Side effects of low-dose mirtazapine and amitriptyline in patients with insomnia: a randomized, double-blind, placebocontrolled trial

Abstract

This study reveals the frequency, nature, and severity of the self-reported side effects of a low-dose amitriptyline and mirtazapine in comparison to placebo. It is assumed that in the future these results in addition to the results of effectiveness will facilitate the selection process for the most appropriate hypnotic for patients. More specifically, the results of this study may help, support, and facilitate the decision-making in general practice for use of mirtazapine and amitriptyline as off-label treatment of insomnia. Our study indicates that the patients in the mirtazapine arm in week 6 reported statistically more significant attributed SEs than those in the placebo arm. Increased occurrence of attributed SEs in the amitriptyline arm was not significant compared to the placebo arm. As estimated with the GEE model these differences decreased after 12 weeks of treatment.