Pharmacokinetics of zolpidem from sublingual zolpidem tartrate tablets in healthy elderly versus non-elderly subjects.

Background: Pharmacokinetic parameters of sedative-hypnotic medications can be influenced by age and gender.

Objective: This study analyzed pharmacokinetic parameters of zolpidem, formulated as a sublingual zolpidem tartrate tablet (ZST; Intermezzo®), in healthy elderly males and females (mean age 72 years) and in non-elderly males and females (34 years).

Methods: This was a randomized, single-dose, open-label, two-way crossover study evaluating pharmacokinetic parameters of 1.

Residual effects of low-dose sublingual zolpidem on highway driving performance the morning after middle-of-the-night use.

Study Objective: To evaluate next-morning driving performance after middle-of-the-night use of zolpidem 3.5 mg in a buffered sublingual formulation (ZST).

Design: Single-center, four-period, randomized, double-blind, placebo-controlled, crossover study.

Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle-of-the-night awakening in insomnia.

Objective: Evaluate potential gender effects on efficacy and safety of a buffered zolpidem sublingual tablet (ZST) formulation.

Methods: Post hoc analysis of the pivotal sleep laboratory and outpatient studies, per gender.

Results: In the sleep laboratory study, polysomnography-derived latency to persistent sleep after middle-of-the-night was significantly improved for both genders at both 1.

Gender differences in pharmacokinetics and pharmacodynamics of zolpidem following sublingual administration.

The effect of dose and gender on the pharmacokinetics (PK) and pharmacodynamics (PD) of zolpidem after administration of a buffered zolpidem sublingual tablet (ZST; Intermezzo®, Purdue Pharma L.P., Stamford, CT, USA) was evaluated in healthy non-elderly male and female volunteers.

Novel sublingual low-dose zolpidem tablet reduces latency to sleep onset following spontaneous middle-of-the-night awakening in insomnia in a randomized, double-blind, placebo-controlled, outpatient study.

Study Objectives: To evaluate efficacy and safety of 3.5-mg zolpidem tartrate sublingual tablets (ZST) on latency to sleep onset after middle-of-the-night (MOTN) awakenings in patients with insomnia characterized by difficulty returning to sleep after MOTN awakenings.

Design: Multicenter randomized, double-blind, placebo-controlled, parallel-group.

Pharmacologic management of insomnia in children and adolescents: consensus statement.

Objective: The purpose of this work was to develop a consensus statement on the current status and future role for pharmacologic management of insomnia in children and adolescents.

Method: The National Sleep Foundation, in collaboration with Best Practice Project Management, Inc, convened expert representatives involved in the study and treatment of pediatric insomnia and conducted a 2-day conference to examine the role of pharmacologic management of pediatric insomnia and to make recommendations regarding the development of clinical trials in this area. After a series of presentations providing background on the current knowledge of pediatric insomnia and its treatment alternatives, workgroups provided recommendations for the evaluation of pharmacologic treatment of insomnia in specific populations of children and adolescents and developed guidelines for the core methodologic issues relevant to the design of clinical trials.