PMID- 26464455
OWN - NLM
STAT- MEDLINE
DCOM- 20160826
LR  - 20151028
IS  - 1461-7285 (Electronic)
IS  - 0269-8811 (Linking)
VI  - 29
IP  - 11
DP  - 2015 Nov
TI  - Psychomotor effects, pharmacokinetics and safety of the orexin receptor 
      antagonist suvorexant administered in combination with alcohol in healthy 
      subjects.
PG  - 1159-69
LID - 10.1177/0269881115609015 [doi]
AB  - A double-blind crossover study investigated psychomotor effects, 
      pharmacokinetics, and safety of the orexin receptor antagonist suvorexant with 
      and without alcohol. Healthy adults (n=31) were randomized to receive placebo or 
      suvorexant (40 mg) plus placebo solution or alcohol (0.7 g/kg) in each of four 
      treatments (single doses; morning administration). The US Food and Drug 
      Administration approved suvorexant dose is 10 mg (up to 20 mg) daily. 
      Pharmacodynamic effects were assessed using tests of digit vigilance (DVT; 
      primary endpoint), choice reaction time, digit symbol substitution, numeric 
      working memory, immediate/delayed word recall, body sway and subjective 
      alertness. Suvorexant alone did not significantly affect DVT reaction time, but 
      did impact some pharmacodynamic tests. Suvorexant with alcohol increased reaction 
      time versus either alone (mean difference at 2 h: 44 ms versus suvorexant, 
      p<0.001; 24 ms, versus alcohol, p<0.05) and had additive negative effects on 
      tests of vigilance, working/episodic memory, postural stability and alertness. No 
      effects of suvorexant alone or with alcohol were observed by 9 h. No important 
      changes in pharmacokinetic parameters were observed upon co-administration. All 
      treatments were generally well tolerated without serious adverse events. In 
      conclusion, co-administration of 40 mg suvorexant and 0.7 g/kg alcohol had 
      additive negative psychomotor effects. Patients are advised not to consume 
      alcohol with suvorexant.
CI  - (c) The Author(s) 2015.
FAU - Sun, Hong
AU  - Sun H
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Yee, Ka Lai
AU  - Yee KL
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Gill, Sean
AU  - Gill S
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Liu, Wen
AU  - Liu W
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Li, Xiaodong
AU  - Li X
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Panebianco, Deborah
AU  - Panebianco D
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Mangin, Eric
AU  - Mangin E
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Morrison, Dennis
AU  - Morrison D
AD  - QPS-Biokinetic, Springfield, MI, USA.
FAU - McCrea, Jacqueline
AU  - McCrea J
AD  - Merck & Co., Inc., Kenilworth, NJ, USA jackie_mccrea@merck.com.
FAU - Wagner, John A
AU  - Wagner JA
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Troyer, Matthew D
AU  - Troyer MD
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151013
PL  - United States
TA  - J Psychopharmacol
JT  - Journal of psychopharmacology (Oxford, England)
JID - 8907828
RN  - 0 (Azepines)
RN  - 0 (Orexin Receptor Antagonists)
RN  - 0 (Triazoles)
RN  - 081L192FO9 (suvorexant)
RN  - 3K9958V90M (Ethanol)
SB  - IM
EIN - J Psychopharmacol. 2016 Jan;30(1):95. PMID: 26645210
MH  - Adult
MH  - *Azepines/adverse effects/pharmacokinetics/pharmacology
MH  - Double-Blind Method
MH  - Drug Synergism
MH  - *Ethanol/adverse effects/pharmacokinetics/pharmacology
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Orexin Receptor Antagonists/adverse effects/pharmacokinetics/pharmacology
MH  - Psychomotor Performance/*drug effects
MH  - Reaction Time/drug effects
MH  - *Triazoles/adverse effects/pharmacokinetics/pharmacology
MH  - Young Adult
OTO - NOTNLM
OT  - Alcohol
OT  - pharmacokinetics
OT  - pharmacology
OT  - psychomotor performance
OT  - suvorexant
EDAT- 2015/10/16 06:00
MHDA- 2016/08/27 06:00
CRDT- 2015/10/15 06:00
PHST- 2015/10/15 06:00 [entrez]
PHST- 2015/10/16 06:00 [pubmed]
PHST- 2016/08/27 06:00 [medline]
AID - 0269881115609015 [pii]
AID - 10.1177/0269881115609015 [doi]
PST - ppublish
SO  - J Psychopharmacol. 2015 Nov;29(11):1159-69. doi: 10.1177/0269881115609015. Epub 
      2015 Oct 13.