A multicentre post-marketing surveillance study was conducted in Switzerland in routine practice and involved 1972 insomniac patients treated with zolpidem, an imidazopyridine hypnotic agent. The patients were representative of the general insomniac population (65% women; mean age 55 years; 29% over 65). Of the patients, 87% were treated with a zolpidem dosage of 10 mg/day and the median treatment duration was 30 days. All adverse events were collected through spontaneous reporting. A total of 175 patients (8.9%) reported 343 adverse events, and 102 (5.2%) of them discontinued treatment. CNS (central nervous system)-related adverse events accounted for 66% of the total, the most common events being residual daytime sedation and insufficient efficacy in 3.7% and 1.6%, respectively; confusion, disorientation, nervousness, nightmares, amnesia, impaired concentration and anxiety were observed in a lower proportion. Gastro-intestinal symptoms, headache and skin reactions were the most frequent non-CNS related effects. No serious adverse event was reported and no new risk factors or at-risk populations were identified. The safety profile of zolpidem is thus consistent with its known pharmacological properties, the results of previous clinical trials, and the cumulative international experience gained with this short-acting hypnotic drug.

Objective To assess the safety profile of slow-release (SR)The eÂect on supine blood pressure was minimal. In the subgroups of elderly and hypertensive patients alfuzosin in the treatment of benign prostatic obstruction (BPO), with special attention to orthostatic blood treated with SR alfuzosin, the cumulative incidence of asymptomatic orthostatic hypotension during the first pressure changes, postural symptoms and eÃcacy. Patients and methods Two placebo-controlled studies month of treatment was slightly higher than with placebo with no objective consequences on the inciinvolving 588 patients (292 receiving SR alfuzosin 5 mg twice daily and 296 a placebo) were pooled; dence of adverse events. The clinical eÃcacy of SR alfuzosin was confirmed by a significant improvement 51% of the patients were Á65 years of age and 43% had associated cardiovascular disease including hyperin urinary symptoms and a significant increase in maximum flow rates. tension and/or were receiving concomitant antihypertensive drugs.Conclusion SR alfuzosin (10 mg/day) can be administered safely without titration in patients with BPO, Results SR alfuzosin was very well tolerated with an overall incidence of adverse events similar to that of even in elderly and hypertensive patients. Its favourable benefit/risk ratio allows alfuzosin to be classified placebo (18.5% and 15.8% of patients, respectively) and an overall incidence of withdrawal from therapy as a clinically uroselective a 1 -blocker. Specific analysis of orthostatic changes in blood pressure is important for adverse events lower than that of placebo (3.4% and 5.7%, respectively). Adverse events potentially when assessing the safety profile of an a 1 -blocker in patients with BPO. related to vasodilatation were infrequent with SR alfuzosin (the same incidence as with placebo, i.e.Keywords Benign prostatic obstruction, slow-release alfuzosin, a 1 -blocker therapy, safety profile, clinical 2.7% of patients) and these adverse events occurred mainly during the first month of alfuzosin treatment.uroselectivity, orthostatic hypotension general practice [8]. In addition, besides improving LUTS Introduction and urodynamic variables, treatment with alfuzosin has a favourable impact on the quality of life of patients with The treatment of patients suÂering from benign prostatic obstruction (BPO) with a 1 -blocking agents is well estab-BPO [9]. Alfuzosin was initially available in Europe as an immediate-release formulation administered three lished and their eÂect on LUTS and urodynamics are assumed to be globally similar [1]. The main side-eÂects times daily. In fact, once-a-day and twice-a-day regimens have been shown to be associated with significantly associated with a 1 -blockers are postural symptoms relative to orthostatic hypotension, resulting from an impairbetter compliance (73% and 70%, respectively) than thrice-daily regimens (52%) [10]. In addition, the inciment of the compensatory reflex mechanism mediated by the sympathetic nervous system normally brought dence and severity of ...

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Tiapride is a substituted benzamide widely used in the management of agitation and aggressiveness in the elderly. The development of an oral solution is of particular interest in geriatric medicine and in patients with difficulties swallowing solid formulations. The bioequivalence between a sweetened, flavoured oral drop and tablet forms of tiapride was investigated in a crossover design in 18 healthy male volunteers after a 100mg single-dose administration of each formulation. Plasma concentration profiles were determined. No significant differences in the extent and rate of absorption (t(max), C(max), AUC(0-t) or AUC(0-infinity), C(max )/AUC(0-infinity)) were observed, where t(max) is the time to reach the maximum plasma concentration (C(max)), AUC(0-t) is the area under the concentration-time curve from zero to the last sample at which plasma concentration could be quantified, and AUC(0-infinity) is the area under the curve extrapolated to infinity. The plasma elimination half-lives were similar (4.37 hours and 4.61 hours) and the relative bioavailability of the drop formulation was 99.7%. These results demonstrated the bioequivalence of the two formulations. The drop formulation in this bioequivalence study was the one used for clinical evaluation in the target population of elderly patients experiencing restlessness and aggressive behaviour that was assessed in a prospective double-blind, randomised, previously published trial in 176 patients. In that study, tiapride as a drop formulation compared with melperone was safe and effective with regard to restlessness and aggressive behaviour in elderly patients.

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