title: Modafinil: new indication. For a minority of patients with sleep apnoea.
abstract: (1) The first-line treatment for patients with troublesome obstructive sleep apnoea syndrome is night-time nasal continuous positive airway pressure, which reduces daytime drowsiness and improves cognitive performance. (2) Modafinil, a non amphetamine psychostimulant already marketed for idiopathic narcolepsy and hypersomnia, is the first drug to be approved in France for the treatment of patients with residual daytime drowsiness despite nasal continuous positive airway pressure treatment. (3) Clinical evaluation of modafinil for this indication consists of two short-term double-blind placebo-controlled trials, lasting 4 and 12 weeks, and including a total of about 500 patients. At a dose of 400 mg/day, 68% of patients experienced an improvement in their daytime drowsiness (usually partial), compared to 37% of patients on placebo. It is not known how many patients no longer had any daytime drowsiness. A major improvement occurred in about 14% of patients (7% on placebo). (4) The main adverse effects of modafinil are neuropsychological (headache, nervousness, insomnia, anxiety, nausea). (5) In short, modafinil is an option to consider when continuous positive airway pressure is not sufficiently effective and when drowsiness continues to significantly interfere with daily activities. However, it only appears to provide a major benefit to about 10% of patients. The only important improvement is in daytime drowsiness, and this is often offset by adverse effects such as headache. Effects of long-term treatment are not known.
mesh_terms: D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D045422:Continuous Positive Airway Pressure; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy*; D004311:Double-Blind Method; D017277:Drug Approval; D005260:Female; D005602:France; D006801:Humans; D020181:Sleep Apnea, Obstructive / Q000188:drug therapy*; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects / Q000502:physiology
chemical_list: D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants