The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study.

Objective: This study examined the effects of milnacipran on polysomnographic (PSG) measures of sleep and subjective complaints in patients with fibromyalgia and disturbed sleep.

Methods: This was a single-site, double-blind, placebo-controlled, two-period crossover PSG study. Eligible subjects (aged 28-72 y) were randomized (1:1) to milnacipran (100 mg/d) or placebo for crossover period 1, and vice versa for period 2.

Efficacy and safety of doxepin 6 mg in a model of transient insomnia.

Introduction: The efficacy and safety of doxepin (DXP) 6mg tablets were evaluated in healthy adults in a model of transient insomnia.

Methods: This was a randomized, double-blind, parallel-group, placebo-controlled study in healthy adults using a model of transient insomnia. A first-night effect combined with a 3-h phase advance was implemented to induce transient insomnia in healthy adults.

Biomechanical comparison of a new staple technique with tension band wiring for transverse patella fractures.

Background: The tension band wiring technique is the most common method of transverse patella fracture fixation. Since post-operative instabilities have been reported for this technique, alternative osteosynthesis solutions are of interest. We investigated the biomechanical behaviour of a new staple technique for treatment of transverse patella fractures in a cadaveric model.

Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in elderly patients with primary insomnia: a randomized, double-blind, placebo-controlled crossover study.

Objectives: Evaluate efficacy and safety of the histamine-H1 antagonist doxepin at doses of 1 mg, 3 mg, and 6 mg in elderly adults with primary insomnia.

Design: A randomized, double-blind, placebo-controlled, crossover design was used in this population of elderly adults with primary insomnia (DSM-IV). Each treatment period consisted of 2 polysomnographic (PSG) assessment nights with a 5- or 12-day drug-free interval between periods.

Low-dose sublingual zolpidem tartrate is associated with dose-related improvement in sleep onset and duration in insomnia characterized by middle-of-the-night (MOTN) awakenings.

Study Objectives: To evaluate the efficacy and safety of low-dose, sublingual zolpidem tartrate when taken during a scheduled middle-of-the-night (MOTN) awakening in subjects with insomnia characterized by difficulty returning to sleep following MOTN awakenings.

Design: Randomized, double-blind, placebo-controlled, 3-way crossover study.

Methods: Each treatment period consisted of 2 consecutive nights of dosing separated by a washout of 5 to 12 days.

Efficacy and safety of as-needed, post bedtime dosing with indiplon in insomnia patients with chronic difficulty maintaining sleep.

Objective: To evaluate the efficacy and tolerability of immediate release indiplon capsules in patients with chronic insomnia using an "as-needed" dosing strategy in response to difficulty falling back to sleep following a middle of the night, nocturnal awakening.

Methods: Adult outpatients (N=264; 71% female; age, 46 years) who met DSM-IV criteria for primary insomnia, with average total sleep time (TST) < 6.5 hours and >8 nights in the past month with nocturnal awakenings, were randomized to 4 weeks of double-blind treatment with 10 mg or 20 mg indiplon capsules, or placebo.

Efficacy and tolerability of indiplon in transient insomnia.

Objective: The efficacy of indiplon was evaluated by polysomnography (PSG) in an experimental model of transient insomnia consisting of the first night effect combined with a 2-hour phase advance.

Methods: Healthy volunteers age 21-64 years (N=593; 62% female; mean +/- SEM) years, 32 +/- 0.39) were randomized to double-blind treatment with a single nighttime dose of indiplon (10 mg or 20 mg) or placebo.

Long-term nightly treatment with indiplon in adults with primary insomnia: results of a double-blind, placebo-controlled, 3-month study.

Objectives: To evaluate the efficacy and safety of indiplon in primary insomnia.

Design: Randomized, double-blind, placebo-controlled, 3-month study.

Setting: Multi-center outpatient setting.

A pilot study evaluating acute use of eszopiclone in patients with mild to moderate obstructive sleep apnea syndrome.

Objective: To evaluate the effects of eszopiclone on measures of respiration and sleep using polysomnography in patients with mild to moderate obstructive sleep apnea syndrome (OSAS).

Methods: This double-blind, randomized crossover study included patients (35-64 years) with mild-to-moderate OSAS [apnea and hypopnea index (AHI) range 10 and 40]. Patients received either eszopiclone 3mg or placebo for two consecutive nights, with a 5-7 day washout between treatments.

Effects of synthetic conjugated estrogens A on sleep quality in postmenopausal women with nocturnal diaphoresis and/or hot flushes: a pilot study.

In a single-center, double-blind, placebo-controlled pilot study, patients who received 0.625 mg daily of synthetic conjugated estrogens A experienced a statistically significant reduction in the average number of hot flushes and galvanic skin responses. The polysomnographic change in sleep measures did not reach statistical significance, but the data suggest an overall improvement in sleep quality in the treatment group.

Effects of desloratadine and alcohol coadministration on psychomotor performance.

Objective: This study was set up to evaluate the effects of desloratadine 7.5 mg daily, with and without alcohol, on sedation and psychomotor performance.

Research Methods: In a double-blind, placebo-controlled, four-way crossover trial, 25 adult patients were randomized to desloratadine 7.

A polysomnography study of eszopiclone in elderly patients with insomnia.

Objective: To evaluate the safety and efficacy of eszopiclone 2 mg in elderly patients (aged 64-86 years) with chronic insomnia.

Methods: This was a randomized, double-blind, placebo-controlled 2-week study. Patients meeting DSM-IV criteria for primary insomnia and screening polysomnography criteria (wakefulness after sleep onset [WASO] >or= 20 min and latency to persistent sleep >or= 20 min) were randomized to 2 weeks of nightly treatment with eszopiclone 2 mg (n = 136) or placebo (n = 128).

Sodium oxybate for narcolepsy.

Sodium oxybate (Xyrem), also known as gamma-hydroxybutyric acid, is the only therapeutic specifically approved in the USA for the treatment of cataplexy in narcolepsy. The US FDA has recently expanded its indication to include excessive daytime sleepiness associated with narcolepsy. In contrast to the antidepressants and stimulants commonly used to treat the disorder, sodium oxybate is the only compound that addresses both sets of symptoms and, when used properly, is less likely to lead to the development of tolerance and other undesirable side effects.

A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia.

Study Objectives: Evaluate the efficacy of eszopiclone in primary insomnia.

Design/setting: Randomized, double-blind, placebo-controlled multicenter in outpatient setting with weekly visits.

Participants: Two-hundred thirty one men and women aged 65 to 85 years (mean age 72.

Eszopiclone for the treatment of insomnia.

Eszopiclone, a single-isomer, non-benzodiazepine hypnotic agent, is approved for use in the US for the treatment of insomnia for patients who have difficulty falling asleep (sleep latency) as well as for those who have difficulty staying asleep (sleep maintenance). Efficacy in sleep maintenance has not been consistently demonstrated with previous hypnotics, and long-term efficacy and safety data are lacking for these agents. In clinical trials, eszopiclone 3 mg significantly improved objective and subjective sleep measures in transient and chronic insomnia in adults.

Effects of temazepam 7.5 mg and temazepam 15 mg on sleep maintenance and sleep architecture in a model of transient insomnia.

Objective: To compare the effects of temazepam 7.5 mg and temazepam 15 mg on sleep maintenance during the last third of the night (last 160 min) and on sleep architecture throughout the night.

Research Design And Methods: This was a retrospective analysis of a previously reported double-blind, randomized, uncontrolled, parallel-group, multicenter study.

The efficacy and safety of the melatonin agonist beta-methyl-6-chloromelatonin in primary insomnia: a randomized, placebo-controlled, crossover clinical trial.

Background: While melatonin agonists are known to regulate circadian sleep rhythms, it is not clear whether melatonin agonists have a direct soporific effect. It has been suggested that melatonin's soporific effect is secondary to its ability to induce hypothermia. beta-Methyl-6-chloromelatonin is a high-affinity melatonin receptor agonist that is not associated with hypothermia.

Effect of zolpidem on sleep in women with perimenopausal and postmenopausal insomnia: a 4-week, randomized, multicenter, double-blind, placebo-controlled study.

Background: Although most adults in the United States obtain less sleep than they need, women report more sleep deprivation throughout their lifetime than do men. The prevalence of self-reported sleep difficulty increases as women make the transition from the premenopausal to the postmenopausal period.

Objective: The purpose of this study was to assess the clinical efficacy and safety of zolpidem as a treatment for insomnia in perimenopausal and postmenopausal women.

Comparison of temazepam 7.5 mg with temazepam 15 mg for the treatment of transient insomnia.

Objective: To demonstrate the equivalent efficacy of temazepam 7.5 mg and temazepam 15 mg for the treatment of transient insomnia.

Research Design And Methods: This was a double-blind, parallel group, multicenter study.

Self-reported sleep in postmenopausal women.

Objective: We aimed to find how self-reported sleep (measured by the St. Mary's Hospital Sleep Questionnaire) in postmenopausal women having hot flash activity was related to objective sleep (actigraphy), psychological and somatic symptoms [Women's Health Questionnaire (WHQ)], and cognitive test performance (computerized tests). A secondary aim was to find if self-reported sleep showed expected correlations with hyperarousal (Hyperarousal Scale).

The pharmacokinetics of sodium oxybate oral solution following acute and chronic administration to narcoleptic patients.

This trial was conducted to evaluate the pharmacokinetics and safety of a sodium oxybate (gamma-hydroxybutyrate [GHB]) oral solution in narcoleptic patients after acute and chronic treatment. An open-label, two-period, two-treatment study design was used. Trial subjects included 13 patients with polysomnographically confirmed narcolepsy.

The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia.

Objective: Fibromyalgia (FM) is associated with the sleep phenomenon of alpha intrusion, and with low growth hormone secretion. Sodium oxybate has been shown to increase both slow-wave sleep and growth hormone levels. This double blind, randomized, placebo controlled crossover trial was conducted to evaluate the effects of sodium oxybate on the subjective symptoms of pain, fatigue, and sleep quality and the objective polysomnographic (PSG) sleep variables of alpha intrusion, slow-wave (stage 3/4) sleep, and sleep efficiency in patients with FM.

Comparative efficacy of zolpidem and temazepam in transient insomnia.

This study compared hypnotic effects of zolpidem 10 mg, temazepam 15 mg and placebo in healthy adults. Two factors expected to promote insomnia, the 'first night effect' and a 2-hour phase advance, were combined in a single night laboratory-based double-blinded protocol. This was a multi-center study, with data collected in 13 sleep laboratories.