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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 17 of 17. This is the beginning of the thread.
Posted by Maxime on July 9, 2006, at 21:48:06
Has anyone tried this med? It also goes by the following names and is a TCA.Sinequan, Adapin, Aponal, Poldoxin, Quitaxon, Desidox, Doneurin, Doxal, Doxedyn and Endep.
Anyone?
Did it help you? What were the main side effects?
Thanks.
Maxime
Posted by med_empowered on July 9, 2006, at 21:55:38
In reply to Doxepin?, posted by Maxime on July 9, 2006, at 21:48:06
I've never tried it, but I hear its good for sedation and (presumably) cases where depression and anxiety are mixed.
In general, a lot of docs seem to think that people with more severe and/or resistant cases of depression ("endogenous depressives") respond better to the TCAs that the SSRIs.
Posted by Maxime on July 9, 2006, at 23:10:50
In reply to Re: Doxepin?, posted by med_empowered on July 9, 2006, at 21:55:38
> I've never tried it, but I hear its good for sedation and (presumably) cases where depression and anxiety are mixed.
>
> In general, a lot of docs seem to think that people with more severe and/or resistant cases of depression ("endogenous depressives") respond better to the TCAs that the SSRIs.Yes, if only their side effect profile weren't so long! I need to know if I would gain weight on this med. My anorexia needs to know. ;-)
maxie
Posted by Racer on July 9, 2006, at 23:38:33
In reply to Re: Doxepin?, posted by Maxime on July 9, 2006, at 23:10:50
I took Sinequan for a few days, but it lowered my BP too much for me to stay on it.
Have you tried Desipramine? I've been told it's the least fattening of the TCAs, and I'd consider trying it again myself.
xoxo
Posted by Maxime on July 9, 2006, at 23:41:50
In reply to Doxepin?, posted by Maxime on July 9, 2006, at 21:48:06
Ooops, I added Endep which is not the same thing ... sorry.
maxie
> Has anyone tried this med? It also goes by the following names and is a TCA.Sinequan, Adapin, Aponal, Poldoxin, Quitaxon, Desidox, Doneurin, Doxal, Doxedyn and Endep.
>
> Anyone?
>
> Did it help you? What were the main side effects?
>
> Thanks.
>
> Maxime
Posted by Maxime on July 9, 2006, at 23:45:21
In reply to Re: Doxepin?, posted by Racer on July 9, 2006, at 23:38:33
> I took Sinequan for a few days, but it lowered my BP too much for me to stay on it.
>
> Have you tried Desipramine? I've been told it's the least fattening of the TCAs, and I'd consider trying it again myself.
>
> xoxoYes, I tried it. It made me lactate. Yay!Poop. I hate this. I'm going to send you an email tomorrow when I can sorta think again ... i'm too tired now.
xoxo
Posted by ed_uk on July 10, 2006, at 14:15:39
In reply to Doxepin?, posted by Maxime on July 9, 2006, at 21:48:06
Hi Maxie
Doxepin is one of the most sedating tricyclic antidepressants. It does often cause weight gain.
Doxepin is such a powerful antihistamine that it's sometimes used to treat allergic disorders which have not responded to standard antihistamines.
Love
Ed
Posted by Phillipa on July 10, 2006, at 16:27:39
In reply to Re: Doxepin? » Racer, posted by Maxime on July 9, 2006, at 23:45:21
Pamelor causes you to sleep and I mean sleep. Love Phillipa
Posted by Maxime on July 10, 2006, at 16:29:57
In reply to Re: Doxepin? » Maxime, posted by ed_uk on July 10, 2006, at 14:15:39
Yikes, I won't be trying that one then. I don't along well with sedation. I guess that's why it's used for people with anxiety.
The more I think about it, the more I think that a tall building is the way to go. No more meds. No more anything. Just peace.
Peace,
maxie
> Hi Maxie
>
> Doxepin is one of the most sedating tricyclic antidepressants. It does often cause weight gain.
>
> Doxepin is such a powerful antihistamine that it's sometimes used to treat allergic disorders which have not responded to standard antihistamines.
>
> Love
>
> Ed
Posted by vainamoinen on July 10, 2006, at 18:34:25
In reply to Re: Doxepin? » ed_uk, posted by Maxime on July 10, 2006, at 16:29:57
>
> The more I think about it, the more I think that a tall building is the way to go. No more meds. No more anything. Just peace.
>
> Peace,
> maxie
>
Hope you're kidding, if not...there is hope.And besides woudn't it be a bitch if the Hindu's are right and you are reincarnated into the same or worse predicament and get to do it again.
Posted by Maxime on July 10, 2006, at 21:07:58
In reply to Re: Doxepin?, posted by vainamoinen on July 10, 2006, at 18:34:25
I'm not joking. And yeah, it will be a bitch if I have to go through this hell again, or start over where I left off. It's just a chance I will have to take when I decide what, when and how.
> >
> > The more I think about it, the more I think that a tall building is the way to go. No more meds. No more anything. Just peace.
> >
> > Peace,
> > maxie
> >
> Hope you're kidding, if not...there is hope.
>
> And besides woudn't it be a bitch if the Hindu's are right and you are reincarnated into the same or worse predicament and get to do it again.
Posted by flip_flop on July 11, 2006, at 3:59:12
In reply to Re: Doxepin? » ed_uk, posted by Maxime on July 10, 2006, at 16:29:57
Wouldn't it be better if you tried it first, and then made a decision if it was too sedating or not?
Posted by flip_flop on July 11, 2006, at 4:13:51
In reply to Re: Doxepin? » Racer, posted by Maxime on July 9, 2006, at 23:45:21
> > I took Sinequan for a few days, but it lowered my BP too much for me to stay on it.
> >
> > Have you tried Desipramine? I've been told it's the least fattening of the TCAs, and I'd consider trying it again myself.
> >
> > xoxo
>
> Yes, I tried it. It made me lactate. Yay!Poop. I hate this. I'm going to send you an email tomorrow when I can sorta think again ... i'm too tired now.
>
> xoxoI've read many of your posts and it seems like a lot of meds make you lactate, even meds that doesn't normally have this side-effect. This is a shame, because, if I remember correctly, many of these meds did actually help you.
Have you considered that you may have a medical condition related to the lactation? Maybe you need drugs that normalizes prolactin levels?
Posted by Maxime on July 11, 2006, at 7:55:32
In reply to Re: Doxepin?, posted by flip_flop on July 11, 2006, at 4:13:51
I've had my prolactin levels tested (when not on a med that causes me to lactate) and it is in the normal range.
Maxime
> I've read many of your posts and it seems like a lot of meds make you lactate, even meds that doesn't normally have this side-effect. This is a shame, because, if I remember correctly, many of these meds did actually help you.
>
> Have you considered that you may have a medical condition related to the lactation? Maybe you need drugs that normalizes prolactin levels?
>
Posted by Maxime on July 11, 2006, at 7:58:39
In reply to Re: Doxepin? » Maxime, posted by flip_flop on July 11, 2006, at 3:59:12
I've looked up the chemical make up of the med and it affects histamine in many ways ... it would be very sedating.
But yes, normally I would try a med first. :)
Maxime
> Wouldn't it be better if you tried it first, and then made a decision if it was too sedating or not?
Posted by ttee on July 16, 2006, at 16:25:25
In reply to Re: Doxepin? » flip_flop, posted by Maxime on July 11, 2006, at 7:58:39
Looks like there is a new med on the horizon, which happens to be Doxepin, just in a lower dose. It will be interesting to find out if the ultra low dose (3 mg, or 6 mg) helps as an add on for SSRI induced insomnia. I like the part that "Silenor" didn't have any of the typical TCA, or even compared to Benedryl side effects. I am going to give it a try to help with my Lexapro insomnia. I had my pharmacy order me the generic doxepin liquid. The pharmacy said they can give me a little syringe that will enable me to exactly dose the 3 mg and 6 mg strength. For all those brave, come join me in this experiment.
San Diego, CA – June 9, 2005 -- Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and marketing products for the treatment of insomnia and other neuro-psychiatric disorders, today announced the initiation of patient enrollment in the first Phase III clinical trial of SILENOR™ (doxepin HCl) for insomnia. This multi-center, placebo-controlled Phase III study will evaluate the safety and efficacy of SILENOR™ in adults with primary, chronic insomnia. The primary endpoint of the study is a sleep maintenance measure, Wake After Sleep Onset (WASO) measured by polysomnography (PSG) in a sleep laboratory setting. Multiple secondary endpoints of sleep maintenance, onset and duration will be measured objectively and through patient reported outcomes. Philip Jochelson, MD, Chief Medical Officer of Somaxon commented, “We are excited about the initiation of the Phase III clinical trials of SILENOR™. The product demonstrated encouraging results in our two Phase II dose-finding clinical trials, especially with respect to sleep duration and sleep maintenance. In addition to the primary assessment of sleep maintenance, statistically significant improvements in sleep efficiency were observed at hours seven and eight without demonstrating impairment in measures of next day residual sedation relative to placebo. In addition to this adult Phase III study we anticipate commencing a second Phase III trial later this year in an elderly population with insomnia.” Ken Cohen, President and CEO of Somaxon commented, “We believe SILENOR™ offers the potential to provide patients suffering from insomnia and the physicians who treat them with a highly differentiated treatment option. In addition to its emerging clinical profile, SILENOR’s ™ active ingredient is not a Schedule IV controlled substance and its mechanism of action is different from all currently approved products for the treatment of insomnia. Our recently completed $65 Million financing will allow us to advance the SILENOR™ Phase III program through its next clinical milestones.” Somaxon recently completed two randomized, double blind placebo-controlled dose-finding Phase II trials with SILENOR™, one in adults and one in elderly
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patients with primary sleep maintenance insomnia. In those trials, SILENOR™ produced statistically significant improvement in sleep maintenance measures such as WASO, sleep duration measures such as Total Sleep Time (TST), and sleep induction measures such as Latency to Sleep Onset (LSO). About Somaxon Headquartered in San Diego, Somaxon Pharmaceuticals is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of insomnia and other neuro-psychiatric disorders. The company has several product candidates in development. The most advanced clinical program focuses on the evaluation of SILENOR™ (doxepin HCl) for the treatment of insomnia, a condition that, according to the National Sleep Foundation’s Sleep in America Poll, affects more than 70 million Americans. These problems tend to worsen with age. Two-thirds of adults aged 55-84 report experiencing sleep problems a few or more nights a week Phase III clinical trials of SILENOR™ for the treatment of insomnia commenced in the second quarter of 2005.A Phase II clinical trial with oral nalmefene for the treatment of pathological gambling was completed by Somaxon’s strategic partner, BioTie Therapies Corp. in 2003. Somaxon intends to initiate a double-blind, randomized, multi-center Phase II/III clinical trial in 2005 for the use of oral nalmefene for the treatment of pathological gambling, a growing health concern that has been recognized in the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association since 1980. It is estimated that in North America there are approximately 3 million pathological gamblers according to the National Gambling Impact Study Report. Pathological gambling is designated as an Impulse Control Disorder (ICD) which also includes pyromania, kleptomania, and intermittent explosive disorder. Pathological gambling and other ICDs represent significant unmet medical needs, with no approved drug therapy to treat these disorders. The company also intends in 2005 to initiate a Phase II proof of principle study with oral nalmefene for the treatment of nicotine dependency.The company also has in-licensed the worldwide rights to the use ofacamprosate, a GABA-A agonist and NMDA antagonist, for the treatment of movement disorders and other conditions and has initiated product developmentwork on this compound. For more information, please contact Ken Cohen, President and CEO (858.509.3670) or visit the company’s web site at www.somaxon.com.
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Somaxon cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertaintiesinherent in Somaxon’s business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its product candidates that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its product candidates; competition from other pharmaceutical or biotechnology companies; and its ability to complete subsequent closings of the Series C preferred stock financing or obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement and Somaxon undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Posted by ttee on July 16, 2006, at 16:28:34
In reply to Re: Doxepin?, posted by ttee on July 16, 2006, at 16:25:25
I attached the wrong Silenor article in my last post. Sorry. Here is the better one ---->
Phase 3 Data Show New Insomnia Drug, Silenor™, Effective Without Side Effects
12 Apr 2006Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), today announced positive results from its initial Phase 3 clinical trial with the tested doses of 3 mg and 6 mg of SILENOR™ (doxepin HCl), achieving statistically significant results in adults with chronic insomnia. Results of the primary endpoint for this trial, 8-hour Wake After Sleep Onset (WASO), which is an objective measure of sleep maintenance using polysomnography (PSG) in a sleep laboratory setting, were significant for both doses. SILENOR™ demonstrated improvement in mean WASO of 26 minutes for 3 mg (p<0.0001) and 31 minutes for 6 mg (p<0.0001) versus placebo for the primary analysis. Statistical significance versus placebo was maintained at both doses for all time points.
Improvement on Total Sleep Time (TST) was statistically significant (p<0.0001) for both doses at the initial treatment period, increasing from 374 minutes for placebo to 415 minutes for SILENOR™ 3 mg and 421 minutes for SILENOR™ 6 mg. After four weeks of nightly administration, improvement in TST remained statistically significant for both doses relative to placebo. Sleep Efficiency (SE) demonstrated results that were significant and consistent with those observed for TST. In the final third of the night, SILENOR™ generally demonstrated statistically significant improvement in Sleep Efficiency versus placebo for each dose.
SILENOR™ demonstrated a statistically significant reduction in Latency to Persistent Sleep (LPS) for both doses at the initial treatment period. Compared to LPS for placebo of 45 minutes, both 3 mg and 6 mg SILENOR™ reduced LPS to 27 minutes (p=0.011 and p=0.0018, respectively). These differences were not observed at subsequent time points, largely due to an improvement in LPS in the placebo group.
Both doses of SILENOR™ were well tolerated. Side effects in the SILENOR™ groups were comparable to placebo and there were no statistically significant differences versus placebo in next day residual measures.
There was no evidence of tolerance to SILENOR™ over the treatment period and sleep architecture was preserved. Rebound insomnia, withdrawal effects, memory impairment, weight gain and anticholinergic effects were not observed.
Commenting on the clinical results, Tom Roth, Ph.D., Chief, Division Head, Sleep Disorders & Research Center, Henry Ford Hospital, stated, “In patients with chronic insomnia, doxepin 3 mg and 6 mg demonstrates significant improvements in sleep across four weeks of nightly administration. These findings occurred in the absence of rebound insomnia, amnesia and next day residual effects with a low incidence of adverse events.”
Ken Cohen, President and CEO of Somaxon stated, “We are very encouraged by these results. We are undertaking a comprehensive Phase 3 program that has the potential, if successful, to establish SILENOR™ as a first line treatment for patients with insomnia. Results from the clinical trial, coupled with the mechanism of action which is distinct from benzodiazepine and non-benzodiazepine products for insomnia, creates an opportunity for differentiation in the market. We look forward to reporting results from the remaining Phase 3 clinical trials later in 2006 and to filing an NDA in the first quarter of 2007.”
Study Design
This trial was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multi-center 35-day study designed to assess the efficacy and safety of 3 mg and 6 mg dose levels of SILENOR™ in adults with primary insomnia characterized by sleep maintenance difficulties in a sleep laboratory setting. This trial enrolled 229 adult male and female patients with chronic primary insomnia as defined by the Diagnostic and Statistics Manual, Fourth Edition.
About SILENOR™
SILENOR™ is a low-dose (1 mg, 3 mg, 6 mg) oral tablet formulation of doxepin hydrochloride that is patent protected for its use in insomnia. Doxepin has been prescribed for more than 40 years for the treatment of depression and anxiety at dosages typically ranging from 75 mg to 300 mg per day. Though established as an effective antidepressant, at high doses, doxepin is known to have a range of undesirable side effects including daytime sedation and drowsiness, dry mouth, dry eyes and other anticholinergic effects. However, at the low doses used in SILENOR™ in controlled clinical trials conducted by Somaxon, these side effects have not been observed.
Unlike most approved insomnia medications, SILENOR™ does not act via a set of brain receptors known as the benzodiazepine, or GABA, receptors. Drugs that act on these receptors have been associated with amnesia, hallucinations, dependency and addiction. The U.S. Drug Enforcement Agency classifies these products as Schedule IV controlled substances and carefully monitors and controls their prescribing and use. Although the mechanism of action for the sleep-promoting effects of SILENOR™ is not definitively known, it differs from the currently available sleep-promoting agents in that the effects are mediated through the histaminergic system. The active ingredient in SILENOR™, doxepin HCl, is known to be a highly potent histamine antagonist. Histamine blocking has been demonstrated to reduce wakefulness and is thought to promote the initiation and maintenance of sleep.
While SILENOR™ has been demonstrated to be a potent blocker of H1, at the low doses that are being investigated for insomnia, it does not appear to exhibit the unwanted side effects noted at higher doses of doxepin or similar side effects evident with drugs like diphenhydramine.
About Insomnia
Nearly 70 million American adults are affected by insomnia - characterized by difficulty falling asleep, waking frequently during the night, waking too early and not being able to return to sleep, or waking up not feeling refreshed.
Results from a 2005 National Sleep Foundation Sleep in America poll reported that respondents experienced the following insomnia symptoms:
-- 54% experience insomnia symptoms a few nights a week;
-- 21% have difficulty falling asleep (sleep onset);
-- 32% awake often during the night (sleep maintenance); and
-- 21% wake up too early and can not get back to sleep (premature final awakening).
This is the end of the thread.
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