出版社：Brazilian Association of Sleep and Latin American Federation of Sleep Societies
摘要：Objectives To evaluate safety and effectiveness of 5 mg sublingual zolpidem administered nightly at bedtime, and ‘as needed’ following middle-of-the-night-awakenings; parallel to oral 10 mg. Methods A 3-month, double-dummy, and paralleled trial including five on site visits, from March to November 2013. Patients received three bottles of medication, two to be taken at bedtime (one with active doses and the other with placebo) and the third as rescue medication (either active or placebo). They were randomized in two groups. The oral (OL) group received active doses of oral 10 mg (n¼33), and the sublingual (SL) group active sublingual 5 mg (n¼34). Patients were oriented to allow four additional hours of sleep if using rescue tablets, which were placebo in the OL group. All patients underwent medical evaluation, fulfilled sleep diaries, and sleep quality, insomnia, and sleepiness scales at all visits. Polysomnography (PSG), blood tests, and the Psychomotor Vigilance Test (PVT) were performed twice.
