PMID- 17288686
OWN - NLM
STAT- MEDLINE
DCOM- 20070315
LR  - 20131121
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 23
IP  - 2
DP  - 2007 Feb
TI  - Effects of desloratadine and alcohol coadministration on psychomotor performance.
PG  - 313-21
AB  - OBJECTIVE: This study was set up to evaluate the effects of desloratadine 7.5 mg 
      daily, with and without alcohol, on sedation and psychomotor performance. 
      RESEARCH METHODS: In a double-blind, placebo-controlled, four-way crossover 
      trial, 25 adult patients were randomized to desloratadine 7.5 mg, desloratadine 
      7.5 mg plus alcohol, placebo, or placebo plus alcohol. Alcohol was weight 
      adjusted to an average blood alcohol concentration of 0.1%. Assessments included 
      the modified Romberg test, Stanford Sleepiness Scale, Digit Symbol Substitution 
      Test, Serial Add Subtract Reaction Time Test, and the Psychomotor Vigilance Test. 
      The primary variable was the mean score of each of the five tests averaged over 
      the treatment period, expressed as the mean percent change from baseline. 
      RESULTS: Across these assessments, differences between desloratadine alone or 
      with alcohol versus placebo alone or without alcohol, were not significant, 
      whereas most differences between desloratadine and placebo alone versus 
      desloratadine and placebo with alcohol were significant (p < 0.01). Thus, with or 
      without alcohol, desloratadine 7.5 mg does not increase sedation or impair 
      psychomotor performance. Most adverse events (AEs) were mild-to-moderate in 
      severity, with the most frequently reported individual AEs being headache, 
      fatigue, nausea, vomiting, and dry mouth. The study does have potential 
      limitations. The measures used are restricted to a particular profile of the 
      known effects of alcohol only, and the relatively high doses of alcohol used 
      alone demonstrate effects on psychomotor function and attention. CONCLUSIONS: A 
      single dose of desloratadine does not potentiate alcohol-mediated CNS impairment. 
      Desloratadine alone or in combination with alcohol was safe and well tolerated.
FAU - Scharf, Martin
AU  - Scharf M
AD  - Tri-State Sleep Disorders Center, Cincinnati, OH 45246, USA. 
      mscharf@tristatesleep.com
FAU - Berkowitz, David
AU  - Berkowitz D
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Histamine H1 Antagonists, Non-Sedating)
RN  - 3K9958V90M (Ethanol)
RN  - 7AJO3BO7QN (Loratadine)
RN  - FVF865388R (desloratadine)
SB  - IM
MH  - Adult
MH  - Arousal/drug effects
MH  - Ataxia/chemically induced
MH  - Double-Blind Method
MH  - Drug Interactions
MH  - Ethanol/administration & dosage/adverse effects/blood/*pharmacology
MH  - Fatigue/chemically induced
MH  - Female
MH  - Headache/chemically induced
MH  - Histamine H1 Antagonists, Non-Sedating/administration & dosage/adverse 
      effects/*pharmacology
MH  - Humans
MH  - Loratadine/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacology
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Psychomotor Performance/*drug effects
MH  - Reaction Time/drug effects
MH  - Vomiting/chemically induced
EDAT- 2007/02/10 09:00
MHDA- 2007/03/16 09:00
CRDT- 2007/02/10 09:00
PHST- 2007/02/10 09:00 [pubmed]
PHST- 2007/03/16 09:00 [medline]
PHST- 2007/02/10 09:00 [entrez]
AID - 10.1185/030079906X167363 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2007 Feb;23(2):313-21. doi: 10.1185/030079906X167363.