New sleep medication

VentdependenT said:

Any of you hear of Estorra? I'm a Sonata guy but I'm always looking for new sleep aids.

Couldn't really find anything about its makeup or how it works.

Vent

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The generic name of Estorra is eszoplicone. I asked a similar question back in March (when it was listed as "approvable" by the FDA) to some psychiatry colleagues, and one who worked outside the U.S. told me this:

"The name Estorra had not rang a bell yet, but now I realize that I had
used Imovane (zopiclone) quite frequently overseas. I assume that the
isomer version will be very similar to the original form, and I ignore
if the rationale for the launching of an isomer in this case is based on
bona fide scientific data and clear clinical benefit, or it is based on
something else...

Zopiclone had the advantage of fast sleep induction (Shortens stage 1,
with delayed REM while keeping REM durantion unchanged) with a longer
half life (up to 6.5 hrs), patients switched from Ambien who would
otherwise wake up at 3 -5 AM, used to report good sleep for 6.5-8 hrs
and no morning sedation. This is of course not considering their primary
diagnoses and treatment. In mood disorders in general I tend to use
Trazodone for symptomatic or medication-related insomnia (or Remeron
etc). So Imovane was not my first choice. For the few patients that
could not tolerate Trazodone, I successfully tried Zopiclone (among
other things, pharmacological and always including behavioral
strategies).

The main side effect which I haven't forgoten was a bitter taste in AM
(I would say 10-25 % patients) and some dry mouth. I also saw in one or
two cases agitation/anxiety and GI distress. But in general, it was very
well tolerated with a lot of symptomatic relief."

To read more about Zopiclone, check out these two links:
www.mentalhealth.com/drug/p30-i01.html
www.biopsychiatry.com/zopiclone.html

Hope this helps.

VentdependenT said:

Any of you hear of Estorra? I'm a Sonata guy but I'm always looking for new sleep aids.

Couldn't really find anything about its makeup or how it works.

Vent

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Both Indiplon and Estorra should win final FDA approval soon. They both are similar structurally to both zolpidem and Sonata, but the early clinical studies (which I haven't read) make the claim that there are less side effects than either Ambien or Sonata. We'll have to wait and see.

I seem to find better anecdotal success in patients staying asleep with Ambien compared to Sonata.

A more interesting question is the management of zolpidem overdose. The literature has case reports stating that slow-infusion flumazenil is an effective antidote, presumably from it's quasi-benzodiazepine structure. Others seem to manage it supportively.

Anasazi23 said:

I seem to find better anecdotal success in patients staying asleep with Ambien compared to Sonata.

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Sonata is very short-acting -- just a few hours. It's designed to be taken if you wake up in the middle of the night, or it's already 2 am and you can't sleep. It doesn't usually work well as a sleep aid when taken at bedtime because it doesn't last long enough.

Ambien is fine, but most people do just as well on trazodone or Restoril, and for a lot less money. They've also both been studied far longer than Ambien. More and more MCOs are also refusing to include Ambien on their formularies because of overprescribing. Personally, I'm just waiting for some big news break that Ambien causes hair loss, or diabetes, or osteoporosis...... (Not that I don't trust the pharmaceutical industry, or anything like that, of course.)

Right, but I'm also scared of Trazodone. Are you concerned with priapism when you prescribe it? I use it a lot in residency too, so I have the concern.

It may not be enough to just tell your patient that he may experience priapism. Do we start reading lists of side effects from all our drugs to every patient? Maybe just the more common ones? The dangerous ones? Who decides how much is common and what are severe, and what are rare? Who's to say that disclosing all these will make you immune to a suit after all?

Look at this:
http://www.cortlandtforum.com/subweb/issues/current_issue/cfweb_medlaw1.htm


or this....
http://www.uspharmacist.com/index.asp?show=article&page=8_1047.htm

Anasazi23 said:

Right, but I'm also scared of Trazodone. Are you concerned with priapism when you prescribe it? I use it a lot in residency too, so I have the concern.

It may not be enough to just tell your patient that he may experience priapism. Do we start reading lists of side effects from all our drugs to every patient? Maybe just the more common ones? The dangerous ones? Who decides how much is common and what are severe, and what are rare? Who's to say that disclosing all these will make you immune to a suit after all?

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I've never had a patient develop priapism. I do warn male patients about it.

I actually have all of my patients sign a generic consent form about the risks of medication and of psychotherapy, which includes all those new FDA warnings about antidepressants. I also always document in my notes, "R/B/A discussed." (Risks/benefits/alternatives.) It's better to do this than to write down exactly what was discussed, because there will always be things you could miss. Some of the time I print out or give them a patient information sheet about the medication(s). If I did that last part all the time, I think I'd be as perfectly protected as you could get.

Nonetheless, no matter what you do, you may get sued if a patient gets injured and looks sympathetic to a jury. There's nothing you can do about it. You have malpractice insurance, they will be happy with you for documenting things well, and they won't have to pay too much if at all. You won't go to jail, you won't be run out of town, and a Medical Board won't yank your license if you didn't do something that was medically inappropriate, illegal, or unethical, regardless of how sympathetic the patient looks.

I wish we had more control over getting sued, but honestly, we don't. A good relationship with your patients is protective, but nothing is perfect. All you can do is try to minimize the damage if -- when -- someone does sue.