SONATA
Sonata is a hypnotic agent used for the short-term treatment of insomnia due to difficulty falling asleep.
American Home Products Corporation’s pharmaceutical division,
Wyeth-Ayerst Laboratories, announced today that Sonata® (zaleplon) has cleared
the final hurdle for U.S. marketing and is being shipped today to distribution
centers across the U.S. This action is possible because the company has received
U.S. Drug Enforcement Administration (DEA) scheduling and is now classified -
like all other prescription sleep medications - as a Schedule IV controlled
substance.
Sonata is now available to patients nationwide.
According to the DEA, a Schedule IV controlled substance is defined as having a
real but low potential for abuse - and if abused, a limited physical or
psychological dependence effect - compared with the substances in other
classifications (Schedules I-III).
The U.S. Food and Drug Administration (FDA) approved Sonata on August 16, 1999
for the short-term (generally 7-10 days) treatment of insomnia in adults,
including elderly patients.
Insomnia affects nearly 84 million Americans, according to the National Sleep
Foundation (NSF). The condition may be caused by a number of factors, including
a change in sleeping or daily environments, such as a new home or job; jet lag;
a new work schedule; pain from arthritis, headache, menstrual cramps, or
backache; stress or anxiety; or use of certain medications.
Sonata is the first in a new chemical class of nonbenzodiazepine (pyrazolopyrimidine)
compounds. It has a unique mechanism of action and pharmacokinetic profile,
which allows for flexible administration (i.e., at bedtime or after difficulty
falling asleep, provided there are four or more hours remaining before becoming
active again).
Sonata is not a sleep maintenance drug. Rather, it remains at its binding site
for only a short time, and is rapidly eliminated after sleep is initiated so the
patient’s natural sleep processes can take over.
In clinical trials, Sonata did not show evidence of next-day grogginess or
"hangover" effects commonly associated with other sleep medications. However,
until patients know how they will react to Sonata or any sleep agent, they
should not engage in activities requiring mental alertness or motor coordination
(e.g. driving or operating machinery).
"Sonata may profoundly impact the way we treat insomnia because it can be taken
on an as needed basis," says Dr. Thomas Roth, Director of the Henry Ford
Hospital Sleep Center, Detroit, MI. "Unlike other prescription sleep medications
that need to be taken in anticipation of sleep problems, Sonata can be taken
either at bedtime or sometime later, after they have tried to fall asleep on
their own, as long as they have four or more hours remaining in bed."
Sonata will be available soon in 5-mg and 10-mg capsules. The recommended dose
for most adults younger than age 65 is one 10-mg capsule; elderly patients are
advised to take one 5-mg capsule.
Zolpidem (Ambien) Versus Zaleplon (Sonata) for Insomnia
A study was conducted by the Zaleplon Clinical Study Group that compared Sonata
(zaleplon) 5mg, 10mg, and 20mg to Ambien 10mg or placebo in a of 615 outpatients
with insomnia. In the beginning of the study, all patients received 7 nights of
placebo, then patients were divided into five groups—each receiving one of the
active drugs or placebo for 28 consecutive nights. At the end of the treatment
period, all patients received 3 nights of placebo. From patient questionnaires,
the authors found that Sonata 10mg and 20mg reduced the time until sleep
significantly more than placebo in all 4 weeks of the study, whereas the 5mg
dose did so in just the first 3 weeks. Sonata 20mg also increased sleep duration
significantly compared to placebo in all but week three of treatment. Ambien
10mg also significantly decreased time until sleep, increased duration of sleep,
and improved quality of sleep compared with placebo. Patients on Sonata showed
no signs of rebound insomnia or withdrawal symptoms after discontinuing the
medication. However, patients on Ambien showed significantly more withdrawal and
rebound insomnia than placebo. Other adverse effects did not differ between
groups.
For 2 weeks, Sonata 5mg or 10mg was compared to Ambien 5 mg or placebo in 549
elderly patients (age 65 years or older) with insomnia. Time until sleep
significantly decreased with Sonata 10mg and Ambien 5mg during both weeks of
treatment, but only in week two for the Sonata 5mg dose. Total sleep time was
significantly increased in week one for Sonata 10mg, but was increased in both
weeks for Ambien. Sonata did not appear to have an effect on number of night
awakenings, but Ambien reduced the number of episodes in both weeks.
Bottom Line
Sonata and Ambien appear to be similar in effectiveness in reducing time until
sleep, however some evidence shows that Ambien may be more effective in
increasing total sleep time and decreasing the number of nighttime awakenings.
Higher doses of Sonata (10mg or 20mg) appear to be more effective than a lower
dose (5mg) without a significant increase in side effects. In one of the above
studies, Ambien caused an increase in hangover effect and rebound insomnia once
the drug was discontinued compared to Sonata.
References:
Elie R, Ruther E, Farr I et al. Sleep latency is shortened during 4 weeks of
treatment with zaleplon, a novel nonbenzodiazepine hypnotic. Zaleplon Clinical
Study Group. J Clin Psychiatry. 1999;60(8):536-44.
Walsh JK, Ancoli-Israel S, Mangano R et al. Zaleplon 5 mg and 10 mg for the
treatment of elderly primary insomniacs. Sleep.1999;22(suppl 1):S341-S342.
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