Acute alertness-promoting effects of a novel histamine subtype-3 receptor inverse agonist in healthy sleep-deprived male volunteers

Clin Pharmacol Ther. 2010 Dec;88(6):831-9. doi: 10.1038/clpt.2010.205. Epub 2010 Oct 27.

Abstract

The alertness-promoting effect of MK-0249 (10 or 50 mg), a histamine subtype-3 receptor (HRH3) inverse agonist (IA), was evaluated in the stimulant reference sleep deprivation model (SRSDM) using a double-blind, double-dummy, placebo- and modafinil- (200 mg) controlled, four-period crossover design in 24 healthy young men. The two primary hypotheses were related to sleep latency (first appearance of one epoch of stage 2, 3, or 4 or REM sleep, as detected using polysomnography (PSG)) at 8:00 AM on day 2. Statistically significant increases in sleep latency were observed in association with the use of modafinil 200 mg (9.07 min; P < 0.0001), MK-0249 50 mg (5.17 min; P = 0.008), and MK-0249 10 mg (5.45 min; P = 0.005) at the maintenance of wakefulness test (MWT) at 8:00 AM. Sleep latency was higher when averaged over all MWT time points (P < 0.0001 for modafinil and for both doses of MK-0249). The alertness-promoting effect with the use of MK-0249 in the SRSDM suggests that HRH3 IAs may be effective in disorders involving excessive somnolence.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Inverse Agonism*
  • Histamine Agonists / pharmacology*
  • Histamine Agonists / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Receptors, Histamine H3 / physiology*
  • Sleep Deprivation / drug therapy*
  • Sleep Deprivation / physiopathology
  • Sleep Stages / drug effects
  • Sleep Stages / physiology
  • Time Factors
  • Wakefulness / drug effects*
  • Wakefulness / physiology
  • Young Adult

Substances

  • Histamine Agonists
  • Receptors, Histamine H3