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“1 Introduction Doxylamine succinate, an ethanolamine-based antihistamine, shares the actions and uses of other antihistamines. Because of its sedative effect, doxylamine medicinal products (alone or in combination with other drugs) have been authorized for more
than 50 years with an appropriate extent of use for short-term management of insomnia [1–5]. Currently, it is a medical product with a legal base of well-established use in Europe. Based on clinical practice, the recommended adult dose for doxylamine hydrogen succinate as a nighttime sleep aid is 25 mg, once daily, taken orally up to half an hour before bedtime. If drowsiness is excessive, the dosage should be reduced to 12.5 mg. Doses higher than 25 mg are not recommended. Dormidina® has been marketed in Spain since 1990 with a unique active ingredient: doxylamine hydrogen succinate, 12.5 mg or 25 mg. Because its marketing authorization was Belnacasan in vitro approved before the implementation of the oxyclozanide present regulatory
standards, a new pharmacokinetic study of doxylamine hydrogen succinate in its current pharmaceutical presentation (film-coated tablets) has been recently published . This study provides updated data on the pharmacokinetic parameters of doxylamine following a 25 mg dose in both fasting and fed conditions. The results indicate that the kinetic parameters of doxylamine were not affected by a high-fat, high-calorie food intake, and the drug was safe and well tolerated by the subjects. Furthermore, no differences between genders were observed . No data on the dose proportionality of doxylamine were available. Therefore, the main objective of this study was to evaluate and compare the bioavailability with regard to dose proportionality between the two marketed strengths (12.