Clinical evaluation of zaleplon in the treatment of insomnia

Ebbens, Marieke M.; Verster, Joris C.

doi:10.2147/nss.s6853

Cited by 7 publications

(1 citation statement)

References 69 publications

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“…Z-drugs are known to have less daytime sedation, tolerance or withdrawal potential, and anterograde amnesia compared to benzodiazepine [146][147][148]. However, Z-drugs also have adverse effects including drowsiness, nausea, dizziness, and unpleasant taste particularly for eszopiclone [148][149][150]. The use of zolpidem and eszopiclone for sleep onset and maintenance and zaleplon for sleep onset insomnia is recommended by AASM guidelines [134].…”

Section: Pharmacological Approachmentioning

confidence: 99%

Disturbance of Sleep and Circadian Rhythm in Hospitalized Patients

Park

Kyong

2023

Chronobiol Med

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Sleep and circadian disturbance are common in hospitalized patients. Problems related to sleep induction, frequent awakening, poor sleep quality, and disturbed circadian rhythm including daytime somnolence and nighttime arousal are frequently observed in the hospital. Disturbance of sleep and circadian rhythm could interfere recovery of the patients, prolong the length of stay, and contribute to patient dissatisfaction. Various factors affect sleep and circadian rhythm disturbance in the hospital. Intrinsic factors are related to patients, including medical and psychiatric conditions, uncontrolled pain, prescribed medications, and physical inactivity. External factors related to the hospital environment such as noisy environment, excessive exposure to artificial light, inappropriate humidity, and temperature are also known interrupters for sleep. Medical care provided by professionals, including nighttime vital sign monitoring, phlebotomy, and medication administration, can also contribute to sleep and circadian rhythm disturbances. This review aims to systematically address sleep and circadian rhythm disturbances in hospitalized patients, discuss factors that affect sleep in the hospital, and suggest non-pharmacological and pharmacological treatment options.

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Section: Pharmacological Approachmentioning

confidence: 99%

Disturbance of Sleep and Circadian Rhythm in Hospitalized Patients

Park

Kyong

2023

Chronobiol Med

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Insomnia in Elderly Patients: Recommendations for Pharmacological Management

2018

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Chronic insomnia affects 57% of the elderly in the United States, with impairment of quality of life, function, and health. Chronic insomnia burdens society with billions of dollars in direct and indirect costs of care. The main modalities in the treatment of insomnia in the elderly are psychological/behavioral therapies, pharmacological treatment, or a combination of both. Various specialty societies view psychological/behavioral therapies as the initial treatment intervention. Pharmacotherapy plays an adjunctive role when insomnia symptoms persist or when patients are unable to pursue cognitive behavioral therapies. Current drugs for insomnia fall into different classes: orexin agonists, histamine receptor antagonists, non-benzodiazepine gamma aminobutyric acid receptor agonists, and benzodiazepines. This review focuses on Food and Drug Administration (FDA)-approved drugs for insomnia, including suvorexant, low-dose doxepin, Z-drugs (eszopiclone, zolpidem, zaleplon), benzodiazepines (triazolam, temazepam), and ramelteon. We review the indications, dosing, efficacy, benefits, and harms of these drugs in the elderly, and discuss data on drugs that are commonly used off-label to treat insomnia, and those that are in clinical development. The choice of a hypnotic agent in the elderly is symptom-based. Ramelteon or short-acting Z-drugs can treat sleep-onset insomnia. Suvorexant or low-dose doxepin can improve sleep maintenance. Eszopiclone or zolpidem extended release can be utilized for both sleep onset and sleep maintenance. Low-dose zolpidem sublingual tablets or zaleplon can alleviate middle-of-the-night awakenings. Benzodiazepines should not be used routinely. Trazodone, a commonly used off-label drug for insomnia, improves sleep quality and sleep continuity but carries significant risks. Tiagabine, sometimes used off-label for insomnia, is not effective and should not be utilized. Non-FDA-approved hypnotic agents that are commonly used include melatonin, diphenhydramine, tryptophan, and valerian, despite limited data on benefits and harms. Melatonin slightly improves sleep onset and sleep duration, but product quality and efficacy may vary. Tryptophan decreases sleep onset in adults, but data in the elderly are not available. Valerian is relatively safe but has equivocal benefits on sleep quality. Phase II studies of dual orexin receptor antagonists (almorexant, lemborexant, and filorexant) have shown some improvement in sleep maintenance and sleep continuity. Piromelatine may improve sleep maintenance. Histamine receptor inverse agonists (APD-125, eplivanserin, and LY2624803) improve slow-wave sleep but, for various reasons, the drug companies withdrew their products.

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Rapid oral transmucosal delivery of zaleplon–lavender oil utilizing self-nanoemulsifying lyophilized tablets technology: development, optimization and pharmacokinetic evaluation

et al. 2022

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Based on the administration convenience, transmucosal buccal drug delivery allows special strength points over peroral routes for systemic delivery. It could achieve local or systemic effect and boost drugs’ bioavailability for agents with first pass metabolism. The current study aimed to manufacture and optimize a lavender oil–based nanoemulsion loaded with zaleplon and incorporate it into fast-disintegrating tablets to promote its dissolution and oral bioavailability via oral mucosa. Zaleplon-loaded nanoemulsions were devised with various levels of lavender oil (10% to 25%), the surfactant Sorbeth-20 (35% to 65%), and the co-surfactant HCO-60 (20% to 40%); the extreme vertices mixture statistical design was adopted. The droplet size and drug-loading efficiency were the evaluated. The optimal formulation was transformed into self-nanoemulsified lyophilized tablets (ZP-LV-SNELTs), which were tested for their uniformity of content, friability, and disintegration time with in-vitro release. Finally, the pharmacokinetic parameters of the ZP-LV-SNELTs were determined and compared with those of marketed formulations. The optimal nanoemulsion had a droplet size of 87 nm and drug-loading capacity of 185 mg/mL. ZP-LV-SNELTs exhibited acceptable friability and weight uniformity and a short disintegration time. The in-vitro release of ZP-LV-SNELTs was 17 times faster than that of the marketed tablet. Moreover, the optimal ZP-LV-SNELTs increased the bioavailability of zaleplon in rabbits by 1.6-fold compared with the commercial tablets. Hence, this investigation revealed that ZP-LV-SNELTs delivered zaleplon with enhanced solubility, a fast release, and boosted bioavailability thru oral mucosa which provided a favorable route for drug administration which is suggested to be clinically investigated in future studies

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Clinical evaluation of zaleplon in the treatment of insomnia

Cited by 7 publications

References 69 publications

Disturbance of Sleep and Circadian Rhythm in Hospitalized Patients

Disturbance of Sleep and Circadian Rhythm in Hospitalized Patients

Insomnia in Elderly Patients: Recommendations for Pharmacological Management

Rapid oral transmucosal delivery of zaleplon–lavender oil utilizing self-nanoemulsifying lyophilized tablets technology: development, optimization and pharmacokinetic evaluation

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