Privacy Policy
Welcome to www.silenor.com, a Somaxon Pharmaceuticals,
Inc. ("Somaxon," "us," "our" or "we") website. Somaxon values your privacy. In order
for you to understand how we may collect, use and/or disclose information about
visitors of our website, located at www.silenor.com
(the "Somaxon Website"), we have prepared this privacy policy (this "Privacy Policy").
Please be sure to read this Privacy Policy before using and submitting information
on any of our websites. Your use of silenor.com and any other Somaxon website is
subject to this Privacy Policy as well as the Terms of Use.
Please refer often to this Privacy Policy as it may change from time to time. Questions
regarding this privacy policy should be directed to: info@somaxon.com.
I. Information We Collect
a. Personal Information.
At this time, we may collect information from visitors like you through your submission
of your email or personal address such as when you create a profile, send us an
e-mail or register for updates. Such information may include your first and last
name, email address and any other content provided by you.
All of this information that we may collect is collectively referred to as "Personal
Information."
b. Non-Personal Information.
Non-Personal Information is information that is not personal, such as questions,
comments, ideas and suggestions that you provide, or information that we may collect
that is not linked to any Personal Information. With the goal of improving our products,
content and services, we may collect and store Non-Personal Information. Non-Personal
Information also includes: (i) the domain and host from which you access the Internet;
(ii) the Internet address of the website from which you linked directly to our website,
if applicable; (iii) the date and time you arrived at our website and how long you
spent on the website and which pages you visited; (iv) your Internet protocol (IP)
address; and (v) your computer's operating system and browser software. Somaxon
does not use this information to determine the individual identity of any website
visitor. Non-Personal Information will be treated as non-confidential, and we may
disclose and/or use that information without any obligation whatsoever to you, for
any purpose and through any means.
II. Use and Disclosure of Your Personal Information
a. General Rule.
Personal Information we collect from you is used solely by Somaxon and is not rented,
sold, or given to third parties except as otherwise provided herein. In general,
this information is used to send you updated information about Somaxon or to address
questions or comments given to us by you. Personal Information may also be used
to help us identify those individuals who have accessed our product support information.
We reserve the right to enhance our use of Personal Information at any time. Any
change in our use of Personal Information will be disclosed within this Privacy
Policy. We may also share your Personal Information with: (i) a parent company,
any subsidiaries, joint ventures, or other companies under common control with Somaxon
now or in the future; (ii) vendors and service providers who assist us in providing
service to you; and (iii) any acquirer or successor of Somaxon based upon a sale,
merger, assignment or transfer of the business of the website to which the information
relates. We will require that any third parties receiving such information be required
to honor this Privacy Policy, or a substantially similar privacy policy, with respect
to such shared information.
b. Enforcement of Law and/or Terms of Use.
From time to time, we may be required by law enforcement or judicial authorities
to provide Personal Information to the appropriate governmental authorities. We
will disclose Personal Information upon receipt of a court order or subpoena or
to cooperate with a law enforcement investigation. We fully cooperate with law enforcement
agencies in identifying those who use our services for illegal or fraudulent activities.
We reserve the right to report to law enforcement agencies any activities that we
in good faith believe to be unlawful. Moreover, we may release account information
and Personal Information when we believe that such release is reasonably necessary
to enforce or apply our Terms of Use, establish or exercise our legal rights or
defend against legal claims or to protect the rights, property and safety of our
users, others and ourselves.
III. Safeguarding Your Personal Information
a. Our Security Measures.
Somaxon has put into place physical, electronic and managerial procedures to help
safeguard and prevent unauthorized access, use and/or disclosure of your Personal
Information. Although Somaxon uses reasonable efforts to safeguard the security
of your Personal Information, transmissions made on or through the Internet are
vulnerable to attack and cannot be guaranteed to be secure. In addition, submissions
made via email are not protected by encryption and are vulnerable to interception
during transmission.
b. Protecting Yourself.
Please be careful and responsible whenever you are online. Our websites may contain
links to third parties who may collect information directly from you. Each of the
websites linked from our websites have separate Privacy Policies and data collection
practices, independent of Somaxon, and Somaxon has no responsibility or liability
for these independent policies or actions and is not responsible for the privacy
practices or the content of such websites, nor does Somaxon make any warranties
or representations about the contents, products or services offered on such websites
or the security of any information you provide to them. You can learn more about
Internet privacy from government websites such as
www.ftc.gov/privacy/.
To the extent we maintain your email address or other
information about you, you may ask us via email at info@somaxon.com
to have such information deleted, updated or corrected.
IV. Your Privacy Choices
Opting In: You may "opt-in" and receive information from Somaxon, such as updates
about our products, simply by entering your email address in the area provided on
the home page as well as various areas on the Somaxon Website.
Opting Out/Unsubscribing: You may remove yourself from our mailing list at any time
by simply emailing us at info@somaxon.com
and putting "unsubscribe" in the subject line.
V. General
a. Changes To Our Policy.
This Privacy Policy is effective with respect to any Personal Information collected
on or after the effective date first set forth above. Somaxon reserves the right
to modify or supplement this Privacy Policy at any time. If we make any changes,
we will update the Somaxon Website and Privacy Policy to include such change and
notice thereof. Please review this Privacy Policy often to review any changes that
may affect your use of the Somaxon Website. Your continued use of the Somaxon Website
once the revised Privacy Policy has been posted on the Somaxon Website affirms your
agreement to such changes.
b. Children.
We want to let you know that our websites are intended for use by adults and young
adults only. It currently is our policy not to collect Personal Information from
any person under 18, and we request that children under the age of 18 not submit
any personal information to us via the Somaxon Website. If we learn that we have
inadvertently gathered Personal Information from children under 18, we shall attempt
to notify such child's parent or guardian and erase such information from our records,
unless the child's parent or guardian consents to our maintaining such information.
If a parent or guardian has reason to believe that a child has provided us with
Personal Information, the parent or guardian should contact us as provided below.
c. Contact Us.
If you have any questions about this Privacy Policy, the practices of the Somaxon
Website, or your dealings with our Somaxon Website, please contact us by sending
a letter to: Somaxon Pharmaceuticals, Inc., 3830 Valley Centre Drive, Suite 705-461,
San Diego, CA, 92130 Attention: Somaxon Website Administrator or by sending an email
to info@somaxon.com. Or, you can visit our
Contact Us section for more information. Please also see
our Terms of Use which apply to your use of the Somaxon
Website.
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
sedating antihistamines.
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
excluded.
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
Silenor.