Somaxon Pharmaceuticals, Inc. ("Somaxon," "us" or "we") maintains the website(s)
including, but not limited to, www.silenor.com
(collectively, the "Somaxon Websites"). By accessing and/or using the Somaxon Websites,
to use the Somaxon Websites. Somaxon reserves the right to change or update these
means you agree to comply with any changes.
I. Product and Medical Information.
Nothing contained on the Somaxon Websites is intended as a promotion of any product
or recommendation for the use of any product in a way which conflicts with the laws
and regulations of the country in which you are located. The medical information
and other Somaxon Content (as defined below) provided on the Somaxon Websites is
intended for general educational purposes only and is not intended as a substitute
for professional medical advice, diagnosis or treatment. In particular, you should
not rely upon the content contained herein for diagnosing a health problem or disease.
Due to the rapid nature of change in medical science, the information provided on
the Somaxon Websites may not be current. Always seek the advice of your physician
or other qualified health provider with any questions you may have regarding our
products or any medical condition you or your family might have. Never disregard
professional medical advice or delay in seeking it because of something you have
read on the Somaxon Websites.
II. Proprietary Rights and Permitted Use.
Please note that we have invested a significant amount of time, effort, and resources
in the creation of the Somaxon Websites, which are protected by U.S. and international
copyright and intellectual property laws. You understand and agree that Somaxon
retains all right, title, or interest in (including all copyrights, service marks,
trademarks, trade secrets and other intellectual property rights) all content, as
applicable, including without limitation, any and all text, data, graphics, images,
sound, products and other information provided on the Somaxon Websites, whether
by Somaxon or users and whether in print, machine-readable, visual or audible form
(altogether, "Somaxon Content"). You may view, download, print and retain a copy
of the Somaxon Content displayed on the Somaxon Websites only for your own personal
use. The Somaxon Content may not be distributed, downloaded, uploaded, modified,
reused, reproduced, reposted, retransmitted, disseminated, sold, published or circulated
or otherwise used in any way whatsoever except as permitted by the foregoing license.
All trademarks, product names, whether or not appearing in large print or with the
trademark symbol, are trademarks of Somaxon, its affiliates, related companies or
its licensors or joint venture partners unless otherwise noted. The use or misuse
of any of these trademarks or other materials, except as permitted herein, is expressly
prohibited and may be in violation of copyright law, trademark law, the law of slander
and libel, the law of privacy and publicity, and communications regulations and
statues. No license or right is intended to be conveyed to you under any trademark
of Somaxon or any third party, whether by implication, estoppel or otherwise. You
may not use any Somaxon trademark without our prior written consent. Further, you
agree not to remove, alter or obscure any such notices on any printouts, screen
displays or copies thereof. You agree not to add any logos or other marks indicating
origin or ownership or any data or content originally found thereon to any of the
foregoing displays, printouts or copies thereof. If you wish to obtain permission
to reprint or reproduce any materials appearing on the Somaxon Websites other than
as permitted above, you may contact us at email@example.com
. All rights not expressly granted herein are reserved.
III. Forward Looking Statements.
The Somaxon Websites may contain forward-looking statements that are subject to risks
and uncertainties that may cause actual results to differ from those foreseen. 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 vary materially
from those set forth within the Somaxon Websites due to the risks and uncertainties
inherent in Somaxon's business including, without limitation, statements about:
the progress and timing of our clinical trials or regulatory approvals for our product
candidates; difficulties or delays in development, testing, obtaining regulatory
approval, producing and marketing our products; our ability to enter into strategic
transactions or collaborations or other third party agreements; unexpected adverse
side effects or inadequate therapeutic efficacy of our products 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 our
products; the commercial success of Somaxon products; the impact of any competitor
products; our ability to obtain additional financing to support our operations;
and any other risks specified in our press releases of filings with the SEC from
time to time. All forward-looking statements are qualified in their entirety by
this cautionary statement and Somaxon undertakes no obligation to revise or update
the Somaxon Websites site to reflect events or circumstances.
Somaxon will treat any suggestions, questions, comments, data, materials or the like
other than personally identifiable information (collectively, the "Feedback") sent
to Somaxon as non-confidential and non-proprietary information. Somaxon shall have
no obligation of any kind to you or a third party with respect to such Feedback.
You agree that Somaxon shall be free to reproduce, use, disclose, exhibit, display,
transform, create derivative works and distribute such Feedback to others without
limitation and without payment of any consideration to you or a third party. You
further agree that Somaxon shall be free to use and exploit in any manner any ideas,
concepts, know-how or techniques contained in such Feedback for any purpose without
your or a third party's consent, including but not limited to developing, manufacturing
and marketing products and services. Notwithstanding the foregoing, any personal
The Somaxon Websites are being provided by Somaxon to you as a free service. You
agree that you shall be solely responsible for any and all liabilities arising from:
Websites, (iii) your use of or reliance on any Somaxon Content, including any medical
information provided on the Somaxon Websites and/or (iv) any authorized disclosure
(including, without limitation, your authorization that Somaxon disclose your personal
information and credentials to our human resources department). You agree to hold
Somaxon and Somaxon's directors, officers, employees, agents, attorneys, subsidiaries,
affiliates and sublicensees and each of their respective successors and assigns
harmless from all damages, costs, expenses, injuries and other liabilities including,
but not limited to, attorneys' fees and expenses relating to any claim arising out
or resulting from your access to the Somaxon Websites and the Somaxon Content or
your use, disclosure or authorization for Somaxon to disclose any data or content
VI. NO WARRANTY.
YOU ACKNOWLEDGE THAT THE SOMAXON WEBSITES AND THE SOMAXON CONTENT ARE PROVIDED “AS
IS,” “AS-AVAILABLE” AND “WITH ALL FAULTS.” SOMAXON,
ITS EMPLOYEES, SUBSIDIARIES AND AFFILIATES MAKE NO WARRANTY AS TO THE SOMAXON WEBSITES
AND THE ENTIRE RISK IS WITH YOU. TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE
LAW, SOMAXON, ITS DIRECTORS, OFFICERS, EMPLOYEES, SUBSIDIARIES AND AFFILIATES DISCLAIM
ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES
OF NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. SOMAXON
DOES NOT WARRANT THAT THE SOMAXON WEBSITE WILL BE UNINTERRUPTED, SECURE, OR ERROR-FREE,
THAT DEFECTS WILL BE CORRECTED, OR THAT THE SOMAXON WEBSITE OR THE SERVER THAT MAKES
EACH AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. YOU ASSUME ALL RESPONSIBILITY
FOR PROTECTING YOURSELF BY USING ANTI-VIRUS PROGRAMS AND FIREWALLS. INFORMATION
CONTAINED ON THE SOMAXON WEBSITE MAY BE INCOMPLETE, OUTDATED, INACCURATE OR CONTAIN
TYPOGRAPHICAL ERRORS. SOMAXON DOES NOT WARRANT OR MAKE ANY REPRESENTATION REGARDING
THE USE OF THE MATERIAL ON THE SOMAXON WEBSITES IN TERMS OF CORRECTNESS, ACCURACY,
RELIABILITY, OR CURRENCY.
VII. EXCLUSION OF DAMAGES; LIMITATIONS ON LIABILITY.
YOUR USE OF THE SOMAXON WEBSITES IS AT YOUR OWN RISK. IN NO EVENT SHALL SOMAXON OR
ANY OF ITS DIRECTORS, OFFICERS, EMPLOYEES, SUBSIDIARIES OR AFFILIATES BE LIABLE
FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, CONSEQUENTIAL OR EXEMPLARY
DAMAGES (INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF BUSINESS, LOST PROFITS,
LITIGATION, LOSS OF DATA, LOSS OF SERVICES, PERSONAL INJURY (INCLUDING DEATH) OR
DAMAGES TO YOU OR YOUR HARDWARE OR SOFTWARE, EVEN IF SOMAXON HAS BEEN ADVISED OF
THE POSSIBILITY OF SUCH DAMAGES) ARISING OUT OF OR IN CONNECTION WITH YOUR USE OF
THE SOMAXON WEBSITES OR YOUR RELIANCE ON THE SOMAXON CONTENT, WHETHER BASED ON CONTRACT,
NEGLIGENCE, TORT, STRICT LIABILITY OR ANY OTHER THEORY OF LEGAL LIABILITY. BECAUSE
SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL
OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU. ANY CLAIMS ARISING
IN CONNECTION WITH YOUR USE OF THE SOMAXON WEBSITES OR ANY SOMAXON CONTENT (INCLUDING,
WITHOUT LIMITATION, ANY PRODUCT) MUST BE BROUGHT WITHIN ONE (1) YEAR OF THE DATE
OF THE EVENT GIVING RISE TO SUCH ACTION OCCURRED.
Somaxon Websites may contain links to other sites on the Internet that are owned
and operated by third party vendors and other third parties. Clicking on such a
link to a third party site will cause you to leave our Website. The linked third
party sites are not controlled by Somaxon and we are not responsible for the contents
of any linked third party site, any link contained in a linked third party site,
or any changes or updates to such third party sites. We cannot guarantee, represent
or warrant that the content of these sites is accurate, legal, inoffensive, or free
from viruses or other features that may adversely affect your computer. Somaxon
is not responsible for webcasting or any other form of transmission received from
any third party linked site. These links are provided to you only as a convenience
and the inclusion of any third party link does not imply endorsement by us of the
third party site. By using our Websites to link to another site, you agree and understand
that you may not make any claim against us for any damages or losses resulting from
your use of our Website to link to another site.
IX. General Provisions.
invalid, void or unenforceable, the remaining provisions shall nevertheless continue
in full force and effect.
c. Assignment. You may not assign or otherwise transfer in any way any of the rights
of Somaxon, which may be withheld at its sole and absolute discretion. Somaxon may
California as such laws are applied to contracts executed in and to be performed
entirely within California by California residents. This means that California law
e. Arbitration. Any controversy, dispute or claim of any nature whatsoever, arising
any party hereto, including any claim based on contract, tort or statute that may
lawfully be arbitrated, and including the issue of arbitrability of any such disputes,
will be resolved by final and binding arbitration before a retired judge or justice
in San Diego, California. Any interim or final relief or award granted by the Arbitrator,
including without limitation any provisional relief, may be enforced, and final
judgment upon any award or decision rendered by the Arbitrator may be entered and
enforced, by any state or federal court having jurisdiction.
f. Void Where Prohibited. Although the Somaxon Content on the Somaxon Websites is
accessible to users outside of the United States, the Somaxon Content herein is
intended for use only by residents of the United States. Other countries and jurisdictions
may have laws, regulatory requirements and medical practices that differ from those
in the United States . Somaxon may have links to other sites some of which are outside
the United States. Those websites may have information that is appropriate only
to that particular originating country.
the entire agreement between you and Somaxon with respect to the subject matter
hereof and supersede all prior agreements, understandings, negotiations and discussions,
whether oral or written. Unless otherwise required by law, Somaxon may amend these
a continuing waiver unless otherwise expressly provided.
If you have any questions about the foregoing, please contact Somaxon at the following
e-mail address: firstname.lastname@example.org or mail us
Somaxon Pharmaceuticals, Inc.
3830 Valley Centre Drive, Suite 705-461
San Diego, CA, 92130
Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
IMPORTANT SAFETY INFORMATION
Silenor is contraindicated in individuals who have shown hypersensitivity to doxepin
HCl, any of its inactive ingredients, or other dibenzoxepines. Serious side effects
and even death have been reported following the concomitant use of certain drugs
with MAO inhibitors (MAOIs). Do not administer Silenor if patient is currently on
MAOIs or has used MAOIs within the past two weeks. The exact length of time may
vary depending on the particular MAOI dosage and duration of treatment.
Silenor is contraindicated in individuals with untreated narrow angle glaucoma or
severe urinary retention.
The failure of insomnia to remit after 7 to 10 days of treatment may indicate the
presence of a primary psychiatric and/or medical illness that should be evaluated.
Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after
ingestion of a hypnotic, with amnesia for the event) have been reported with hypnotics.
These events can occur in hypnotic-naive as well as in hypnotic-experienced persons.
Although behaviors such as "sleep-driving" may occur with hypnotics alone at therapeutic
doses, the use of alcohol or other central nervous system depressants with hypnotics
appears to increase the risk of such behaviors, as does the use of hypnotics at
doses exceeding the maximum recommended dose. Due to the risk to the patient and
the community, discontinuation of Silenor should be strongly considered for patients
who report a "sleep-driving" episode. Other complex behaviors (i.e., preparing and
eating food, making phone calls, or having sex) have been reported in patients who
are not fully awake after taking a hypnotic. As with "sleep-driving", patients usually
do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms
may occur unpredictably.
Patients should not consume alcohol with Silenor. Patients should be cautioned about
potential additive effects of Silenor used in combination with CNS depressants or
In primarily depressed patients, worsening of depression, including suicidal thoughts
and actions (including completed suicides), has been reported in association with
the use of hypnotics. Doxepin, the active ingredient in Silenor, is an antidepressant
at doses 10- to 100-fold higher than in Silenor. Antidepressants increased the risk
compared to placebo of suicidal thinking and behavior in children, adolescents,
and young adults in short-term studies of major depressive disorder (MDD) and other
psychiatric disorders. Risk from the lower dose of doxepin in Silenor can not be
Patients should not take Silenor unless they are prepared to get a full night’s
sleep. After taking Silenor, patients should confine their activities to those necessary
to prepare for bed. Patients should avoid engaging in hazardous activities, such
as operating a motor vehicle or heavy machinery, at night after taking Silenor,
and should be cautioned about potential impairment in the performance of such activities
that may occur the day following ingestion.
For faster onset and to minimize the potential for next day effects, Silenor should
not be taken within 3 hours of a meal.
In clinical trials, the most common treatment-emergent adverse reaction was somnolence/sedation.
Silenor has not been studied in pregnant women. Silenor is excreted in human milk
after oral administration. Silenor is not approved for use in children.
Please see complete Prescribing Information before prescribing