OT: Lunesta vs generic (Eszopiclone)

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Kennerly
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OT: Lunesta vs generic (Eszopiclone)

Post by Kennerly » Mon Aug 18, 2014 9:44 am

I've been on Lunesta (3mg then 2mg) for quite awhile. I've recently had some mornings when I feel very over medicated, and some nights where it seems I've taken no sleep medicine at all. No significant change in apneas or PAP therapy over this period, but my insurance company did switch my script from the actual Lunesta brand name product over to the generic Eszopiclone not long before this all began. Coincidence? Anyone else have experience with both Lunesta and the generic? TIA.

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JDS74
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by JDS74 » Mon Aug 18, 2014 10:08 am

Two things could be happening.
1. The quality control procedures for the two manufacturers could be different. FDA normally requires that the actual drug content for any medication be within the listed range dose plus or minus some fixed percent. The percent could be as much as 10%.

So, the brand name manufacturer could have the actual dose as 2.2 mg while the generic manufacturer be at 1.9 mg. that's a swing of 20% but both are compliant. It is normal that this percent difference is tightly controlled within one manufacturer so if the OEM is at +10%, they will be consistent. I take Synthroid where the percent is 10% so I have to very careful about generics.

2. It could be that the generic manufacturer's quality control functions are allowing this same kind if swing to occur within their facility.

Check with your insurance company about the cost difference between the generic an a "brand specific" medication. If you can live with the difference, then ask your doctor for a "dispense as written" designation on your scrip.

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Kennerly
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by Kennerly » Mon Aug 18, 2014 10:23 am

JDS74 wrote:Two things could be happening...
Thanks for the quick response JD, very helpful. I have requested that my doc write a "Lunesta only" script so we'll see what happens.

You mention that the manufacturer of the med you take is allowed a 10℅ variance in concentration. Where did you find this info?

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JDS74
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by JDS74 » Mon Aug 18, 2014 10:31 am

This came from my endocrinologist at the tome I started. Since then I have seen it published.

I'll scan around to see if is published anywhere as part of FDA's general regulations.

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Nick Danger
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by Nick Danger » Mon Aug 18, 2014 12:09 pm

JDS is on target with the varying doses being counted as the same dose - I heard the same thing from professors in a psychopharmacology course and a crisis management course. Another thing that could come into play is that you may be having a reaction to one of the "inactive" ingredients in the generic that isn't present in the branded version.

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49er
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by 49er » Mon Aug 18, 2014 12:40 pm

Found this article:

http://fortune.com/2013/01/10/are-gener ... ded-drugs/
But generic drugs diverge from the originals far more than most of us believe. For starters, it’s not as if the maker of the original pharmaceutical hands over its manufacturing blueprint when its patent runs out or is challenged. The patent reveals the components, but it doesn’t explain how to make the drug. In reality, manufacturing a generic requires reverse engineering, and the result is an approximation rather than a duplicate of the original.

The FDA’s rules effectively acknowledge that. The agency’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.
Hmm, maybe that is why I have had such a tough time with meds although of course, I don't know for sure. But generic Lunesta was definitely a disaster as the most it ever gave me in getting back sleep on the machine was 1 hour.

I greatly empathize with Kennerly and hope that the doctor complies with your request for the "real" Lunesta.

49er

JDS74
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by JDS74 » Mon Aug 18, 2014 3:01 pm

Did a little more research on the topic.
Here is a link that discusses the issue of bioequivalance.
Turns out the limits are -20 to +25 or a potential swing of 45%.

In the case in point if the OEM was at +10% and the generic manufacturer was at -20%, then we're looking at a swing of 0.60 mg in dosage which might make the dose ineffective.

http://www.sciencebasedmedicine.org/gen ... quivalent/

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Kennerly
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by Kennerly » Mon Aug 18, 2014 6:18 pm

JDS, 49er and Nick:

Thanks to all three of you for the great responses. And research to boot!

It's all incredibly helpful. Although I had suspicions about the generic version, at the same time the idea just seemed a little too "out there." Now I have a little more confidence that pursuing this may be worthwhile.

49er you mentioned that you personally had a problem with the generic Lunesta. Was it just ineffective or did it cause other problems?

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Re: OT: Lunesta vs generic (Eszopiclone)

Post by JDS74 » Mon Aug 18, 2014 7:44 pm

There is one experiment that you might try before going for the higher cost of the OEM Lunesta. Assuming that the generic is on the low side of dosage even though labeled as 2 mg, you might ask your doctor to prescribe the 3 mg from the same generic source. If that works, then you know the new titrated dose from that manufacturer.

Somewhere on the bottle, is the actual manufacturer's name. Try contacting the pharmacy that supplied it to see if the 3 mg dose generic is from the same company. It is common that a pharmaceutical manufacture has stringent controls so that if one dosage is high or low, all dosages are the same high or low. It is uncommon, but it does happen, that a pharmaceutical manufacturer doesn't control closely so the actual dosage varies even though it meets the FDA bioequivalence standards.

The difference between my copay for generic Synthroid and brand Synthroid is $20 for generic and $94 for brand name. If the Lunesta differences are similar, then it might make some sense to experiment.

Remember, it only makes sense if both generics come from the same manufacturer. Otherwise it really is just a crap shoot and going for the brand name is a better deal.

Good luck.

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Re: OT: Lunesta vs generic (Eszopiclone)

Post by 49er » Tue Aug 19, 2014 2:06 am

Kennerly wrote:JDS, 49er and Nick:

Thanks to all three of you for the great responses. And research to boot!

It's all incredibly helpful. Although I had suspicions about the generic version, at the same time the idea just seemed a little too "out there." Now I have a little more confidence that pursuing this may be worthwhile.

49er you mentioned that you personally had a problem with the generic Lunesta. Was it just ineffective or did it cause other problems?
Hi Kennerly,

I think it was just ineffective.

cby123

Re: OT: Lunesta vs generic (Eszopiclone)

Post by cby123 » Fri Oct 17, 2014 9:33 pm

Stumbled onto this thread.

I've used a CPAP for 10 years, and also have taken Lunesta on and off - the brand name med was great.

But like the OP, my insurance company stopped covering it - at all - and required generic Ambien or Sonata (don't want Ambien, and Sonata doesn't work). Lunesta card only helps if your insurance pays *something*. When the Lunesta generics came out, I thought "Great", and tried it.

Something isn't right - I can't say for sure it's the generic Lunesta - BUT - a question for those of you who've had issues on a generic for Lunesta - who is the manufacturer (on your pill bottle)? Mine is Glenmark.

Thanks,
Jim

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49er
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by 49er » Sat Oct 18, 2014 1:51 am

Interesting Jim. None of the generic hypnotics, including Lunesta, have helped me stay asleep on the pap machine or gotten me back to sleep. But then again, trazadone and elavil didn't work either so I wonder if there is another issue going on that meds aren't going to help with.

Good luck in resolving your issues.

49er
cby123 wrote:Stumbled onto this thread.

I've used a CPAP for 10 years, and also have taken Lunesta on and off - the brand name med was great.

But like the OP, my insurance company stopped covering it - at all - and required generic Ambien or Sonata (don't want Ambien, and Sonata doesn't work). Lunesta card only helps if your insurance pays *something*. When the Lunesta generics came out, I thought "Great", and tried it.

Something isn't right - I can't say for sure it's the generic Lunesta - BUT - a question for those of you who've had issues on a generic for Lunesta - who is the manufacturer (on your pill bottle)? Mine is Glenmark.

Thanks,
Jim

Kennerly
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by Kennerly » Sat Oct 18, 2014 8:09 am

cby123 wrote:
Something isn't right - I can't say for sure it's the generic Lunesta - BUT - a question for those of you who've had issues on a generic for Lunesta - who is the manufacturer (on your pill bottle)? Mine is Glenmark.
Jim my Eszopliclone generics were made by "Dr. Reddy's Lab." (No wonder I had problems -- sounds like a couple of kids playing with a chemistry set out in the garage...)

When I first switched to the generic I thought it seemed a little stronger, then things got pretty weird. There's generally enough weirdness in my life to cast some doubt on any single variable, but I can say that things have been more normal since I went back on the brand name. Going forward I've decided to always evaluate a generic as if it is an entirely different drug. May be worse or better -- the latter has yet to happen for me -- but I expect it to be different until proven otherwise.

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cathyf
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Re: OT: Lunesta vs generic (Eszopiclone)

Post by cathyf » Sat Oct 18, 2014 3:12 pm

Kennerly wrote:Going forward I've decided to always evaluate a generic as if it is an entirely different drug. May be worse or better -- the latter has yet to happen for me -- but I expect it to be different until proven otherwise.
Another thing to be aware of (probably doesn't apply here but just in general) is with drugs which have a time-release mechanism. The chemical ingredients of a drug are in the patent (which anyone can read) but time-release mechanisms are considered trade secrets and every manufacturer has their own. And until very recently the FDA pretty much ignored the issue. This has safety issues as well as efficacy issues, since sometimes the time-release on the dose is to protect against side effects, and "dumping" the whole dose into you all at once might cause big problems that don't happen if your dose gets released gradually into your bloodstream.

Another problem is quality control. I have had issues where one batch from one manufacturer works better than a different batch from the same manufacturer, and had to work with my pharmacist to find a particular generic manufacturer which makes what I need consistently well. The bad news is that the pharmaceutical industry has undergone a huge restructuring in the last couple of years, and so everything any of us "knew" about this or that manufacturer is up for grabs. For example Watson bought Activis, and is doing business going forward under the Activis name. So if you have a generic being made with Activis as manufacturer that used to be made by both companies, is that the old Watson recipe or the old Activis recipe or a new recipe? That could be better or worse!

I'm also with you on the "may be worse or better" part too. The placebo effect is real and measurable, and I can't afford to get myself into the mindset that a drug will work better if it costs more money.

BobRobert

Re: OT: Lunesta vs generic (Eszopiclone)

Post by BobRobert » Fri Oct 24, 2014 8:13 am

I have been taking the name brand lunesta for a long time and the last 6 weeks I have been using the generic, and at first I thought that the generic was stronger as I had a hangover in the mornings, but now I am beginning to think that I have developed a tolerance to the generic which did not happen with the name brand. I am not sure if I slept last night.