Abstract
Insomnia and related sleep disorders (somnipathies) affect a large segment of the population, and result in a significant negative impact on quality of life and reduced or lost productivity. The speed of sleep onset is a critical characteristic of successful pharmacotherapeutic intervention for insomnia. Zolpidem, a non-benzodiazepine benzodiazepine receptor agonist (nBzRA) is widely used to treat insomnia. Although not itself a benzodiazepine (BZD), zolpidem has high binding affinity for the benzodiazepine receptor, which acts as a positive allosteric modulator of the GABAA receptor complex. It therefore increases the neuronal transmembrane influx of Cl- ions, thereby decreasing neuronal excitability and promoting sleep. In this four-way crossover, dose-ranging, multiple-treatment study, a lingual spray formulation of zolpidem was safe and well-tolerated and yielded more rapid pharmacokinetics (mean plasma concentration) and efficacy (visual analog scale and digit symbol substitution test) compared to oral tablets.
Highlights
Sleep is necessary for maintaining and promoting good health
The present study was designed in a manner to determine the pharmacokinetics, therapeutic efficacy, and safety/tolerability of two doses of zolpidem lingual spray (LS) compared to orally-administered drug in fasted (≥10-h) young healthy volunteers (N = 20 males, 23 females)
The present study was designed in a manner to determine the pharmacokinetics, efficacy, and safety/tolerability of two doses of zolpidem lingual spray (LS) compared to an orally-administered drug formulation in fasted (≥10-h) young healthy volunteers (N = 20 males, 23 females)
Summary
Inadequate or poor sleep has the opposite, negative, effect on quality of life, health, and performance. Disruptions of sleep quality or of sleep pattern occur in many forms and to variable degrees that result in sleep disorders (somnipathies). It leads to falls [2], motor vehicle accidents, increased healthcare utilization [3], worsening of comorbid and psychiatric disorders [4] [5] [6] [7], and even decreased survival rates [8]. Treatment can provide a medical, as well as quality of life, benefit [9] [10] [11]
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