Posted by azalea on October 30, 2008, at 14:30:50
In reply to Re: bad sleep- sleep fragmentation and Slow Wave » azalea, posted by rotem on October 30, 2008, at 10:48:41
According to the study below, modafanil (generic name for Provigil) does not affect sleep architecture as measured by polysomnography.
J Clin Sleep Med. 2007 Oct 15;3(6):595-602.Evaluation of the safety of modafinil for treatment of excessive sleepiness.
Roth T, Schwartz JR, Hirshkowitz M, Erman MK, Dayno JM, Arora S.
Henry Ford Sleep Disorders Center, Detroit, MI 48202, USA. TRoth1@hfhs.org
STUDY OBJECTIVES: Modafinil is a wake-promoting agent shown to improve wakefulness in patients with excessive sleepiness (hypersomnolence) associated with shift work sleep disorder, obstructive sleep apnea, or narcolepsy. Safety and tolerability data from 6 randomized, double-blind, placebo-controlled studies were combined to evaluate modafinil across these different patient populations. METHODS: One thousand five hundred twenty-nine outpatients received modafinil 200, 300, or 400 mg or placebo once daily for up to 12 weeks. Assessments included recording of adverse events and effects of modafinil on blood pressure/heart rate, electrocardiogram intervals, polysomnography, and clinical laboratory parameters. RESULTS: Two hundred seventy-three patients with shift work sleep disorder, 292 with obstructive sleep apnea, and 369 with narcolepsy received modafinil; 567 received placebo. Modafinil was well tolerated versus placebo, with headache (34% vs 23%, respectively), nausea (11% vs 3%), and infection (10% vs 12%) the most common adverse events. Adverse events were similar across all patient groups. Twenty-seven serious adverse events were reported (modafinil, n = 18; placebo, n = 9). In modafinil-treated patients, clinically significant increases in diastolic or systolic blood pressure were infrequent (n = 9 and n = 1, respectively, < 1% of patients). In the studies, 1 patient in the modafinil group and 1 in the placebo group had a clinically significant increase in heart rate. New clinically meaningful electrocardiogram abnormalities were rare with modafinil (n = 2) and placebo (n = 4). Clinically significant abnormalities in mean laboratory parameters were observed in fewer than 1% of modafinil-treated patients at final visit. Modafinil did not affect sleep architecture in any patient population according to polysomnography. CONCLUSIONS: Modafinil is well tolerated in the treatment of excessive sleepiness associated with disorders of sleep and wakefulness and does not affect cardiovascular or sleep parameters.> but Providgil is a stimulant, so it can increase restlessness and sleep fragmentation.
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> I'm tired throughout the day, because my sleep is not efficient. I spent 8 hours, but this is not a quality refreshing sleep.
poster:azalea
thread:859889
URL: http://www.dr-bob.org/babble/20081027/msgs/859948.html