To compare the antihypertensive efficacy and the tolerability of two dosage regimens of isradipine sustained release (SRO) in the elderly, 48 essential hypertensives, aged 70 +/- 5 years, with diastolic blood pressure (DBP) 96 to 105 mmHg were randomized to receive, according to a double-blind, parallel group study, isradipine SRO 2.5 or 5 mg once daily for six weeks. Seven patients discontinued the study, due to inefficacy (n = 3) or side effects (n = 4). After six weeks of therapy, isradipine SRO significantly reduced systolic blood pressure (SBP) and DBP, irrespective of the dose administered. Mean SBP/DBP in the 5-mg isradipine SRO group decreased by 22/15 mmHg at peak time (four to six hours after dosing) and 21/13 mmHg at the end of the dose interval (24 +/- 1 hours after dosing); in the 2.5-mg group the reductions were 21/13 mmHg and 17/10 mmHg, respectively. At the end of the dose interval, the normalization rate (DBP at less-than-or-equal-to 90 mmHg) was 60% with 5 mg and 52% with 2.5 mg of isradipine SRO. Side effects were reported by five patients on 5 mg and four on 2.5 mg, with edema and headache as the more frequent complaints. No orthostatic phenomena were reported. In mild hypertension in the elderly, isradipine SRO once daily is an effective, long-lasting blood pressure lowering agent, even when given at the 2.5-mg dose, that is, at a dosage lower than that proved effective in most mild to moderate younger hypertensives. Isradipine SRO 5 mg once daily is safe and well tolerated for the first-step therapy of mild hypertension in the elderly, with a high normalization rate.