Allergy medication in Japanese volunteers: Treatment effect of single doses on nocturnal sleep architecture and next day residual effects

HPRU Medical Research Centre, University of Surrey, Guildford, UK.
Current Medical Research and Opinion (Impact Factor: 2.65). 07/2006; 22(7):1343-51. DOI: 10.1185/030079906X112660
Source: PubMed


To evaluate the acute effects of two histamine H(1)-receptor antagonists on nocturnal sleep architecture and on next day cognitive function and psychomotor performance.
This was a single-site, randomized, double-blind, 3-way crossover study, comparing the effects of a single dose of chlorpheniramine (6 mg), fexofenadine (120 mg) and placebo in 18 healthy (male and female) Japanese volunteers aged 20-55 years. Volunteers were resident for 3 days and each period was separated by a minimum 5-day washout period. The three treatments were administered at 23.00 h. Overnight sleep was measured from 23.00 h to 07.00 h using polysomnography. Residual effects were studied at 07.00 h and 9.00 h the next morning, with the latency to sleep (sleep latency test) measured at 09.30 h.
Compared with placebo, chlorpheniramine increased the latencies to sleep onset and rapid eye movement (REM) sleep (p < or = 0.05 for both), and reduced the duration of REM sleep (p <or= 0.01), but this was not observed with fexofenadine. As far as residual effects the next morning were concerned there were decrements in performance with chlorpheniramine, but not with fexofenadine. Chlorpheniramine 6 mg impaired divided attention (p < 0.001), vigilance (p < 0.05), working memory (p < 0.0001) and sensori-motor performance (p < 0.01), and the latency to daytime sleep was reduced (p < 0.0001). Six adverse events possibly related to study medication were reported during the study, three of which were related to placebo, two to fexofenadine and one to chlorpheniramine.
These findings suggest that a single nocturnal dose of fexofenadine has advantages over the first-generation antihistamine chlorpheniramine, being free of disruption of night-time sleep and detrimental effects on cognitive performance the next day. It is likely that this advantage will remain with chronic ingestion, but this would need to be confirmed.

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    • "Allergic rhinitis, for instance, is associated with sleep loss or an impaired sleep pattern [19] through nasal obstruction and the enlargement of tonsils and adenoids. On the other hand, allergy medication may impair sleep architecture for instance by increasing the latencies to sleep onset and reducing the REM sleep duration [20]. However, due to the cross-sectional nature of this study, we do not know the cause-effect direction of the association and it is not possible to rule out that lack of sufficient sleep is a risk factor for allergy onset instead of the more intuitive relationship between allergy nasal obstructive symptoms and sleep disturbances. "
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    • "This psychoactive drug blocks histamine H1 receptors in the brain and often results in sleepiness and psychomotor disturbances (Tashiro et al., 2008). Not surprisingly, approximately 2–6 mg of chlorpheniramine has been shown to delay psychomotor responses and impair driving performance (Boyle et al., 2006; Tashiro et al., 2008; Van Ruitenbeek et al., 2008; Verster and Volkerts, 2004). Such side effects could be the cause or a factor in accidents and road traffic injury (Cimbura et al., 1982; Sen et al., 2007; Skegg et al., 1979; Woratanarat et al., 2009). "
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