Objectives To investigate the administration time-dependent anti hypertensive efficacy of valsartan in non-dipper patients. Background Previous results have indicated that valsartan administration at bedtime, as opposed to upon wakening, may improve the diurnal : nocturnal ratio of blood pressure without loss in 24-h coverage and efficacy. Methods We studied 148 non-dipper patients with grade 1 -2 essential hypertension, aged 53.0 +/- 12.6 years, who were randomly assigned to receive valsartan (1160 mg/day) as a monotherapy either on awakening or at bedtime. Blood pressure was measured every 20 min during the day and every 30 min at night for 48 consecutive hours before and after 3 months of treatment. Physical activity was simultaneously monitored every minute by wrist actigraphy to accurately calculate the diurnal and nocturnal means of blood pressure on a per subject basis. Results The significant blood pressure reduction after 3 months of valsartan (P < 0.001) was similar for both treatment times (13.1 and 8.5 mmHg reduction in the 24-h mean of systolic and diastolic blood pressure with morning administration; 14.7 and 10.3 mmHg with bedtime administration; P > 0.126 for treatment-time effect). The diurnal : nocturnal ratio of blood pressure was significantly increased only when valsartan was administered before bedtime, which resulted in 75% of the patients in this group reverting to dippers, a significant increase in the percentage of patients with controlled blood pressure over 24 h, and a reduction in urinary albumin excretion. Conclusions In non-dipper hypertensive patients, dosing time with valsartan should be chosen at bedtime, for improved efficacy during the nocturnal resting hours, as well as the potential associated reduction in cardiovascular risk. J Hypertens 23:1913-1922 (c) 2005 Lippincott Williams & Wilkins.