Effects of loratadine/montelukast on vigilance and alertness task performance in a simulated cabin environment.
BACKGROUND
Sedating effects of some medications used to treat allergic rhinitis (AR) symptoms can impair an individual's ability to function optimally. The objective of this study was to characterize the effects of a single dose of loratadine/montelukast (L/M) versus placebo and diphenhydramine on daytime somnolence and psychomotor performance in healthy volunteers.


METHODS
In this single-center, randomized, double-blind, placebo- and active-controlled,three-way crossover study, healthy volunteers received single doses of placebo, L/M 10 mg/10 mg, and diphenhydramine 50 mg. Subjects (n=23) were evaluated under simulated cabin pressure using the following tools: Vigilance and Tracking Task (VigTrack), measuring vigilance and tracking performance; the Multi-Attribute Task Battery (MAT), measuring ability to perform multiple tasks simultaneously; and the Stanford Sleepiness Scale (SSS), measuring sedative effects of medication, at baseline and each hour from 1 to 6 hours postdose. Safety was monitored via adverse events and vital signs.


RESULTS
Performances on VigTrack and MAT from 1 to 6 hours after dosing were not significantly different between L/M and placebo groups; in contrast, diphenhydramine resulted in significant impairment of tracking for up to 5 hours (P< or =0.01) and vigilance performance for up to 3 hours (P< or =0.05) on VigTrack versus placebo. Scores of subjective sleepiness as measured by SSS were similar for patients treated with L/M versus placebo, whereas significant increases in sleepiness occurred between 1-5 hours posttreatment in diphenhydramine-treated patients versus placebo-treated patients (P< or =0.05).


CONCLUSIONS
L/M is similar to placebo in effects on daytime somnolence and psychomotor performance. L/M treatment resulted in significantly less sleepiness and impairment of vigilance and tracking than diphenhydramine.
Valk
P J L
PJ
TNO Netherlands Organization for Applied Scientific Research, ZG Soesterberg, The Netherlands. pierre.valk@tno.nl
Simons
M
M
D000085:Acetates / Q000008:administration & dosage / Q000009:adverse effects*; D000328:Adult; D000531:Altitude; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001274:Atmospheric Pressure; D018592:Cross-Over Studies; D003521:Cyclopropanes; D004155:Diphenhydramine / Q000009:adverse effects*; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D017336:Loratadine / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D011597:Psychomotor Performance / Q000187:drug effects*; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects*; D013440:Sulfides; D055815:Young Adult
D000085:Acetates; D018926:Anti-Allergic Agents; D003521:Cyclopropanes; D004338:Drug Combinations; D011804:Quinolines; D013440:Sulfides; D017336:Loratadine; D004155:Diphenhydramine; C093875:montelukast