Method for correcting plasma melatonin levels and pharmaceutical formulation comprising melatonin

摘要

In order to correct a melatonin deficiency or distortion in the plasma melatonin level and profile in a human subject, there is administered to a human in which such a deficiency or distortion had been diagnosed, over a predetermined time period including at least part of the nocturnal period, an amount of melatonin in controlled-release form, such that the melatonin is released according to a profile which, taking into account the existing profile, simulates the profile in plasma of a human having a normal endogenous melatonin plasma profile. The invention also relates to a pharmaceutical controlled-release formulation, which comprises melatonin in combination with at least one pharmaceutical carrier, diluent or coating, the formulation being adapted to release melatonin over a predetermined time period, according to a profile which, taking into account the existing profile, simulates the profile in plasma of a human having a normal endogenous melatonin profile. The method of the invention may be e.g. applied to the prevention of sudden infant death syndrome in infants, and then comprises a preliminary screening step in order to determine the plasma melatonin levels, in order to select infants having a deficient plasma melatonin level.