 2 Cl * HCl. The molecular weight is 487.38 g/mol. The structural formula is: Daridorexant hydrochloride is a white to light yellowish powder that is very slightly soluble in water. QUVIVIQ tablets are intended for oral administration. Each film-coated tablet contains daridorexant 25 mg or 50 mg, equivalent to 27 mg or 54 mg of daridorexant hydrochloride, respectively. The inactive ingredients are croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, and silicon dioxide. In addition, the film coating contains the following inactive ingredients: glycerin, hypromellose, iron oxide black, iron oxide red, microcrystalline cellulose, talc, titanium dioxide, and, in the 50 mg tablet only, iron oxide yellow. Chemical Structure