Medscape
by Yael Waknine, February 2006
Modafinil Approved for Shift Work Sleep Disorder in Canada
Feb. 27, 2006 — Health Canada has approved a new indication for
modafinil, allowing its use for the symptomatic treatment of excessive
sleepiness in shift work sleep disorder; the Swedish Medicinal Products
Agency has approved a new indication for a natural human alpha-interferon
injection, allowing its use for the adjuvant treatment of high-risk melanoma
after excision and dacarbazine therapy; and the European Commission has
approved an expanded indication for inhaled ciclesonide, allowing its
use for the treatment of persistent asthma in adolescents aged 12 years
and older.
Modafinil (Alertec) for Shift Work Sleep Disorder in Canada
On February 14, Health Canada approved a new indication for modafinil
(Alertec tablets, made by Shire BioChem, Inc), allowing its use for the
symptomatic treatment of excessive sleepiness in shift work sleep disorder.
The approval was based on data from a double-blind, 12-week study in
209 patients showing that nightly treatment with 200 mg of modafinil increased
sleep latency from baseline (1.7 ± 0.4 vs 0.3 ± 0.3 minutes;
P = .002) and improved clinical symptoms in a greater proportion of patients
(74% vs 36%; P < .001) compared with placebo.
Modafinil-treated patients also experienced a decrease from baseline
in the frequency and duration of attention lapses during nighttime testing,
contrasting with the increase observed among those receiving placebo (Psychomotor
Vigilance Test score, –2.6 vs 3.8; P < .001).
In addition, patients receiving modafinil therapy reported fewer accidents
or near misses while driving home from work compared with those receiving
placebo (29% vs 54%; P < .001).
The most commonly reported adverse events associated with modafinil therapy
were headache (25%) and nausea (9%). Treatment did not adversely affect
daytime sleep compared with placebo.
Although 200 mg of modafinil reduced the extreme sleepiness
of chronic shift work sleep disorder and resulted in small but significant
improvements in performance compared with placebo, patients continued
to have residual sleepiness and impaired performance at night. This finding
suggests that the therapy is not completely effective and underscores
the need for development of more effective interventions.
Modafinil tablets (marketed by Cephalon, Inc, as Vigil and Provigil)
were previously approved for this indication by the UK Medicines and Healthcare
Products Regulatory Agency, Germany's Federal Institute for Drugs and
Devices, and the US Food and Drug Administration (FDA).
Modafinil tablets are also approved by the FDA and Health Canada to improve
wakefulness in patients with excessive sleepiness associated with narcolepsy
and obstructive sleep apnea/hypopnea syndrome.
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