The invention belongs to the field of pharmaceutical preparations, and relates to
ramelteon sublingual tablets and a preparation method thereof. The
sublingual tablet contains effective amounts of
ramelteon, a filler, a disintegrant, a
lubricant, and a flavoring agent, and the proportion of a main
drug is 0.1 to 0.5%; the filler is selected from one or a combination of
mannitol,
lactose,
sucrose and
xylitol; the disintegrant is selected from one or the combination of crospovidone, cross linked
sodium carboxymethyl cellulose, and low-substituted
hydroxypropyl cellulose; and the
lubricant is selected from one or a combination of
magnesium stearate, aerosil, and
sodium stearyl fumarate; and the flavoring agent is
mint flavor. The invention also provides the preparation method of the ramelteonsublingual tablets, that is,
ramelteon and the filler are ground and mixed by a
ball mill, and mixed with the disintegrating agent, the
lubricant, and the flavoring agent, and the materials are pressed to prepare tablets. The ramelteon
sublingual tablet of the invention can avoid the
first pass effect of the liver and improve the
bioavailability.