New Sleeping Pill Approved
Longer-Lasting Lunesta for All-Night Sleep
Dec. 16, 2004 -- The FDA has approved a new, longer-lasting sleeping
The new pill is Lunesta, formerly known as Estorra. Sepracor, Inc.
manufactures it. Like the currently approved drugs Ambien and Sonata, Lunesta
is a new-generation sleep drug that isn't addictive and doesn't require larger
and larger doses during long-term use.
Clinical trials show that Lunesta helps people get to sleep faster. But its
greatest virtue may be that it helps people sleep through the night. That's a
particular problem for elderly patients suffering from insomnia.
The FDA has approved Lunesta for patients who have difficulty falling asleep
as well as for patients who are unable to sleep through the night.
Ambien and the shorter-acting Sonata have revolutionized the treatment of
insomnia, says Martin B. Scharf, PhD, director of the Center for Research in
Sleep Disorders in Cincinnati, and a psychiatry professor at Wright State
University School of Medicine in Dayton, Ohio.
"Our thinking about insomnia medications is a completely different
animal from what it was in the past. Before Ambien, all of us were in the dark
ages," Scharf told WebMD in a March 2004 interview. "We were reluctant
to treat pain because of these problems with the drugs that we had. What we are
appreciating with these new compounds … is that they can be taken over the long
term. There is no evidence of dependence or need for dose escalation with these
newer medications. It makes more sense to get a good night's sleep than to
worry about these side effects."
Timothy A. Roehrs, PhD, director of research at the Sleep Disorders and
Research Center at Henry Ford Hospital in Detroit, says one major goal for
sleeping pills is to have an effect that lasts for a person's normal sleep time
and then wears off quickly.
"Ambien does do that. It is the most popular current drug," Roehrs
told WebMD in a March 2004 interview. "[Lunesta] has about a six-hour half
life, so it is more likely to maintain sleep. If, specifically, sleep
maintenance is your problem, this might work better than Ambien."
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Indiplon Close Behind
About a year behind Lunesta in the approval pipeline is indiplon, the
yet-to-be-brand-named sleeping pill from Neurocrine Biosciences in partnership
with drug giant Pfizer. Pfizer is a WebMD sponsor.
Indiplon is a short-acting sleeping pill -- but it's being developed in two
formulations: One is meant for use at nearly any time of the night, to help a
person get to sleep quickly; the other has both an immediate-release and
delayed-release component, intended to last throughout the night.
"When you have a compound with just one peak, you get the majority of
the sleep effect at the front end whether you need it or not," Scharf says.
"[Indiplon] works both at front end -- falling asleep -- and later, to help
people stay asleep. Then it wears off before they wake."