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“Introduction Antihistamines were first introduced in the 1940s and represent one of the most commonly used medications today.[1] The first-generation antihistamine doxylamine

succinate is a member of the ethanolamine class and was introduced into clinical use in the EU in the late 1950s. It acts by competitively inhibiting histamine at H1 receptors, the binding being readily reversible. It has hypnotic, anticholinergic, and local anesthetic effects, and shares the actions and uses of other antihistamines. The effects upon the central nervous system are fundamentally determined by the capacity to cross the blood–brain barrier and bind to the central H1 receptors.[2–4] Although sedation sometimes limits the clinical usefulness of doxylamine when GDC-0068 concentration ID-8 that effect is not desirable, it also provides an additional indication, shared by other antihistamines in the ethanolamine group: symptomatic treatment of insomnia.[1–3,5,6] Currently, doxylamine medicinal products have been authorized for more than 50 years, with an appropriate extent of use, for symptomatic treatment of occasional insomnia, making doxylamine a drug with a well established use. In fact, doxylamine alone or in combination with other drugs is available over the

counter in Australia, Belgium, Canada, France, Germany, Hungary, Ireland, Italy, Korea, New Zealand, Poland, Portugal, Slovenia, Spain, Switzerland, the UK, and the US. Dormidina® has been marketed in Spain since 1990 with a unique active ingredient: doxylamine hydrogen succinate 25 mg or 12.5 mg. Doxylamine hydrogen succinate 25 mg (salt) corresponds to doxylamine 17.4 mg (base). Doxylamine is indicated for the symptomatic treatment of occasional insomnia in adults aged 18 years and over, particularly those with difficulty in falling asleep, frequent interruptions during sleep, or early waking in the morning. Because its marketing authorization was approved before the implementation of the present regulatory standards, pharmacokinetic studies of doxylamine hydrogen succinate in its current pharmaceutical presentation (film-coated tablets) have never been performed under fed conditions.