Question:
First effective drug for sleep disorder identified ?
Answer:
First effective drug for sleep disorder identified
In a clinical trial conducted at the University of Illinois at Chicago,
researchers have demonstrated the first promising drug treatment for a
common and life-threatening sleep disorder called sleep apnea.
The drug, an antidepressant called mirtazapine, significantly reduced
the symptoms of sleep apnea.
It cut in half the number of times breathing stopped or slowed during
sleep and reduced the number of times sleep was disrupted by 28 percent.
All 12 patients who participated in the study showed improvement.
"The drug provided the largest benefit and the most consistent
improvement of any pharmaceutical therapy tested in controlled studies
to date," said David Carley, professor of medicine, pharmacology and
bioengineering and director of research at the UIC Center for Sleep and
Ventilatory Disorders.
The results of the trial will be presented this week at the annual
meeting of the Associated Professional Sleep Societies in Chicago by
Carley and co-investigator Dr. Miodrag Radulovacki, professor of
pharmacology and medicine at UIC.
"This has real clinical significance," said Radulovacki. "An estimated
15-20 million people in the United States suffer from sleep apnea, yet
there is currently no cure and no fully effective long-term treatment
for the disorder."
Apnea -- which means "without breath" -- is diagnosed when a person
periodically stops breathing for 10 seconds or more or has episodes of
reduced breathing during sleep. People suffering from sleep apnea may
stop breathing hundreds of times a night, often for a minute or longer.
The disorder is associated with increased risk of high blood pressure,
heart attack, stroke and adult-onset diabetes. Behavioral problems and
cognitive impairments can occur due to insufficient rest.
At present, sleep apnea is treated with mechanical devices, most often
masks or nasal prongs, that maintain a continuous positive airway
pressure.
Such devices are uncomfortable, however, and difficult to use long-term.
The 12 patients in the UIC study were between the ages of 20 and 70.
They received one of two dosages of mirtazapine or a placebo an hour
before bedtime. They were monitored throughout the night in the UIC
Center for Sleep and Ventilatory Disorders after each of three seven-day
treatment periods.
The clinical trial at UIC followed years of laboratory tests of several
classes of medications on a strain of rats that exhibit sleep apneas
similar to the human disorder. Mirtazapine showed the most promise;
other drugs either improved the condition only marginally or made it
worse.
Mirtazapine blocks the activity of a chemical in the nervous system
called serotonin that is involved in regulating mood, emotion, appetite
and sleep.
The UIC study was funded by NV Organon, which markets mirtazapine as
Remeron for the treatment of depression.
Mirtazapine has not been approved by the U.S. Food and Drug
Administration for the treatment of sleep apnea. Its use in this trial
was approved by a UIC institutional review board for experimental
purposes only.
VERY good point. But in my case, correcting the hypothyroid
with Synthroid made absolutely no difference in my sleep apnea
"scores". And having sleep apnea surgery - one round of it,
anyway - actually made my scores worse! Three months after
the Roto-Rooter surgery, my events increased to 59 or 60 per
hour, all central. My obstructive apneas were never that high
in the first place. So, in my case, I'm not sure the surgery was
a good idea.
I absolutely RAN for my
Drug Facts book to check out the drug. What I read kinda made
my enthusiasm tamp down a bit - there are some side-effects
and/or warnings/trials findings that elicited a loud Eeww!
But then, the side effects of sleep apnea get a louder EEWW out
of me. I guess it's one of those situations where you pick your
own poison.
FWIW, the issues with mirtazapine (Remeron) are - to me - kind
of a tossup compared to amitriptyline (Elavil). The mirtazapine
issues are:
• dizziness in about half of the subjects
• nausea in maybe 1%
• only slightly less somnolence than with amitriptyline
• 17% gain weight, as opposed to 6% on amitriptyline
• increases in cholesterol and triglcerides (couldn't find same info
on amitriptyline, not that it might not exist)
• orthostatic hypOtension - and the mention of using mirtazapine
cautiously in patients on high BP meds
• a very small incidence of carcin0genesis in rats fed 12x the high
"adult" human dose, but an unclear relationship of how/if this
applies to humans
• very low incidence of agranularcytosis (infection) that clears up
when the drug is discontinued
