domingo, 21 de junio de 2009

MedPage: Armodafinil Rx'd Shift Workers Normalizes Alertness

Medical News from
APSS: Associated Professional Sleep Societies Meeting

http://www.medpagetoday.com/MeetingCoverage/APSS/14780?pfc=101&spc=235

Armodafinil Normalizes Alertness for Shift Workers

By MedPage Today, Staff
Published: June 18, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

SEATTLE, June 18 -- Armodafinil (Nuvigil) brings wake-time sleepiness levels back to normal for symptomatic shift workers after just one night of treatment, researchers found.

In a small randomized clinical trial, patients with shift work disorder were more alert and less prone to napping at night after taking armodafinil compared with placebo, Christopher L. Drake, PhD, of Henry Ford Hospital in Detroit, and colleagues reported here at the Associated Professional Sleep Societies meeting.

The seven-minute improvement in Multiple Sleep Latency Test scores with the wake-promoting drug compared with placebo brought shift work disorder patients back into the normal range, Dr. Drake noted.

By comparison, previous studies had shown only a 1.7- to 3.0-minute improvement on the same test using similar doses of the medication.

Armodafinil -- a longer lasting r-enantiomer formulation of modafinil (Provigil) -- was used at similar doses across studies, but the difference appeared to be the patient populations, he said.

Prior studies have included patients selected as candidates for clinical improvement based on high laboratory values, such as taking less than six minutes to fall asleep during waking hours on the Multiple Sleep Latency Test.

But "shift work disorder patients with a symptom-based diagnosis (i.e., subjective sleepiness) unselected based on the Multiple Sleep Latency Test may respond differently to wake-promoting agents," Dr. Drake's group noted.

So to determine the unbiased response, they conducted a randomized, double-blind, placebo-controlled crossover design study in five patients who met subjective criteria for shift work disorder with excessive sleepiness during waking hours and inability to sleep during sleeping hours.

The participants worked at least 10 night shifts per month. All screened negative for other medical problems or sleep disorders on a daytime polysomnogram at baseline.

Their baseline daytime polysomnography data was consistent with sleep work disorder, the researchers noted. Sleep latency averaged 13.2 minutes with 125.5 minutes spent awake after sleep and a mean sleep efficiency of 70.6%.

After patients received 150 mg of armodafinil or placebo at 11 p.m., they underwent a Multiple Sleep Latency Test with naps throughout their nocturnal "day" at 1:30 a.m., 3:30 a.m., 5:30 a.m., and 7:30 a.m.

Nocturnal sleepiness was significantly less when objectively measured by the mean time to fall asleep during the Multiple Sleep Latency Test after one night of armodafinil treatment compared with placebo (12.65 versus 5.68 minutes, P<0.05).

The study was supported by Cephalon, manufacturer of armodafinil and modafinil.

The researchers provided no information on conflicts of interest.

Primary source: Associated Professional Sleep Societies

Source reference:
Drake C, et al "Armodafinil in shift work disorder: normalization of the MSLT" Sleep 2009; Abstract 32:A34.

Action Points

* Explain to interested patients that shift work disorder can affect people who work irregular, rotating, or night shifts and is characterized by inability to stay alert enough to accomplish daily tasks during waking hours and inability to sleep during sleeping hours.

* Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.