Night‐time sedating H ₁ ‐antihistamine increases daytime somnolence but not treatment efficacy in chronic spontaneous urticaria: a randomized controlled trial

Abstract

BackgroundMany physicians believe that the most effective way to treat chronic urticaria is to take a nonsedating second-generation H1-antihistamine in the morning and a sedating first-generation H1-antihistamine, usually hydroxyzine, at night to enhance sleep. But is this belief well founded?ObjectivesTo test this belief by comparing the effectiveness and prevalence of unwanted sedative effects when treating patients with chronic spontaneous urticaria (CSU) with levocetirizine 15 mg daily plus hydroxyzine 50 mg at night (levocetirizine plus hydroxyzine) vs. levocetirizine 20 mg daily (levocetirizine monotherapy).MethodsIn this randomized, double-blind, cross-over study, 24 patients with difficult-to-treat CSU took levocetirizine plus hydroxyzine or levocetirizine monotherapy for periods of 5 days each. At the end of each treatment period, assessments were made of quality of life (Chronic Urticaria Quality of Life Questionnaire, CU-Q2oL), severity of urticaria symptoms (Urticaria Activity Score, UAS), sleep disturbance during the night and daytime somnolence.ResultsBoth treatments significantly decreased UAS, night-time sleep disturbances and CU-Q2oL scores (P < 0·001) without significant differences between the two. Compared with baseline, daytime somnolence was significantly reduced by levocetirizine monotherapy (P = 0·006) but not by levocetirizine plus hydroxyzine (P = 0·218). Direct comparison of the two treatment modalities in terms of daytime somnolence favoured levocetirizine monotherapy (P = 0·026).ConclusionsThe widespread belief that sleep is aided by the addition of a sedating first-generation H1-antihistamine, usually hydroxyzine, at night is not supported. These results are in line with the urticaria guidelines, which state that first-line treatment for urticaria should be new-generation, nonsedating H1-antihistamines only.

BSACI guideline for the management of chronic urticaria and angioedema

“…Sedation and impaired psychomotor function is reduced with second-generation antihistamines, it but can still occur. Although a sedating antihistamine at night can sometimes be useful, the long half-life of hydroxyzine can cause daytime somnolence [76]. Additional anti-inflammatory effects as suggested by the various antihistamine manufacturers may be relevant to the treatment of chronic urticaria, but the impact on clinical practice has not been quantified [77].…”

Aquagenic urticaria: diagnostic and management challenges

“…While there have been trials demonstrating the greater efficacy of second-generation H 1 antihistamines compared to first-generation H 1 antihistamines in patients with chronic spontaneous urticaria, there have been no comparable studies to date looking at patients with AU. At best, anecdotal reports show that many patients with AU fail to achieve symptomatic control with oral antihistamines alone 1,3–5,20…”

Urticaria: a Multidisciplinary Disease. Where Are We Now?

“…In a recent double-blind crossover study in the British Journal of Dermatology, patients on second-generation non-sedating antihistamines were randomized to first-generation H1-antihistamines at night versus placebo. There was no sleep benefit or added symptom control in those on first-generation H1-antihistamines, and daytime somnolence increased [21].…”