On the therapeutic action of alpidem in anxiety disorders: an overview of the European data.

PMID 1974073


This review analyzes the available data on the therapeutic activity of alpidem in various anxiety syndromes. Up to now, 17 studies have been completed in Europe, dealing with a total population of more than 1500 patients suffering from either chronic (n = 987) or situational anxiety (n = 400). In a series of five placebo-controlled double-blind studies in situations of stress-induced anxiety (gastroscopy, minor surgery, cardiac catheterization), the therapeutic efficacy of alpidem was evident in 53% of the patients and significantly (P less than 0.001) superior to that of placebo (30%). In more than 400 patients suffering from generalized anxiety or adjustment disorders with anxious mood, six double-blind studies run against placebo or reference drug over a period of two to three weeks indicated an anxiolytic effect superior (P less than 0.01) to that of placebo and comparable to that of reference drugs (DZ, LZP, CZP). A long-term (6-12 months) open-label study conducted on a population of more than 300 patients suffering from chronic anxiety indicated that no tachyphylaxis occurs during prolonged treatment and that following abrupt drug discontinuation no withdrawal or rebound phenomena are observed. Globally, alpidem appears to be well tolerated with a minimum of dose-related, sedative effects (6-7% of the cases) and no effects on memory or cognitive functions. Four studies conducted specifically in an elderly population (n = 191) indicate that the elderly patients do not show an increased sensitivity to alpidem. On the contrary, as in adults, the anxiolytic effect was not accompanied by a reduction in performance or in cognitive functions nor by withdrawal reactions when treatment was discontinued.(ABSTRACT TRUNCATED AT 250 WORDS)

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Alpidem, ≥98% (HPLC), powder