Zopiclone 7.5mg/5ml oral suspension

Currently, approximately 40% of patients with dementia develop some form of sleep disorder. Benzodiazepines are widely prescribed but pose the risk of tolerance and cognitive decline; however, Z-drugs may offer safer alternatives. Therefore, this systematic review aimed to analyze the effect of benzodiazepines and Z-drugs on sleep disorders in patients with dementia. Two authors conducted a systematic search in PubMed, Scopus, Web of Science, Espistemonikos, and ACCESSSS for studies published between 2019 and 2024 using the MeSH terms "dementia", "sleep disorders", and "pharmacotherapy". Randomized clinical trials comparing benzodiazepines, Z-drugs, or innovative medications with placebo or other drugs were included. Sleep and cognitive outcomes were assessed using validated instruments; the ROB-2 tool evaluated the risk of bias. The protocol was registered in "PROSPERO". Three randomized clinical trials involving a total of 192 patients were included in the review. Zopiclone increased the main duration of nighttime sleep by 81 min, Zolpidem reduced nighttime awakenings by 21 min, and Eszopiclone improved sleep quality, benefited the progression of sleep architecture, and reduced mental symptoms such as fear and anxiety. Z-drugs show superior efficacy and safety over benzodiazepines, improving sleep and cognitive symptoms in dementia. Personalized treatment and further research across dementia subtypes are needed to optimize long-term outcomes.

Abstract licence: CC BY

AimSedative hypnotics can impair driving performance to a degree comparable to blood alcohol concentrations of 0.05%-0.08%. This study aimed to evaluate the residual effect of vornorexant, a novel orexin receptor antagonist, on next morning driving performance relative to a predefined clinically meaningful threshold.MethodsParticipants received 10 and 20 mg of vornorexant and placebo for eight consecutive nights and zopiclone on Days 1 and 8 in a four-way crossover and double-blind manner. Driving performance at 9-h post-dose was assessed measuring the standard deviation of the lateral position (SDLP) on Days 2 and 9 (days after single and repeated administration) using a validated driving simulator. Pharmacokinetics were also evaluated.ResultsSixty-one participants were randomized and 55 completed the study. The mean of drug-placebo changes in SDLP (ΔSDLP) following vornorexant 10 and 20 mg were 0.767 and 2.132 cm on Day 2, and -0.422 and -0.040 cm on Day 9, respectively, whereas approximately 6 cm in zopiclone. All the upper bounds of the 90% confidence intervals of these changes were below the predefined clinically significant threshold. Symmetry analysis found no differences in the proportion of participants with ΔSDLP exceeding the threshold in either impairing or improving from 0 cm, at vornorexant 10 mg on Days 2 and 9 and 20 mg on Day 9. Pharmacokinetic analysis showed consistent plasma concentrations of vornorexant in single and repeated dosing.ConclusionsSingle and repeated administration of 10 and 20 mg vornorexant induced no clinically meaningful impairment in driving performance in healthy Japanese participants.

Abstract licence: CC BY