Evidence for new indications for modafinil is lacking, says DTB
There is little published evidence to justify the use of modafinil (Provigil) for the treatment of excessive sleepiness associated with chronic disease or shift work, according to the latest Drug and Therapeutics Bulletin.
Modafinil, which was previously indicated for daytime sleepiness associated
with narcolepsy or obstructive sleep apnoea syndrome, was licensed for
the treatment of
excessive sleepiness associated with other chronic pathological
conditions and chronic shift work disorder earlier this year (PJ, 10
April, p438).
However, the DTB states that data from trials involving people who had
shift work disorder that suggested the drug can improve quality of life
need confirmation. It suggests that modafinil be compared with other
strategies for alleviating the problems associated with shift work, such
as scheduled naps, bright light therapy and caffeine.
The DTB points out that while modafinil has been shown to reduce daytime
sleepiness in patients with sleep apnoea, it has also been shown to reduce
patients’ use of continuous positive airway pressure therapy.
This therapy is used by patients with obstructive sleep apnoea to prevent their
throat closing during the night. Reduction in its use could potentially be harmful.
The DTB says that any use of modafinil in this disorder must not substitute or
reduce the use of CPAP therapy.
Regarding the use of modafinil in narcolepsy, the DTB acknowledges that the drug
can benefit patients and appears to cause fewer unwanted effects than dexamfetamine.
However, it states that modafinil has not been tested against dexamfetamine and
that dependence with long-term use of modafinil has not been ruled out.
Wherever possible the underlying cause of excessive daytime sleepiness should
be identified and remedied (2004;42:52).
Sildenafil still first
choice This month’s DTB also
states that sildenafil (Viagra) remains the first-line drug treatment
for men with erectile dysfunction despite the introduction of apomorphine
(Uprima), tadalafil (Cialis) and vardenafil
(Levitra). The DTB says that the limited published evidence available
suggests that apomorphine improves erectile dysfunction but is less effective
than sildenafil. Tadalafil and vardenafil improve erectile function and appear
to be relatively well tolerated but it is not known how they compare with each
other or with sildenafil.
The DTB also says that evidence suggesting that men prefer tadalafil
to sildenafil
is weak (ibid, p49).
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