Psycho-Babble Medication Thread 532130

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New sleeping pill available in a few weeks?

Posted by ed_uk on August 6, 2005, at 14:25:59

In reply to FDA okays sleep drug Rozerem(TM) (ramelteon), posted by jrbecker on July 23, 2005, at 13:24:47

The manufacturer said Rozerem will be available (in the US) in late August. Is this still true?

~Ed

 

Re: Ramelteon - to zeugma

Posted by zeugma on August 13, 2005, at 6:31:11

In reply to Ramelteon - to zeugma, posted by ed_uk on August 6, 2005, at 13:44:10

> Hi!!!
>
Hi Ed! Please accept this delayed response.
>
> Are you interested in ramelteon? I wondered whether it might be useful in improving your sleep at night without causing a hangover. Perhaps this would reduce your daytime drowsiness...
>
The sleep docs were willing to recommend Xyrem, which sounds like a stronger version of ramelteon. But not for insomnia. I did suffer from severe sleep-onset difficulties that are overcome with NRI's- probably desipramine would work as well as nortriptyline for helping me sleep.
The problem is with how restorative the sleep is. The problem is that I feel like I have a limited quota of energy to divide throughout the week, and if I exert myself on Monday, for example, I will become that much more drained by Wednesday, no matter how early I go to bed in the interim. I don't know if the problem is with sleep per se or if it is a more general problem with CNS activation. I suspect the latter, because prior to treatment with antidepressants, I would feel more activated at sleep onset than I did while fully awake- hence the severe sleep disruption.

Stims work on the other side of the equation to AD's- they do activate me (somewhat) during waking, as opposed to simply deactivating me during sleep. Remember I also have ADHD as well as a sleep disorder, so I do have to work on the waking side of things- I sleep well at night, and one interesting thing about NRI's (Strattera as well as TCA) is that they give me the semblance of a circadian cycle, although they do not help me with many of the processes associated with waking, such as fully engaged perceptual systems (the world is like a blur) and executive function. (Oddly, my perception would intensify at sleep onset, causing the sudden jolting arousals.)

Got to run now, hence the fragmentary nature of this reply.

-z


> Kind regards
>
> ~Ed

 

Re: Ramelteon - to zeugma » zeugma

Posted by ed_uk on August 13, 2005, at 7:58:57

In reply to Re: Ramelteon - to zeugma, posted by zeugma on August 13, 2005, at 6:31:11

Hi Z!

>Please accept this delayed response.

Of course :-)

>The sleep docs were willing to recommend Xyrem.......

Did they suggest that it would enhance the restorative nature of sleep?

~Ed

 

Re: Ramelteon - to zeugma » ed_uk

Posted by zeugma on August 13, 2005, at 13:57:23

In reply to Re: Ramelteon - to zeugma » zeugma, posted by ed_uk on August 13, 2005, at 7:58:57

> Hi Z!
>
> >Please accept this delayed response.
>
> Of course :-)
>
> >The sleep docs were willing to recommend Xyrem.......
>
> Did they suggest that it would enhance the restorative nature of sleep?
>
> ~Ed

Yes, that was the rationale.

-z

 

New sleep drug now available in pharmacies (US)

Posted by ed_uk on September 10, 2005, at 15:38:39

In reply to Re: Ramelteon - to zeugma » ed_uk, posted by zeugma on August 13, 2005, at 13:57:23

Someone just posted to say that ramelteon tablets (Rozerem) are now available in pharmacies in the US.

~Ed

 

Re: New sleep drug now available in pharmacies (US)

Posted by Cecilia on September 11, 2005, at 1:20:54

In reply to New sleep drug now available in pharmacies (US), posted by ed_uk on September 10, 2005, at 15:38:39

Interesting-you see the Lunesta butterfly on TV every day, but I haven`t seen a single advertisement for this. Cecilia

 

Has anyone tried Rozerem yet? (new sleep drug) (nm)

Posted by ed_uk on September 18, 2005, at 13:10:06

In reply to Re: New sleep drug now available in pharmacies (US), posted by Cecilia on September 11, 2005, at 1:20:54

 

ANYONE TRIED AMBIEN CR YET???

Posted by ed_uk on September 18, 2005, at 13:11:41

In reply to Re: Where are all the INSOMNIA sufferers??? » Jakeman, posted by ed_uk on July 27, 2005, at 16:50:45

I'm curious, controlled-release Ambien sounds like a useful med.

~ed

 

Rozerem - no TV advertisements » Cecilia

Posted by ed_uk on September 18, 2005, at 13:24:41

In reply to Re: New sleep drug now available in pharmacies (US), posted by Cecilia on September 11, 2005, at 1:20:54

Hi Cecilia,

The manufacturer of Rozerem has decided that they won't advertise Rozerem on television. They decided that they would only promote their drug to doctors.

~ed

 

Re: Rozerem - no TV advertisements

Posted by Cecilia on September 19, 2005, at 3:50:27

In reply to Rozerem - no TV advertisements » Cecilia, posted by ed_uk on September 18, 2005, at 13:24:41

> Hi Cecilia,
>
> The manufacturer of Rozerem has decided that they won't advertise Rozerem on television. They decided that they would only promote their drug to doctors.
>
> ~ed
>

Amazing-I wonder why. You can`t watch a TV show in the U.S. without learning how to cure everything from your social phobia to your chemotherapy induced fatigue. Of course, the Vioxx and Celebrex ads are gone- I quite miss the Celebrex ladies celebrating in the park and the ice skating champ able to lead her little row of future arthritis-ridden ice skating champs around the rink, thanks to Vioxx. Oh, and the old man who was able to walk his dog to the park with his friends in the morning, thanks to Vioxx. He WAS getting up awful early-perhaps he needs some Lunesta! Cecilia

 

Re: Rozerem - no TV advertisements » Cecilia

Posted by ed_uk on September 19, 2005, at 14:53:17

In reply to Re: Rozerem - no TV advertisements, posted by Cecilia on September 19, 2005, at 3:50:27

It's funny that you have prescriptions drug ads on TV.... we don't have any.

~Ed

 

Re: Drug Ads on TV

Posted by Cecilia on September 20, 2005, at 3:47:31

In reply to Re: Rozerem - no TV advertisements » Cecilia, posted by ed_uk on September 19, 2005, at 14:53:17

> It's funny that you have prescriptions drug ads on TV.... we don't have any.
>
> ~Ed

Well, really it`s crazy that they`re allowed, and probably the number one reason that drug prices are so high. But sometimes they`re more entertaining than the program. First they tell you how wonderful the drug is, then they`re required to list the major side effects and then after telling you how the drug may cause effects such as breaking out with purple polka dots or sudden death they tell you again to ask your doctor about New Super Wonder Drug. I always laugh when they list drowsiness as a "side effect" of sleeping pills-isn`t that the point? Cecilia

 

Re: Drug Ads on TV » Cecilia

Posted by ed_uk on September 20, 2005, at 15:21:01

In reply to Re: Drug Ads on TV, posted by Cecilia on September 20, 2005, at 3:47:31

Hi Cecilia,

I'd quite like to see these ads.

~ed

 

Re: Drug Ads on TV » Cecilia

Posted by Phillipa on September 20, 2005, at 18:27:04

In reply to Re: Drug Ads on TV, posted by Cecilia on September 20, 2005, at 3:47:31

Well then Ed, If we get that new house you can come over and live with us. There is a shortage of pharmacists here. And that way I'd have my own doc in the house. You'd have your own mastersuite upstaris and own full bath and Living area. Love PJ O

 

Re: Has anyone tried Rozerem yet? (new sleep drug)

Posted by Green Willow on September 21, 2005, at 22:01:02

In reply to Has anyone tried Rozerem yet? (new sleep drug) (nm), posted by ed_uk on September 18, 2005, at 13:10:06

I tried Rozerem and it kept me awake all night!!! It made my heart pound and I couldn't sleep. Boy, did I feel like crap the next days. I tried it for several nights, full pill, half pill, whatever - it was horrible for me. Some brands of melatonin do the same thing to me. This was just my experience. I hope if some of you try it that you have better experiences than I did. GW

 

Re: Has anyone tried Rozerem yet? (new sleep drug) » Green Willow

Posted by ed_uk on September 23, 2005, at 16:28:19

In reply to Re: Has anyone tried Rozerem yet? (new sleep drug), posted by Green Willow on September 21, 2005, at 22:01:02

Yuck, it sounds awful. Has anyone else tried it yet????????

~Ed

 

Re: Has anyone tried Rozerem yet? (new sleep drug) » Green Willow

Posted by SLS on September 24, 2005, at 8:05:07

In reply to Re: Has anyone tried Rozerem yet? (new sleep drug), posted by Green Willow on September 21, 2005, at 22:01:02

> I tried Rozerem and it kept me awake all night!!! It made my heart pound and I couldn't sleep. Boy, did I feel like crap the next days. I tried it for several nights, full pill, half pill, whatever - it was horrible for me. Some brands of melatonin do the same thing to me.

Your "paradoxical" reaction to Rozerem (ramelteon) might not be so infrequent with people suffering from depression. I think we will probably see some more of it. Rozerem can even produce depression in vulnerable individuals whom had not been depressed previously.

I am curious as to what kind of depression you have. Is it unipolar typical, unipolar atypical, or bipolar?

Thanks.

I hope your next trial goes better for you. Have you tried Sonata? If your main problem is initiating sleep, and nothing else seems to work, you can pull out the cannon and use Halcion (triazolam). It is the most powerful hypnotic benzodiazepine. I had once used a combination of Halcion + Ativan to deal with severe insomnia produced by treatment with Parnate + desipramine. I took the Halcion to put me to sleep initially and the Ativan would then take over and keep me asleep for the rest of the night. Halcion has such a short half-life that many people will experience a rebound awakening during the early morning hours. Using an adjunct drug with a longer half-life prevents this from happening. Restoril might be better than Ativan to fill this role. Either will work.


- Scott

 

Re: Has anyone tried Rozerem yet? (new sleep drug)

Posted by Green Willow on September 24, 2005, at 16:45:08

In reply to Re: Has anyone tried Rozerem yet? (new sleep drug) » Green Willow, posted by SLS on September 24, 2005, at 8:05:07

Scott,
I don't have depression at all! I have delayed sleep phase syndrome. We were hoping to correct it with a light box and melatonin, but for some weird reason, the melatonin type products make my heart race. It was that my heart was pounding so hard and fast until the junk wore off about 9 hours later that I could not sleep. At least for now, I am going on Lunestra which seems works fine for me. Thanks, Green Willow


> > I tried Rozerem and it kept me awake all night!!! It made my heart pound and I couldn't sleep. Boy, did I feel like crap the next days. I tried it for several nights, full pill, half pill, whatever - it was horrible for me. Some brands of melatonin do the same thing to me.
>
> Your "paradoxical" reaction to Rozerem (ramelteon) might not be so infrequent with people suffering from depression. I think we will probably see some more of it. Rozerem can even produce depression in vulnerable individuals whom had not been depressed previously.
>
> I am curious as to what kind of depression you have. Is it unipolar typical, unipolar atypical, or bipolar?
>
> Thanks.
>
> I hope your next trial goes better for you. Have you tried Sonata? If your main problem is initiating sleep, and nothing else seems to work, you can pull out the cannon and use Halcion (triazolam). It is the most powerful hypnotic benzodiazepine. I had once used a combination of Halcion + Ativan to deal with severe insomnia produced by treatment with Parnate + desipramine. I took the Halcion to put me to sleep initially and the Ativan would then take over and keep me asleep for the rest of the night. Halcion has such a short half-life that many people will experience a rebound awakening during the early morning hours. Using an adjunct drug with a longer half-life prevents this from happening. Restoril might be better than Ativan to fill this role. Either will work.
>
>
> - Scott

 

Re: Has anyone tried Rozerem yet? (new sleep drug)

Posted by jack2000 on September 25, 2005, at 16:31:35

In reply to Re: Has anyone tried Rozerem yet? (new sleep drug), posted by Green Willow on September 24, 2005, at 16:45:08

I have the same reaction you do to melatonin... I was really hoping rozerem would work for me... but im guessing it'll do the same thing to be as it did to you. This is possibly the most frustrating disorder in existence. I have a 27 hr day and absolutely nothing helps it. I am left either feeling exhausted all the time or sleeping 1-2 hrs later every day until i go around the clock completely

 

Re: Has anyone tried Rozerem yet? (new sleep drug) » jack2000

Posted by SLS on September 26, 2005, at 8:25:30

In reply to Re: Has anyone tried Rozerem yet? (new sleep drug), posted by jack2000 on September 25, 2005, at 16:31:35

Hi.

Have you been diagnosed with hypernychthemeral syndrome or DSPS? If not, what, if any, diagnosis have your doctors given you?

Have you ever tried high dosages of vitamin B12 or magnesium? I have seen these mentioned when dealing with chronobiological disorders. Also, reduced exposure to light late in the day might help as some people with DSPS are hypersensitive to light-induced melatonin suppression.

I don't think it is a good idea to avoid Rozerem or agomelatine when it becomes available. Although both drugs are melatonin receptor agonists, I don't think there is enough data on how these drugs work to exclude them from consideration. Perhaps these drugs need to immitate the natural release of melatonin to be effective in chronobiological disorders. That would be at 2:00am for someone trying to keep a 11:00pm - 7:00am sleep schedule. Perhaps very dosage is all that is necessary.

Maybe, maybe, maybe... I know. I'm just thinking out loud. So little is understood about the etiologies and treatments of chronobiological disorders. Perhaps a melatonin antagonist would be of some use if Rozerem exacerbates the situation.

SSRIs can sometimes make things worse.


- Scott

 

ROZEREM (ramelteon) Now Available in Pharmacies

Posted by jrbecker on September 26, 2005, at 11:14:16

In reply to Re: Has anyone tried Rozerem yet? (new sleep drug) » jack2000, posted by SLS on September 26, 2005, at 8:25:30


http://www.marketwire.com/mw/release_html_b1?release_id=96112

ROZEREM(TM) (ramelteon) Now Available in U.S. Pharmacies
First and Only Non-Scheduled Prescription Sleep Medication
LINCOLNSHIRE, IL -- (MARKET WIRE) -- 09/26/2005 -- Takeda Pharmaceuticals North America, Inc. today announced that ROZEREM™ (ramelteon) 8-mg tablets are now available by prescription in pharmacies across the U.S. for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years, and can be prescribed for long-term use in adults.

ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse and dependence in clinical studies. As a result, ROZEREM is not designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). With the exception of ROZEREM, all other prescription medications indicated for insomnia are classified as controlled substances by the DEA, most as Schedule IV drugs.

"The availability of ROZEREM represents the second Takeda-discovered-and-developed product to reach physicians and patients in our brief history," said Mark Booth, president of Takeda Pharmaceuticals North America. "We are excited to be able to offer an important new option for people living with insomnia that has not shown the potential for abuse or dependence."

ROZEREM has a unique therapeutic mechanism of action that selectively targets two receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates 24-hour, or circadian, rhythms including the sleep-wake cycle.

About Insomnia

Approximately 60 million people in the United States suffer from insomnia, yet the vast majority remains undiagnosed and untreated. Insomnia is characterized by difficulty falling asleep, difficulty staying asleep, or poor quality sleep, leading to impairment of next-day functioning.

Insomnia has been linked to a variety of health problems, including obesity, diabetes, hypertension, heart disease and depression. According to the U.S. Surgeon General, nearly $15 billion annually is spent on healthcare related to insomnia, while $50 billion is lost in productivity.

About ROZEREM™ (ramelteon)

ROZEREM™ (ramelteon) is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM can be prescribed for long-term use. ROZEREM should not be used in patients with hypersensitivity to any components of the formulation, severe hepatic impairment, or in combination with fluvoxamine. Failure of insomnia to remit after a reasonable period of time should be medically evaluated, as this may be the result of an unrecognized underlying medical disorder. Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression.

ROZEREM has not been studied in patients with severe sleep apnea, severe COPD, or in children or adolescents. The effects in these populations are unknown. Exercise caution if consuming alcohol in combination with ROZEREM.

ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. ROZEREM should not be taken with or immediately after a high-fat meal. ROZEREM should be taken within 30 minutes before going to bed and activities confined to preparing for bed.

The most common adverse events seen with ROZEREM that had greater than 2% incidence difference from placebo were somnolence, dizziness, and fatigue. For complete prescribing information, please visit www.rozerem.com.

Takeda Pharmaceuticals North America, Inc.

Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, and cholesterol-lowering treatments, and through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease, sepsis, and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.


--------------------------------------------------------------------------------


Contacts:
Jocelyn M. Gerst
Takeda Pharmaceuticals North America
847-383-3696 (office)
847-769-6889 (cell)

Adam Pawluk
Ketchum
646-935-4135 (office)


SOURCE: Takeda Pharmaceuticals North America

 

Re: Has anyone tried Rozerem yet? (new sleep drug) » jack2000

Posted by Green Willow on September 26, 2005, at 13:03:04

In reply to Re: Has anyone tried Rozerem yet? (new sleep drug), posted by jack2000 on September 25, 2005, at 16:31:35

Jack, Do you mean you get the same effect with the heart pounding that I got? If so do you have any idea why that is happening? It strikes me as 9 hour adrenaline rush brought on by melatonin or something, but I am really not sure what is going on. Anyone?

> I have the same reaction you do to melatonin... I was really hoping rozerem would work for me... but im guessing it'll do the same thing to be as it did to you. This is possibly the most frustrating disorder in existence. I have a 27 hr day and absolutely nothing helps it. I am left either feeling exhausted all the time or sleeping 1-2 hrs later every day until i go around the clock completely

 

Is Ambien CR in US pharmacies yet? nm

Posted by jerrympls on September 27, 2005, at 18:07:53

In reply to ROZEREM (ramelteon) Now Available in Pharmacies, posted by jrbecker on September 26, 2005, at 11:14:16

n/m

 

Re: LOL cecilia you are too funny! ; ) (nm) » Cecilia

Posted by fairywings on October 13, 2005, at 10:21:36

In reply to Re: Rozerem - no TV advertisements, posted by Cecilia on September 19, 2005, at 3:50:27

 

Re: Has anyone tried Rozerem yet? (new sleep drug) » Green Willow

Posted by fairywings on October 13, 2005, at 10:24:59

In reply to Re: Has anyone tried Rozerem yet? (new sleep drug), posted by Green Willow on September 21, 2005, at 22:01:02

My p-doc said not to split the pill since it's a time released formula, maybe that caused probs? I havent' tried it yet, but he said they're phasing out Ambien, and it won't be available, or maybe he was saying our ins. wouldn't cover it, but I thought he said they were getting rid of reg. Ambien. I hope I don't have the experience you had with it!

fw


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