Insomnia is the subjective complaint of poor sleep or an inadequate amount of sleep
that adversely affects daily functioning. For the past 4 decades, treatment of insomnia
has shifted away from the use of barbiturates toward the use of hypnotic agents of
the benzodiazepine class. However, problems associated with the latter (eg, next-day
sedation, rebound insomnia, dependence, and tolerance) have prompted development of
other agents.
This review describes the recently approved nonbenzodiazepine agent, zaleplon.
Studies of zaleplon were identified through a search of English-language articles
listed in MEDLINE and International Pharmaceutical Abstracts, with no limitation on
year. These were supplemented by educational materials from conferences.
The efficacy and tolerability of zaleplon have been documented in the literature.
Zaleplon has been shown to improve sleep variables in comparison with placebo. Like
most hypnotic agents, zaleplon can be used for problems of sleep initiation at the
beginning of the night, but its short duration of clinical effect may also allow patients
to take it later in the night without residual effects the next morning. Zaleplon
can be taken < or = 2 hours before awakening without "hangover" effects. It is generally
well tolerated, with headache being the most commonly reported adverse event in clinical
trials (15%-18%). Compared with flurazepam, a long-acting benzodiazepine sedative-hypnotic
agent, zaleplon causes significantly less psychomotor and cognitive impairment (P
< 0.001). Zaleplon has not been studied in pregnant women or children. The dose of
zaleplon should be individualized; the recommended daily dose for most adults is 10
mg.
Insomnia has a substantial impact on daily functioning. If pharmacologic treatment
is indicated for insomnia, the choice of an agent should be guided by individual patient
characteristics.