Mirtazapine effects on alertness and sleep in patients as recorded by interactive telecommunication during treatment with different dosing regimens

This double-blind study compared mirtazapine's effects on alertness and sle ep between parallel groups treated for 2 weeks according to a fixed regimen of 30 mg at bedtime (N = 69) and one that increased in dose from 15 to 30 mg at bedtime after the first week (N = 71). These patients with depression used an interactive telephone/computer system for daily alertness and slee p recordings on self-rating scales before and during treatment. Efficacy (1 7-item Hamilton Rating Scale for Depression [HAM-D], Clinical Global Impres sion Scale [CGI]) and safety assessments were made by participating psychia trists. Both groups' alertness ratings were subnormal at baseline and even lower after the first dose. The ratings recovered after the second dose and increased progressively to levels 18% higher than those at baseline by the end of treatment. Patients receiving the fixed dose reported earlier sleep onset and longer duration. Similar mean changes in HAM-D scores (approxima tely -40%) and frequencies of CGI responders (>50%) occurred in both groups . The regimens were equally well tolerated. Somnolence, the most frequent s ide effect, was reported by only 10% of each group during the first week an d by fewer patients during the second. Mirtazapine in fixed and ascending n octurnal dosing regimens was found to facilitate sleep, but it does not gen erally reduce daytime alertness. The fixed regimen seems preferable because of its greater effects on sleep.