Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study.

Study Objectives: To evaluate the efficacy and safety of oral JZP-110, a second-generation wake-promoting agent with dopaminergic and noradrenergic activity, for treatment of impaired wakefulness and excessive sleepiness in adults with narcolepsy.

Methods: This was a phase 2b, randomized, double-blind, placebo-controlled, parallel-group trial conducted at 28 centers in the United States. Patients were adults with narcolepsy who had baseline scores ≥ 10 on the Epworth Sleepiness Scale (ESS) and baseline sleep latency ≤ 10 min on the Maintenance of Wakefulness Test (MWT).

Clinical perspective: monitoring sodium oxybate-treated narcolepsy patients for the development of sleep-disordered breathing.

Purpose: While the symptoms of narcolepsy are often amenable to treatment with sodium oxybate (SXB), the respiratory effects of long-term SXB treatment have not been systematically studied. Recent reports have implicated SXB with several cases of worsening sleep-related breathing disturbances and accidental death. In addition, these patients are at risk for obesity, which may aggravate co-morbid obstructive sleep apnea.

Dose effects of modafinil in sustaining wakefulness in narcolepsy patients with residual evening sleepiness.

Excessive sleepiness associated with narcolepsy lasts throughout the waking day. The authors conducted two randomized, double-blind studies to compare the efficacy of modafinil once-daily versus split doses in maintaining wakefulness throughout the day. Fifty-six patients received modafinil.

Effect of modafinil on fatigue, mood, and health-related quality of life in patients with narcolepsy.

Introduction: In addition to excessive sleepiness, patients with narcolepsy often have significant fatigue, depressed mood, and decreased quality of life.

Objective: To determine whether treatment with modafinil for excessive sleepiness improves fatigue, mood, and health-related quality of life (HRQOL) in patients with narcolepsy.

Materials And Methods: Outpatients with narcolepsy underwent a 14-day washout of psychostimulants and then were enrolled in this 6-week, open-label, multicenter study.

Efficacy and safety of modafinil for improving daytime wakefulness in patients treated previously with psychostimulants.

Objectives: To assess the efficacy and safety of modafinil for improving wakefulness in narcolepsy patients treated previously with psychostimulants.

Background: Modafinil has become a standard therapy for improving daytime wakefulness in narcolepsy patients and may be a useful therapeutic alternative to psychostimulants used to improve waking function in other medical conditions. Modafinil is chemically dissimilar to and has a pharmacological profile that differs from the psychostimulants.

Dosing regimen effects of modafinil for improving daytime wakefulness in patients with narcolepsy.

In a multicenter, randomized, double-blind study the authors compared the efficacy of modafinil 400 mg once daily, 400 mg given in a split dose, or 200 mg once daily for maintaining wakefulness throughout the day in patients (N = 32) with narcolepsy reporting a positive daytime response to modafinil but late-afternoon/evening sleepiness. Efficacy evaluations included an extended Maintenance of Wakefulness Test (9:00 am to 9:00 pm), the Clinical Global Impression of Change scale, and the Epworth Sleepiness Scale. Modafinil demonstrated significant improvement in wakefulness as assessed by the Epworth Sleepiness Scale compared with placebo at baseline (all P < 0.

Narcolepsy.

Narcolepsy is a severely debilitating neurologic disease that is not as rare as many believe, affecting an estimated 140,000 Americans. Despite the sometimes debilitating nature of narcolepsy symptoms, the disease may go undiagnosed without an organized method for evaluating patients with sleep complaints. Many of the classic symptoms of narcolepsy, such as excessive daytime sleepiness, cataplexy, sleep paralysis, and hypnagogic hallucinations, may be mistakenly associated with other disease states and must be differentiated from other sleep disorders.