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
| Autor: | Benjamin Santos, Savion Gropper, Thomas Roth, Thais Baleeiro, Lucy Horoszok, Fabiana D'Aniello, Guglietta Antonio |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Zolpidem Time Factors Pyridines medicine.drug_class Polysomnography Placebo White People Lorediplon Hypnotic Young Adult Double-Blind Method Sleep Initiation and Maintenance Disorders Surveys and Questionnaires Insomnia medicine Humans Hypnotics and Sedatives Pharmacology (medical) Slow-wave sleep Cross-Over Studies Dose-Response Relationship Drug Crossover study Psychiatry and Mental health Pyrimidines Treatment Outcome Neurology Anesthesia Pyrazoles Sleep Stages Neurology (clinical) medicine.symptom Sleep onset Sleep Psychology medicine.drug |
| Zdroj: | Human Psychopharmacology: Clinical and Experimental. 29:266-273 |
| ISSN: | 0885-6222 |
| Popis: | Objective A 5-h phase advance model of insomnia was used to evaluate the efficacy of lorediplon, a new non-benzodiazepine hypnotic. Methods Thirty-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). Results Polysomnographic 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. Conclusions Lorediplon 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. |
| Databáze: | OpenAIRE |
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