> Details

Horoszok, Lucy; Baleeiro, Thais; D'Aniello, Fabiana; Gropper, Savion; Santos, Benjamin; Guglietta, Antonio; Roth, Thomas

A single‐dose, randomized, double‐blind, double dummy, placebo and positive‐controlled, five‐way cross‐over study to assess the pharmacodynamic effects of lorediplon in a phase advance model of insomnia in healthy Caucasian adult male subjects

Reference
management

Bookmarks

Remove from
bookmarks

Share this on Whatsapp

Close

Bookmarks



You can manage bookmarks using lists, please log in to your user account for this.
  • Media type: E-Article
  • Title: A single‐dose, randomized, double‐blind, double dummy, placebo and positive‐controlled, five‐way cross‐over study to assess the pharmacodynamic effects of lorediplon in a phase advance model of insomnia in healthy Caucasian adult male subjects
  • Contributor: Horoszok, Lucy; Baleeiro, Thais; D'Aniello, Fabiana; Gropper, Savion; Santos, Benjamin; Guglietta, Antonio; Roth, Thomas
  • Published: Wiley, 2014
  • Published in: Human Psychopharmacology: Clinical and Experimental, 29 (2014) 3, Seite 266-273
  • Language: English
  • DOI: 10.1002/hup.2395
  • ISSN: 0885-6222; 1099-1077
  • Origination:
  • Footnote:
  • Description: ObjectiveA 5‐h phase advance model of insomnia was used to evaluate the efficacy of lorediplon, a new non‐benzodiazepine hypnotic.MethodsThirty‐five male, healthy subjects were included in a five‐way randomized cross‐over study. During each of the periods, sleep was recorded, and residual effects were measured. All subjects received lorediplon 1, 5, and 10 mg, placebo, and zolpidem 10 mg (i.e., active control).ResultsPolysomnographic evaluation revealed that lorediplon (5 and 10 mg) significantly decreased wake after sleep onset (WASO) and increased total sleep time. Analysis by quarters of the night showed a progressive increasing effectiveness of lorediplon 10 mg across the first three quarters. Lorediplon increased non‐rapid eye movement slow wave sleep and stage N2 sleep in the second and third quarters. The magnitude of these effects was dose related, with minimal effects seen with 1 mg. No residual effects were observed 13 h post dose.ConclusionsLorediplon demonstrated a dose‐dependent improvement in sleep, whereas zolpidem showed a more sustained WASO effect. No next‐day hangover effects were observed. These sleep effects are also consistent with the pharmacokinetic profile of lorediplon. These results warrant clinical trials in patients with insomnia. Copyright © 2014 John Wiley & Sons, Ltd.