Somaxon Pharmaceuticals Announces Positive Results in a Phase II Dose-Finding Study of Low -Dose Doxepin in Elderly Patients with Primary Sleep Maintenance Inso

In January we reported positive data on a similar
dose-finding study in adults with primary sleep maintenance insomnia."

Study Design

The Phase II study was a randomized, multi-center, double-blind,
placebo-controlled , four-way cross-over, dose response study of 71 per
protocol elderly patients aged 65-84 years who were diagnosed with
primary chronic sleep maintenance insomnia."

"Thank you for raising my level of awareness," Fred declares at the show's
conclusion.

adjustment anxiety

0001 for 1 mg, 3 mg and
6 mg). Doxepin, unlike all FDA
approved products for the treatment of insomnia is not a Schedule IV
controlled substance. Sleep maintenance insomnia is a significant
problem. SPECT technology is the most affordable, revealing brain
imaging process available today. SPECT imaging not only identifies the location of brain-based
(neurological) disorders, but also identifies other possible brain
dysfunctions which may be complicating the primary pathology.

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About Insomnia

Insomnia is a growing health problem in the United States. The company
has several product candidates in development.

PRESS RELEASE Dr. Phil and Brain Matters Imaging Centers Expand Treatment Considerations for Troubled Guest

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Actual results may differ
materially from those set forth in this release due to the risks and
uncertainties inherent 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 obtain additional
financing to support its operations .

In Brain Matters Imaging Centers' first appearance on the nationally
televised program last January, Dr. For example,
an unrecognized traumatic brain injury can make depression more difficult
to treat.

inability factitious

We expect our first Phase III trial to commence by the
middle of 2005.

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Three dose levels of
doxepin (1 mg, 3 mg, 6 mg) were assessed in a PSG sleep laboratory
setting.

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The company anticipates that Phase III clinical trials
evaluating low doses of doxepin for insomnia will begin in mid 2005 ." Fred has Bipolar II disorder and wants more
control over his life.

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In all dose groups, there were no differences in adverse
events and no statistically significant next day residual effects with
low-dose doxepin versus placebo.

Results

Doxepin 1 mg, 3 mg and 6 mg demonstrated statistically
significant improvement in the primary endpoint by
polysomnography (PSG)-defined Wake Time During Sleep (WTDS)
vs. Somaxon is planning to initiate studies of oral nalmefene
in both pathological gambling and nicotine dependence in 2005.

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in 2003.

traumatic impulse

Latency to Sleep Onset (LSO) demonstrated statistical
significance vs.
On the basis of these encouraging results, we are preparing to enter
Phase III clinical trials in which we will evaluate the safety and
efficacy of low-dose doxepin in both adult and elderly patients with
insomnia. Safety and tolerability were also assessed.

SPECT (Single Photon Emission Computed Tomography) technology is a
high-definition evaluation tool that helps identify conditions such as traumatic brain
injury (TBI),
seizures, stroke, Alzheimer's and
other dementia processes, ADHD, OCD, depression, bipolar
disorders, anxiety,
Tourette's Syndrome and Autism Spectrum
Disorders.

emotions neurodevelopmental

placebo in
Subjective Total Sleep Time (sTST), and Subjective Wake After
Sleep Onset (sWASO).

Sleep Quality (SQ) was also statistically significantly
improved for all dose groups.

Impulse
Control disorders are similar to other addictions and include
pyromania, kleptomania, and intermittent explosive disorder.
Pathological gambling and other ICDs represent a significant unmet
medical need as there is no approved drug therapy to treat these
disorders." "But
the disorders are not you.

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Low-dose doxepin also demonstrated efficacy in all
secondary sleep maintenance endpoints as well as patient reported
outcomes.

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Somaxon President and Chief Executive Officer Ken Cohen stated,
"We are extremely pleased with the results from our second Phase II
study with low-dose doxepin in elderly patients with sleep maintenance
insomnia.

About Doxepin

Doxepin HCL is a tricyclic compound currently approved for the
treatment of depression. Pathological gambling is 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.somaxon."
(Click here for details)
In this follow-up appearance, Ms.

Often the erratic behavior of people suffering from neurological disorders
is blamed on psychological or personality weaknesses when the problem is
biological.

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placebo.

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placebo (p less than or equal to 0.
For more information, please contact Ken Cohen, President and CEO
(858-509-3670) or visit the company's web site at www.

delusional disorders

Doxepin 1 mg, 3 mg, and 6 mg demonstrated statistically
significant improvement in the secondary endpoints of
PSG-defined Wake After Sleep Onset (WASO), Sleep Efficiency
(SE) and Total Sleep Time (TST) vs.

Latency to Persistent Sleep (LPS) showed a dose-dependent
reduction, though not statistically significant vs.

About Somaxon Pharmaceuticals

Headquartered in San Diego, Somaxon Pharmaceuticals is a specialty
pharmaceutical company focused on developing and commercializing
products for the treatment of neuro-psychiatric disorders. The most advanced
clinical program focuses on the evaluation of low-dose doxepin for the
treatment of insomnia, a condition that, according to the National
Sleep Foundation's Sleep in America Poll affects more than 50 million
Americans. "You've also raised my level of self-esteem.

adolescent emotions

Phil Show ."

About Brain Matters Inc.

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The primary endpoint was Wake Time During Sleep (WTDS).

disorders feelings

Pathological
gambling is designated as an Impulse Control Disorder (ICD).

This category is concerned with disorders, conditions and syndromes in the mental health area listed by type and with mental health support groups.

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Business Editors/Health/Medical Writers
BIOWIRE2K

SAN DIEGO----Somaxon
Pharmaceuticals Inc.

Doxepin demonstrated statistical significance vs. In
February, Fred was flown to BMIC's Denver location and received a
state-of-the-art brain scan and clinical evaluation courtesy of the "Dr.

disorders mood

It is
believed that more than 10 million people suffer from chronic insomnia
and up to an additional 50 million people suffer from some form of
insomnia each year. In the National Sleep Foundation's Sleep in America Poll
2005, 42 percent of survey respondents reported they awoke frequently
during the night, 22 percent of adults report waking too early and not
being able to return to sleep and 38 percent surveyed reported waking
and feeling unrefreshed. The inclusion of forward-looking
statements should not be regarded as a representation by Somaxon that
any of its plans will be achieved. Phil Show: Extreme Highs and Lows.

madi schizophrenia

placebo. placebo in one dose group. The recommended daily dose for the treatment
of depression ranges from 75 mg to 300 mg.
The Company also has in-licensed the worldwide rights to the use
of acamprosate, a GABA-A agonist and NMDA antagonist , for the
treatment of movement disorders and other conditions and is initiating
product development work on this compound. In addition
to confirmation of his prior bipolar diagnosis, the SPECT scan also
captured blood flow patterns and brain activity consistent with anxiety and
traumatic brain injury, which was not previously identified.

"It's good news," said Dr.

delusional traumatic

, a specialty pharmaceutical company focused on
developing and marketing products for the treatment of
neuro-psychiatric disorders , today announced that low-dose doxepin
demonstrated statistically significant results in a Phase II
dose-finding study in elderly patients with primary sleep maintenance
insomnia. Low-dose doxepin demonstrated efficacy in its primary
endpoint, Wake Time During Sleep (WTDS) at all doses studied , 1 mg, 3
mg and 6 mg. Among
the secondary endpoints measured were Wake After Sleep Onset (WASO ),
Total Sleep Time (TST), Wake Time After Sleep (WTAS) as well several
patient reported outcomes .
A Phase II clinical trial with oral nalmefene for the treatment of
pathological gambling was completed by Somaxon's strategic partner,
BioTie Therapies Corp.com

Somaxon cautions you that statements included in this press
release that are not a description of historical facts may be
forward -looking statements.
"The disorders are things going on in your
brain," Nancy Goodhue, co-founder of Brain Matters Imaging Centers
tells Fred on the March 7th "Dr. Goodhue, Chief Clinical Officer of Brain
Matters Imaging Centers, reviews the SPECT findings for Fred. And here we see what can be addressed
in terms of learning to control such things as anxiety and blood flow, and
knowing the right kinds of medications.

functioning delusional

Greg Hipskind, Senior Medical Advisor,
addressed the importance of SPECT brain-imaging
technology to a more comprehensive assessment of brain-based disorders. Phil, "because 50 percent of the solution to any
problem lies in defining the problem.

somatoform anxiety

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.