Composition: Each film-coated tablet contains 5 mg of lemborexant.
Product Description: (See Table 1.)
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Non-proprietary name: Lemborexant.
Chemical name: (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide.
Molecular formula: C22H20F2N4O2.
Molecular weight: 410.42.
Description: Lemborexant occurs as a white powder and is freely soluble in methanol or benzyl alcohol, soluble in ethanol (99.5), and practically insoluble in water.
Melting point: 177°C.
Partition coefficient: 3.7.
Excipients/Inactive Ingredients: Yellow ferric oxide, titanium oxide, magnesium stearate, talc, low substituted hydroxypropylcellulose, lactose hydrate, hydroxypropylcellulose, hypromellose, and macrogol 6000 are also present as inactive ingredients.