Identifying clinically important difference on the Epworth Sleepiness Scale: results from a narcolepsy clinical trial of JZP-110.

Background: While scores ≤10 on the Epworth Sleepiness Scale (ESS) are within the normal range, the reduction in elevated ESS score that is clinically meaningful in patients with narcolepsy has not been established.

Methods: This post hoc analysis of a clinical trial of patients with narcolepsy evaluated correlations between Patient Global Impression of Change (PGI-C) and ESS. Data of adult patients with narcolepsy from a double-blind, 12-week placebo-controlled study of JZP-110, a wake-promoting agent, were used in this analysis.

Evaluation of the effect of JZP-110 in patients with narcolepsy assessed using the Maintenance of Wakefulness Test censored to 20 minutes.

Objective: To evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20 min of a 40-min MWT.

Methods: In a 4-week, placebo-controlled crossover design (Study 201; N = 33) and a 12-week parallel-group design (Study 202; N = 93), JZP-110 was evaluated in narcolepsy patients using changes from baseline in the 40-min MWT as the primary endpoint. Effect sizes based on the change from baseline in mean MWT sleep latency were calculated using 20-min censored MWT data and compared to 40-min MWT data.

Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy.

Background: JZP-110 is a wake-promoting agent with dopaminergic and noradrenergic activity.

Methods: This double-blind, crossover study, randomized adults with narcolepsy with or without cataplexy (N = 33) to placebo or JZP-110 at 150 mg/day (weeks 1 and 3) increased to 300 mg/day (weeks 2 and 4). Patients had to have baseline Epworth Sleepiness Scale (ESS) scores ≥10 and mean sleep latencies ≤10 min on the Maintenance of Wakefulness Test (MWT).

Armodafinil for the treatment of excessive sleepiness associated with mild or moderate closed traumatic brain injury: a 12-week, randomized, double-blind study followed by a 12-month open-label extension.

Objective: To evaluate the efficacy and tolerability of armodafinil in patients with excessive sleepiness following mild or moderate closed traumatic brain injury (TBI).

Design: Randomized, placebo-controlled, double-blind trial followed by open-label extension.

Setting: 40 US centers.

A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.

Study Objectives: To evaluate the effects of single doses of gabapentin 250 and 500 mg on polysomnographic (PSG) and participant-reported sleep measures in a 5-h phase advance insomnia model.

Methods: Adults reporting occasional disturbed sleep received gabapentin 500 mg (n = 125), 250 mg (n = 125), or placebo (n = 127) 30 min prior to bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, post-sleep questionnaire, and the Karolinska Sleep Diary (KSD).

Eszopiclone for insomnia associated with attention-deficit/hyperactivity disorder.

Objective: To evaluate efficacy and safety of eszopiclone compared with placebo in children and adolescents with insomnia associated with attention-deficit/hyperactivity disorder (ADHD).

Methods: A 12-week, randomized, double-blind, placebo-controlled trial evaluated efficacy and safety of high- or low-dose eszopiclone (1 or 2 mg in children aged 6-11 years, 2 or 3 mg in children ages 12-17 years), given every evening, in 486 patients with ADHD-related insomnia. The primary efficacy variable was change in latency to persistent sleep from baseline to week 12, based on polysomnography.

Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome.

Study Objectives: To compare pregabalin versus placebo and pramipexole for reducing restless legs syndrome (RLS)-related sleep disturbance.

Design: Randomized, double-blinded, crossover trial.

Setting: Twenty-three US sleep centers.

Efficacy and safety of doxepin 6 mg in a four-week outpatient trial of elderly adults with chronic primary insomnia.

Introduction: The efficacy and safety of doxepin (DXP), a histamine H(1) receptor antagonist, was evaluated in elderly adults with sleep maintenance insomnia.

Methods: This was a randomized, double-blind, placebo-controlled outpatient trial. Elderly adults meeting DSM-IV-TR criteria for primary insomnia were randomized to four weeks of nightly treatment with either DXP 6 mg (N=130) or placebo (PBO; N=124).

Tasimelteon for insomnia.

Introduction: Insomnia is a prevalent disorder with nearly 50% of the US adult population reporting insomnia symptoms during the past year and 10 - 15% reporting chronic insomnia. In addition, insomnia is a frequent comorbidity with depression, anxiety and pain, as well as other medical and psychiatric disorders. Tasimelteon is a melatonin receptor agonist developed by Bristol-Myers Squibb Co.

Sublingual zolpidem tartrate lozenge for the treatment of insomnia.

Sublingual zolpidem tartrate (SZT) is a sublingual lozenge containing a low dose of the nonbenzodiazepine hypnotic zolpidem tartrate. Pharmacokinetic evaluations suggest that this formulation produces higher drug plasma levels within the first 15-20 min after dosing than the standard oral tablet using only approximately 30% of the standard dose. Published data suggest that SZT is generally safe and effective at rapidly inducing sedation without residual next-day effects, as long as the patient has at least 4 h remaining in bed at the time of administration.

Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies.

Study Objectives: To evaluate the efficacy and tolerability of gaboxadol in the treatment of adult and elderly patients with primary insomnia.

Design: Randomized, double-blind, placebo-controlled, multicenter, 30-night, polysomnography studies.

Setting: Sleep laboratory.

Armodafinil: a new treatment for excessive sleepiness.

Background: Armodafinil is a wake-promoting agent developed by Cephalon that was approved in mid-2007 for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder. It is the R-enantiomer of the compound modafinil. Like modafinil, the mechanism of action for armodafinil is not fully characterized.

Indiplon in the treatment of sleep disorders.

Indiplon is a novel sedative-hypnotic recently approved for the treatment of insomnia. Like other non-benzodiazepine hypnotics, its mechanism of action is to modulate subunits, especially the alpha-1 subunit, of the GABA receptor complex in order to induce sedation. Indiplon was developed in two different formulations to address two different types of insomnia complaint: indiplon-IR (immediate release) was designed for sleep onset difficulties, while indiplon-MR (modified release) was developed for sleep maintenance insomnia.

Indiplon: the development of a novel therapy for the treatment of sleep onset and sleep maintenance insomnia.

Indiplon is a novel non-benzodiazepine sedative-hypnotic that modulates the GABAA receptor complex. It appears to be more selective for the alpha1-receptor subunit, associated with sedation, than other hypnotics. Two different formulations of indiplon have been developed: an immediate release (IR) version targeting sleep onset insomnia and a modified release (MR) version addressing sleep maintenance insomnia.

Wireless CPAP patient monitoring: accuracy study.

The objective of this study was to evaluate the accuracy and reproducibility of a novel method for transmitting continuous positive airway pressure treatment (CPAP) compliance and usage data. Using wireless and Internet technology to transmit/receive clinical data, we examined and compared these data to the same data collected using a traditional flow generator-to-PC interface. Previously diagnosed patients were given commercially available flow generators to use in the home setting for a 30-day period.

Influence of lateral motion transfer on sleep.

This study examined the effects of motion of an artificial bed partner on the sleep of a real subject on the same mattress. A 240-lb eight-sided cylindrical roller served as the artificial bed partner. The roller was placed on one side of a king-size mattress and a normal adult slept on the other half.

Posttraumatic narcolepsy in mild to moderate closed head injury.

Scattered reports exist describing secondary narcolepsy that develops following disease or organic insult to the brain. The present study is concerned with one particular type of secondary narcolepsy, posttraumatic narcolepsy, which we define as "narcolepsy that develops following a head injury in a previously asymptomatic individual". We obtained data on nine patients who had been previously diagnosed with mild to moderate closed head injury and who had unresolved sleep complaints.