Monday, December 26, 2005

Gaboxadol for Insomnia

A novel agent, Gaboxadol is being developed for insomnia:
Gaboxadol significantly improved sleep initiation and maintenance while also increasing time spent in restorative slow-wave sleep in an acute phase II placebo-controlled trial, Stephen Deacon, Ph.D., reported at the annual meeting of the Associated Professional Sleep Societies.
Based upon these and other encouraging findings, gaboxadol—first in a novel class of sleep medications known as selective extrasynaptic γ-aminobutyric acid-A agonists, or SEGAs—is now in larger definitive phase III clinical trials, added Dr. Deacon, head of clinical development for sleep disorders at H. Lundbeck, Ltd., Milton Keynes, England.
The benzodiazepine receptor agonists, a class of drugs widely prescribed for insomnia, also target γ-aminobutyric acid (GABA) receptors; however, their action is confined to synaptic GABA receptors. The extrasynaptic GABA-A receptors modulated by gaboxadol are richly present in parts of the brain thought to be important in sleep regulation, he explained.

We are learning more about the GABA-A receptor every day. It will be interesting to see how Gaboxadol compares with the synaptic GABA-A agonists in efficacy and tolerability.

Sunday, December 25, 2005

Preschool Children are not Getting Enough Sleep

A recent study conducted by researchers at Bradley Hospital and Brown Medical School using actigraphy and sleep diaries finds that children under five years of age may suffer from sleep debt as much as older children and adults. The study conducted in the homes of 165 Rhode Island boys and girls between ages 1 and 5 for seven nights of sleep showed that on average children slept 8.7 hours a night and less than 9.5 in a 24-hour period when naps were included. Yet few nap: according to parent diaries, 82 percent no longer nap some or all days after 18 months of age. The amount of sleep found among pre-schoolers in the study contrasts with the 12 to 15 hours pediatric sleep experts recommend for these age groups. The 2005 NSF/Pampers® Baby-Dry™ survey of 1,003 children under 4 years old produced similar findings; on average, the amount of sleep children got each night in the NSF poll was 9.7 hours.
Another element of the Bradley Hospital/Brown Medical School study showed that family characteristics including socio-economic status (SES) significantly contributed to children’s sleep/wake patterns. In families that had lower educational achievement and lower occupational ratings, children were more likely to be out of bed earlier in the morning and spend less time in bed at night; however, these children also had less nighttime awakenings and more sleep efficiency.
"We were very surprised to find how little preschool aged children actually sleep at night," said Acebo. This concerns the authors and sleep experts because studies of school-aged children with poor sleep show lower physical and academic performance and higher rates of parent-reported behavior problems."

Reported by the National Sleep Foundation

Sunday, December 18, 2005

Why I ask patients about insurance status

An anonymous commenter on Kevin, MD wrote:
The first question out of the mouths of nearly all doctor's office staff is "What's your insurance?" I have lost track of how many doctors muse over what to do next and look at my chart murmuring, "What's your insurance?" Yes, they may be figuring out how to best work through the system of my particular insurer, but the net effect is thinking INSIDE the box. I have now taken to telling every doctor EVERY time I see them, "I don't care whether my plan pays for a particular course of action -- I want to know what YOU think is the best thing to do, regardless of cost, and then we'll decide what to do." I am looked at like I'm a Martian, because doctors don't think that way.
In sleep medicine, insurance status is crucial. Most sleep patients are going to need some type of sleep study to evaluate for sleep apnea. Insurance status is very important in properly carrying out and interpreting the sleep study. For example, if a person has Medicare, specific steps need to be taken in order to qualify the patient for the standard treatment of sleep apnea, CPAP. The sleep study pretty much has to be a full-night diagnostic study, rather than a split-night study. Like most insurance companies, Medicare requires an apnea-hypopnea index of at least 5 to qualify for CPAP. However, Medicare has a different definition of a hypopnea than other insurance companies. Medicare requires a 4% oxygen desaturation for hypopneas, most other agencies don't. Recently I had a young patient who I forgot to look up his insurance status before I wrote the orders of his sleep study. It turned out that he had Medicare due to a disability (there are a lot of non-elderly people with Medicare out there, you have to ask). The technician had to spend an additional 45 minutes rescoring the respiratory events to meet Medicare standards and I had to spend an additional 15 minutes reading the study again- Basically a wasted hour because I did not ask about insurance status.
Disclaimer: I have simplified Medicare requirements in the above discussion; it's actually more complicated, especially with the large number of dual-elgibles. This blog does not provide legal advice, you should consult an attorney if you plan on treating Medicare patients.

Wednesday, December 14, 2005

Sleep Boards Part 3

In response to my Dec 9 and 10 posts about the new sleep board examinations, a colleague of mine (and an old friend from residency days), Dr. Eric Clemons, writes (as always my comments will be in regular type, with quotes from Dr. Clemons in italics and color):
I had heard at one point Family Practice did not want to sponsor the ABIM exam as they are planning to offer their own certification to family practitioners. That would explain their reasoning. You are probably right about that.
I think it is unclear at this point what the new certification will mean. For academicians they will likely need this. For those in private practice I suspect the certification by the ABSM will be sufficient for most insurance companies for the foreseeable future and may make obtaining the new certification less of a necessity. I agree that in the short-term most insurance companies will continue to accept ABSM certification. However, I think that by the 2020's most insurance companies will stop accepting ABSM certification. (I plan to retire in the year 2039).
I was under the impression that all current diplomates of the ABSM who are MD's would be eligible to become certified through the practice pathway (and could sit for the first three exams). This would certainly help out your acquaintances and would keep anyone from losing their practices. My understanding was that the practice pathway was for those who did not complete an accredited sleep disorders fellowship. You still have to be board-certified in Internal Med, peds, psych, neuro, or ENT. The practice pathway just gives the candidate a flexible means of documenting sleep medicine experience. There is still a lot of confusion about the requirements for the new sleep boards, and I could be wrong.
Thanks for your comments, Eric

Sunday, December 11, 2005

New Long Term Data on Lunesta

The National Sleep Foundation reports:
A recent study conducted by Thomas Roth, PhD, a sleep researcher at the Henry Ford Hospital in Detroit, James K. Walsh, PhD, executive director and senior scientist at the Sleep Medicine and Research Center at St. Luke’s Hospital in St. Louis and fellow researchers investigated whether eszopiclone (Lunesta™) is effective for the long-term treatment of insomnia. Currently, the median duration of clinical trials evaluating the effectiveness of sleeping pills is one week. While a few studies have tested hypnotic agents for longer, Roth, Walsh and fellow researchers sought to find out how eszopiclone would treat insomnia over a year’s time. The first six months of the trial followed standard trial procedures – double-blind, placebo-controlled and randomized. The second six months the study was conducted "open-label," meaning the drug would be tested under conditions where both researchers and patients knew they were being treated with eszopiclone.
The study of 471 participants ages 21-64 found that eszopiclone was effective and well-tolerated for the length of the study. Researchers saw improvements in both six-month phases of the study, and they argue that the open-label phase was a valuable tool to assess the effectiveness of a medication in a real-life (or clinical) setting. Nevertheless, they note that they did not study what effects discontinuation of the medication would have upon these participants after the one-year trial. While the results of this study indicate that there is the potential for medication to treat chronic insomnia, more research on all areas of treatment for insomnia is necessary. Per the National Institute of Health’s state-of-the-science’s findings, "a substantial public and private research effort is warranted, including developing research tools and conducting longitudinal studies of randomized clinical trials."

I'll comment further on Lunesta when the actual study is published.

Reader Question about Xyrem

A reader (Dozy) asks: Can you talk a bit to how Xyrem is supposed to work? My understanding is it's entirely out of your system in 12 hours after taking it, so how would it help with Cataplexy for the other 12 hours? Xyrem is the only FDA approved treatment for Cataplexy, and has been approved recently for EDS as well. It is the only proven non-stimulant EDS medicine that I'm aware of for the treatment of EDS. For those PWN who have anxiety issues (like me), a non-stimulant approach is vital to functioning. Do you know if other non-stimulant meds are on the horizon?
As far as non-stimulants on the horizon, in 2006 a new version of Provigil, called Nuvigil, that contains only 1 of the 2 isomers (mirror images) of the molecule should be coming out. I think that researchers are also working on treatments that involve hypocretin.
No one is exactly sure how xyrem has its therapeutic effect in narcolepsy. It probably improves sleepiness in narcolepsy by consolidating nocturnal sleep and increasing slow wave sleep. It acts on multiple neurochemical systems. According to Principles and Practice of Sleep Medicine "Most studies to date indicate that the sedative-hypnotic effect is mediated through GABA-B agonist activity". It is also thought to act on the poorly understoon GHB receptor.
I don't know why it has an effect on cataplexy even after it is out of the blood stream- I can only guess that there is still some left in the brain or that it is having some long-lasting effect in the brain. Sorry I can't fully answer your question about xyrem (also known as sodium oxybate and gamma-hydroxybutyric acid)

Saturday, December 10, 2005

Reader Question about the new Sleep Boards

In response to my post about the new Sleep Board examinations, a reader asks "I guess the question is this: do these changes appear to serve any real purpose, or is it just another turf battle?If so, are there really any sleep specialists who need to protect their turf? The ones I know all have ponderous waiting lists."
There is a turf battle going on, but it is not among sleep specialists in private practice. This battle is within academic medicine; The American Board of Medical Specialties and The Accreditation Council for Graduate Medical Education are trying to consolidate their control. The American Board Medical Specialties is trying to eliminate any medical board/examination not under its direct control (such as the American Board of Sleep Medicine, which is an independent board). The Accreditation Council for Graduate Medical Education wants complete control of all residency and fellowship training in the US.
As a sleep specialist in private practice, I am upset that I will have to take the new sleep boards in several years; I am proud to currently be a diplomate of the American Board of Sleep Medicine.
In my earlier post, I mentioned that family practitioners would be inelgible for the new sleep boards. My understanding is that this was by choice of their board, and is not due to conflict with any of the other member boards of the American Board of Medical Specialties.
The American Board of Sleep Medicine is not innocent in all of this; the leadership of the board cooperated in its own destruction.
This post is a departure from the usual professional tone I try to maintain on this blog (I try to save my rants for Rebel Doctor). Please feel free to disagree in the commment section; I may republish some of the disagreements in a regular post.

Friday, December 09, 2005

New Sleep Board Examinations

The American Board of Internal Medicine announces an Added Qualifications Examination in Sleep Medicine. This examination will take the place of the exam offered by the American Board of Sleep Medicine.
The American Board of Internal Medicine, along with the American Board of Psychiatry and Neurology, the American Board of Pediatrics, and the American Board of Otolaryngology, was recently authorized by the American Board of Medical Specialties to offer an Added Qualifications Examination in Sleep Medicine. Representatives from all four Boards will be developing and setting standards for the new examination. ABIM has administrative responsibility for examination development, and the participating/sponsoring boards have responsibility for setting admission criteria for their own diplomates. The examination will be open to diplomates in internal medicine, pediatrics, neurology, psychiatry, or otolaryngology.
The first examination will be administered in fall 2007. Admission requirements for ABIM candidates are being finalized, and confirmed information about the requirements will be available by the fall of 2006.
The Training Pathway for ABIM candidates will require 12 months of satisfactorily completed sleep medicine fellowship training. Sleep medicine fellowship training undertaken July 1, 2009, and thereafter must be accredited by the Accreditation Council for Graduate Medical Education (ACGME). Sleep medicine training undertaken prior to July 1, 2009, must be conducted within a program affiliated with an ACGME-accredited internal medicine or pulmonary disease fellowship program. A Practice Pathway will be available for the first three examinations in 2007, 2009, and 2011. ABIM candidates who have not had formal sleep medicine fellowship training will be eligible to apply through this pathway by documenting certification by the American Board of Sleep Medicine (ABSM) or by documenting the equivalent of 12 months of full-time post-training experience providing clinical care in sleep medicine accumulated over a maximum period of five years prior to application for examination.

Under the old system, most doctors became sleep specialists by completing a residency in any speciality and then completing a fellowship (usually 1 year) in sleep medicine and then taking the examination offered by the American Board of Sleep Medicine.
Those of us who are diplomates of the American Board of Sleep Medicine are now going to have to pay a lot of money (probably $1000 to $2000) to take the new exams. Sleep specialists who are not boarded in psychiatry, pediatrics, neurology, internal medicine or ENT will be left out in the cold. I know several sleep specialists who are boarded in family practice and sleep medicine who will not be able to take the new boards.

Wednesday, December 07, 2005

Rozerem (ramelteon) Update

A reader (shrinkette) asks "I'm hearing a lot from Rozerem reps these days. I now have a Rozerem pen, a Rozerem mug, and some Rozerem notepads. What is your opinion of Rozerem? Thank you
I have prescribed Rozerem several times, but so far only one of the patients has come back for follow-up. She is taking it for primary insomnia, and seems to be doing well on it. She thinks it is comparable in efficacy to Ambien, which she has taken in the past.
Rozerem acts on 2 of the melatonin receptors (MT1 and MT2) while sparing the peripheral melatonin receptor MT3. Melatonin, which hits all 3 receptors, has the theroetical possibility of interfering with puberty/reproductive functioning because of its effect on MT3. MT1 and MT2 are located mainly in the brain, at the suprachiasmatic nucleus.
Melatonin itself is useful for shifting the biogical clock if given at the proper time. However, it is not a good drug for pure insomnia- it has only about 25 % effectiveness for primary insomnia. Why is Rozerem, a melatonin agonist, effective for insomnia while melatonin isn't?? Nobody knows for sure, but it may be because of increased bioavailabilty or because of its ratio of action at the 2 main melatonin receptors.
From what I've heard, Rozerem is a little less effective for insomnia than the benzodiazepines and the benzo agonists (Ambien, Lunesta, Sonata). But it has a good side effect profile and no risk of addiction. Psychiatrists need to be aware that Luvox (fluvoxamine) raises its levels to 50-70x's normal, and therefore Rozerem and luvox should not be prescribed together.
For more about Rozerem, see this site.
There is a lot we don't know about this novel agent for insomnia. But I can tell you one thing for sure: the Rozerem drug reps are giving out great pens. They are long, wide, and easy to write with.

Tuesday, December 06, 2005

Business All-Nighters

The New York Times has an article about business travelers who burn the midnight oil while away on business trips:
"A business trip is not about sleep," said Mr. Stevens, who spends the wee hours in his hotel's lobby or bar, mapping his strategy for the next day. "Nobody comes out of any business meeting and says, 'You did best today because you look freshest.' Clients couldn't care less if I am fresh as a daisy. They just want to know that when I or my team comes to the table, we've got a big idea."
Sleep deprivation eventually catches up with you:
On the other hand, he recalls the time he drifted off while walking down a street - and collided with a parking meter. On another occasion, the lead negotiator on his team fell asleep in midsentence.


A reader (Dozy) asks, Does Ambien affect sleep architecture? If so, how?
Ambien is a benzodiazepine agonist that binds to the alpha 1 subtype of the GABA-A receptor. It is therefore more selective then the benzodiazepines such as valium, ativan, and xanax.
The benzos (valium, etc) tend to increase stage 2 sleep while decreasing deep sleep (stage 3 and 4 ) and decreasing REM sleep. These effects are mild.
Ambien has minimal effects on sleep architecture. In many studies, its effect on sleep stages is no different than placebo. In at least one study, it increased deep (slow wave) sleep.
The brief answer to your question is that, in short-term studies, Ambien decreases sleep latency (time to fall asleep) and increases total sleep time with no significant effect on sleep architecture.

Sunday, December 04, 2005

Reader Questions about Sleep Medicine

For the next 10 days, I am asking for reader questions. Please leave any questions about sleep medicine in the comment section. I will try to answer as many of them as possible. I do not guarantee that I will answer all questions. I may rephrase questions to make it clear that I am not practicing medicine when I answer questions. For example, if someone asks "I have an AHI of 95, what would be the best treatment for me?" I might change that to "what are the best treatments for severe sleep apnea?" in my post. I will leave the original question in the comments section unchanged.

CPAP Supplies

One of my patients recommended that I look at this site, because of the great pictures of CPAP machines and CPAP supplies. (this is not an endorsement of, and not a recommendation to buy CPAP supplies from them).

More about Cardiovascular Disease and Sleep Apnea

On November 20th, I blogged about 2 recent articles in the New England Journal of Medicine. USNews and World Report has a pretty good discussion of these same 2 articles:
People with sleep apnea often don't realize they have it, since they don't remember waking up again and again, gasping for breath. Often, it's a bed partner who hears the choking and "industrial-strength snoring," says Klar Yaggi, a sleep specialist at Yale who led the study. He and his colleagues followed two groups of patients who were tested for sleep apnea (defined as stopping breathing five or more times per hour). Some had the condition; some didn't. During the 3½ years or so that they were studied, the people with sleep apnea were about twice as likely to have a stroke or die.
Another study in the same issue of the New England Journal looked at how well the continuous air treatment works for people with central sleep apnea, a different disorder altogether. In both forms of sleep apnea, you stop breathing periodically. But in central sleep apnea, the problem is not an obstructed airway but that the brain fails to send out the command to breathe. The disorder is usually caused by congestive heart failure, in which the heart doesn't pump as well as it should and fluid collects in the chest.
The treatment did help people with central sleep apnea in some ways: Their hearts worked better, they didn't stop breathing as often, they didn't have adrenaline surges, and they were able to exercise more.
"That's the good news," says Douglas Bradley, a pulmonologist at the University of Toronto and author of the article. "The bad news is that we didn't improve survival."


Another creation for the Somnus Sleep Clinic Website:

A polysomnogram (also know as a PSG) is an overnight sleep study. A PSG is useful in the diagnosis of several sleep disorders, especially obstructive sleep apnea.

Before the test begins, our technicians spend about 45 minutes applying the painless electrodes, sensors, and monitors to the patient.

EEG Electrodes on the scalp are used to monitor brainwaves. Electrodes are also applied to the chin to measure muscle tone and next to the eyes to monitor eye movements. These 3 sets of electrodes are used to determine stage and depth of sleep.

Electrodes are attached to the lower legs to monitor for the leg movements that characterize the disease Periodic Limb Movement Disorder.

To monitor breathing, airflow monitors are placed at the mouth and nose. The monitor at the nose is similar to an oxygen cannula. Belts are placed across the chest and abdomen to detect respiratory effort. These belts are useful in distinguishing between the 2 types of sleep apnea. An oximeter is placed on one finger to detect decreases in oxygen, which are common in obstructive sleep apnea.

Several electrodes are applied to the chest to monitor heart rate and rhythm.

Many patients ask if is possible to get up in the middle of the night during a PSG. It takes a technician only about a minute to help the patient wrap the wires around his neck and get out of bed. Then the patient can easily walk around

A PSG lasts about 8 hours. After the procedure is finished, it takes about 10 minutes to remove the electrodes and sensors. A shower with plenty of shampoo is necessary to remove the electrode gel from the hair!

Friday, December 02, 2005


Bedbugs are back.

The Basics of Narcolepsy

Here is something I have been working on for the Somnus Sleep Clinic website (which is why I wrote it in the 3rd person):

What is Narcolepsy?

Narcolepsy is a sleep disorder resulting in excessive daytime sleepiness. It is often associated with cataplexy. Cataplexy is characterized by sudden emotionally-induced loss of bilateral muscle tone. In many narcoleptics, laughter can provoke an episode of cataplexy. An episode of cataplexy lasts several seconds to several minutes, and often affects the knees, face, or neck.

How is Narcolepsy Diagnosed?

After a history and physical by a sleep physician, further sleep testing is usually required to make a diagnosis of narcolepsy. The key test in the diagnosis of narcolepsy is the multiple sleep latency test (MSLT). This test involves a series of 4-5 nap opportunities during the day. By measuring brain wave activity (EEG), this test measures how long it takes a person to fall asleep, and if a person enters REM sleep (dream sleep) during a nap. During the MSLT, narcoleptics will typically fall asleep within 5 to 8 minutes and enter into REM sleep during at least 2 of the naps. The MSLT can be a difficult test to properly administer and interpret; significant experience on the part of the sleep physician and technical staff is necessary. For more technical information about the proper administration of the MSLT, please see Dr. Rack’s recent comments in The American Journal of Psychiatry (

What Causes Narcolepsy?

Recent research suggests that narcolepsy is an autoimmune disorder. More specifically, narcolepsy is thought to be caused by autoimmune destruction of hypocretin neurons in the hypothalamus (the hypothalamus is an area at the base of the brain important in the regulation of sleep and wakefulness).

How is Narcolepsy Treated?

Sleepiness is usually treated with stimulants (such as Ritalin) or Provigil. Many antidepressants help with cataplexy. Xyrem is helpful for both sleepiness and cataplexy. Behavioral methods, especially brief naps, are also useful in the treatment of narcolepsy.

Where can I find out more information?

Dr. Rack has written extensively about narcolepsy and its treatment in his blog, sleepdoctor ( Much of this information is located at