Terms and Conditions
- COPYRIGHT AND TRADEMARK NOTICE
- RESTRICTIONS ON USING THE CONTENT OF THIS WEBSITE
Purdue makes no representation regarding the availability, the accuracy, or the completeness of the content of this Site. The Site contains information about products that may or may not be available in a particular country or region of the world, may be available under different trademarks in different countries and, where applicable, may be approved by government regulatory authority for sale or use with different indications and restrictions in different countries.
This Site may contain, from time to time, information related to various health, medical and fitness conditions and their treatment. For non-healthcare providers, such information is not intended to be a substitute for the advice provided by a physician or other medical professional. You should not use the information contained herein for diagnosing a health or fitness problem or disease. In any event, users of this Site should always consult a doctor and/or other medical professional with respect to health concerns.
While Purdue uses reasonable efforts to include accurate and up-to-date information in its Site, Purdue makes no warranties or representations as to its accuracy. Purdue assumes no liability or responsibility for any errors or omissions in the content of its Site. This Site may provide links or references to other Web sites not affiliated with Purdue. Such links to other Sites are provided only as a convenience to users of this Site. Purdue has not reviewed all of the Sites that may be linked to its Site, and is not responsible for the content of any other Site linked to this Site. Linking to any pages off this Site is at your own risk. Purdue shall not be liable for any damages or injury arising from users’ access to such Sites.
- INDEMNIFICATION BY SITE USER
- LIMITATION OF LIABILITY
Purdue provides the contents of its Site for informational purposes and for your general interest and entertainment only. By using the Site you hereby agree not to rely on any of the information contained herein. UNDER NO CIRCUMSTANCES SHALL PURDUE BE LIABLE FOR YOUR RELIANCE ON ANY SUCH INFORMATION NOR SHALL PURDUE BE LIABLE FOR DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, ANY DIRECT, INCIDENTAL, SPECIAL CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES THAT RESULT FROM THE USE OF, OR THE INABILITY TO USE, THE MATERIALS IN THIS SITE OR THE MATERIALS IN ANY SITE WHICH MAY BE LINKED TO THIS SITE, EVEN IF PURDUE OR A PURDUE AUTHORIZED REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. APPLICABLE LAW MAY NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY OR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. IN NO EVENT SHALL PURDUE’S TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION WHETHER THE CAUSE OF ACTION IS IN CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE) OR OTHERWISE EXCEED THE AMOUNT PAID BY YOU, IF ANY, FOR ACCESSING THIS SITE.
- DISCLAIMER OF WARRANTIES
THE MATERIALS IN THIS SITE ARE PROVIDED "AS IS" AND WITHOUT WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, PURDUE DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. PURDUE DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE MATERIALS WILL BE UNINTERRUPTED OR ERROR-FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT THIS SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. PURDUE DOES NOT WARRANT OR MAKE ANY REPRESENTATIONS REGARDING THE USE OR THE RESULTS OF THE USE OF THE MATERIALS IN THESE SITES IN TERMS OF THEIR CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE. YOU (AND NOT PURDUE) ASSUME THE ENTIRE COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION. APPLICABLE LAW MAY NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.
- JURISDICTIONAL ISSUES/EXPORT RESTRICTIONS
This Site may link to other Sites produced by companies related to Purdue, some of which are outside the U.S. Those Sites may have information that is appropriate only to the particular originating country or region where the Site is based. You should not construe anything on the Site as a promotion or solicitation for any product or for the use of any product that is not authorized by the laws and regulations of the country where you are located. Purdue makes no representation that materials in the Site are appropriate or available for use in other locations. Those who choose to access this Site from other locations do so on their own initiative and are responsible for compliance with local laws, if and to the extent local laws are applicable.
Software from this Site is further subject to United States export controls. No software from this Site may be downloaded or otherwise exported or re-exported (i) into (or to a national or resident of) Cuba, Iraq, Libya, North Korea, Iran, Syria or any other country subject to United States export control restrictions; or (ii) to anyone on the U.S. Treasury Department’s list of Specially Designated Nationals or the U.S. Commerce Department’s Table of Denial Orders. By downloading or using the Software, you represent and warrant that you are not located in, under the control of, or a national or resident of any such country or on any such list.
- CAREER AND/OR BUSINESS OPPORTUNITIES
The Site displays information about job postings ("Current Openings") for informational purposes only. This information is subject to change without notice, and in displaying such information Purdue makes no representation or warranty that the information contained on the Site will be timely or free of errors and omissions.
It is the intent of Purdue to leave you with absolute control over the decision to forward your personal information or resume to the company. It is your choice to give Purdue your personal information via the Internet, Fax or Mail.
Although accessible by others, the intent of Purdue in displaying Current Openings on this Site is to display employment opportunities within the United States of America. You should not construe anything on the Site as a promotion or solicitation for employment not authorized by the laws and regulations of the country where you are located.
- LINKING POLICY
Links Out — This Site may provide links or references to other Web sites not affiliated with Purdue. Purdue has not reviewed the content of Web sites that may be linked to its Site, makes no representations about the content of the Web sites, and is not responsible for the content of any other Web site linked to this Site. Linking to any pages off this Site is at your own risk. Purdue shall not be liable for any damages or injury arising from users' access to such Web sites.
Links In — Unless otherwise set forth in a written agreement between you and Purdue, you must adhere to Purdue's linking policy as follows: i) any link to a Purdue Site must be a text only link clearly marked with the name of the specific Purdue Web site, ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Purdue's name or trademarks, iii) the link must point to one of the specific Purdue Web site URL's homepage and not to other pages within the Web site, iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, associated with, or affiliated with Purdue or the Site, v) when selected by the user, the link must display the Web site on full screen and not within a "frame" on the linking Website, and vi) the linked Web site must comply with all applicable U.S. laws, rules, and regulations. Purdue shall not be liable for any damages or injury arising from such Links In any Purdue Site.
- PERSONAL INFORMATION WE COLLECT
Information we collect from visitors
Visitors to Purdue Sites can access the Site's home page, and browse some areas of the site, without disclosing any personally identifiable information. We do track information provided to us by your browser, including the Site you came from (known as the referring URL), the type of browser you use, the time and date of access, and other information that does not personally identify you. On some of our sites, you must register to access portions of the site.
In addition, we gather information about you that is automatically collected by our Web server, such as your IP address and domain name. Purdue may use Web server and browser information to individually customize its offerings and presentations if you submit your personal information.
Information we collect when you register
Visitors registering for services on our Web sites are asked to provide identifying information, such as name, gender, and contact information. On the registration screen, we label which information is required for registration, and which information is optional and may be given at your discretion. Purdue Sites obtain visitors' consent before collecting personally identifiable information.
Information from outside sources
We may also collect information about physicians or other health care professionals who register on Purdue Sites from other sources in order to verify their licensure status and identity. In some cases, we ask customers for information after they register, such as credit card information. Where necessary (for example, to process an order for a purchase), our Web sites may contact financial or credit organizations to confirm customer credit card information.
From time to time we may augment our existing user databases with legally obtained information from third parties. Some of this information may be personally identifiable, such as national change of address information. We do this to better target our information offerings and promotional campaigns and to provide pertinent offers in which we think you would be interested.
We may also collect information that you voluntarily provide to us through responses to surveys, search functions, questionnaires, feedback, forms and the like.
- On some of our Sites, we offer health assessment tools that ask you to provide self-assessment information.
- We may also ask you to provide additional information such as your e-mail address if you want to obtain additional services or information or to resolve complaints or concerns.
- Purdue will take reasonable steps to safeguard any information you share with us. Purdue stores the information you provide about yourself in a database in order to provide you with the information you request. The information is stored for the lifetime of the database unless you request that it be removed.
- Purdue will limit the collection and use of your information that Purdue requires to deliver superior service to you, which includes advising you about Purdue's products, newsletters, services and other opportunities, and to administer Purdue's business.
- This Site is not intended or designed to attract children under the age of 13. We do not knowingly collect personally identifiable data from site visitors under the age of 13.
- Except as described above, Purdue will not otherwise use or disclose any of your personally identifiable information, except to the extent reasonably necessary: (i) to correct technical problems and malfunctions, to technically process your information and to determine the effectiveness of our projects; (ii) to protect the security and integrity of our website; (iii) to protect our rights and property and the rights and property of others; (iv) to take precautions against liability; (v) to the extent required by law or to respond to judicial process; or (vi) to the enforcement agencies or for an investigation on a matter related to public safety, as applicable.
- As a resource to Site visitors, Purdue may provide links to other websites. Site users should carefully review the privacy policies and practices of these websites, as Purdue cannot control or be responsible for the privacy practices of other Web sites.
- At any time, you can contact Purdue to remove your name from our marketing list.
- THIRD PARTIES. Purdue may share some kinds of information with third parties as described below:
Companies and people who work for us: Purdue contracts with other companies and individuals to help Purdue provide services. For example, Purdue may host some of our Sites on another company's computers, hire technical consultants to maintain our Web-based health sites, or work with companies to remove repetitive information from customer lists, analyze data, provide marketing assistance, and provide customer service. In addition, if you are a health care professional, Purdue may validate your licensure status and other information against available databases that list licensed health care professionals. In order to perform their jobs, these other companies may have limited access to some of the personal information Purdue maintains about our users. Other companies may collect information on our behalf through their sites. This occasionally incorporates the use of frames on the site that will not show the URL you are visiting in the browser address window. We require such companies to comply with the terms of our privacy policies, to limit their access to any personal information to the minimum necessary to perform their obligations, and not to use the information they may access for purposes other than fulfilling their responsibilities to us. We use our best efforts to limit other companies’ use of personally identifiable or health care information.
- Promotional and informational offers: Sometimes Purdue sends offers to selected groups of customers. To accomplish this Purdue may use third parties working on behalf of Purdue. Purdue provides a variety of mechanisms for you to tell us you do not want to receive such promotional - informational offers. For example, Purdue may provide an opt-in box for customers to receive information that is sent by a third-party fulfillment house. You can elect not to receive promotional or informational material from us by following the instructions to opt-out as mentioned or included in each of our programs that Purdue sends to you.
- Legal requirements: We may release account and other personal information when Purdue believes that its release is required to comply with the law, regulations, rules or local ordinances. We may release personal health information if, in our judgment after review by an attorney, the release is compelled by law or regulation, or if the release may be necessary to prevent the death or serious injury of an individual.
Social Security Number Protection Policy
Purdue is committed to the responsible protection of your Social Security number ("SSN"). This notice applies to any SSN that Purdue collects in the course of our business. Purdue protect the confidentiality of SSNs, including by maintaining manual and/or electronic security procedures to guard against unauthorized access to SSNs. Purdue also limits access to SSNs, including by only granting access to SSNs to Purdue employees who use that information to perform their job-related duties. In addition, Purdue disclose SSNs to third parties only where necessary for business purposes and not otherwise prohibited by law.
Important Safety Information
Intermezzo® (zolpidem tartrate) is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.
Co-administration with Intermezzo and other CNS depressants increases the risk of CNS depression. Intermezzo should not be taken with alcohol. The use of Intermezzo with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.
The risk of next-day driving impairment (and psychomotor impairment) is increased if Intermezzo is taken with less than 4 hours of bedtime remaining; if higher than recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of zolpidem. A small negative effect on SDLP (standard deviation of lateral position, a measure of driving impairment) may remain in some patients 4 hours after taking Intermezzo, such that a potential negative effect on driving cannot be completely excluded.
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.
Cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. Angioedema, and additional symptoms suggesting anaphylaxis, may occur in patients taking zolpidem and may be fatal. Patients who develop angioedema or anaphylaxis should not be rechallenged.
Abnormal thinking and behavior changes have been reported in patients treated with a sedative-hypnotic including zolpidem. Complex behaviors, including driving or eating while not fully awake, with amnesia for the event, as well as visual and auditory hallucinations and abnormal behaviors such as decreased inhibition, bizarre behavior, agitation, and depersonalization may occur. Although behaviors such as “sleep-driving” have occurred with zolpidem alone at therapeutic doses, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviors, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of Intermezzo should be strongly considered for patients reporting a “sleep-driving” episode.
In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported with the use of sedative-hypnotics. Intentional overdosage is more common in this group of patients; therefore, protective measures may be required and prescribe the least amount of Intermezzo that is feasible.
Because persons with a history of addiction to or abuse of drugs or alcohol are at increased risk for misuse, abuse, and addiction of zolpidem, they should be monitored carefully when receiving Intermezzo. Zolpidem tartrate is a Schedule IV controlled substance. Post-marketing reports of abuse, dependence, and withdrawal resulting from use of oral zolpidem tartrate have been received. Zolpidem has produced withdrawal signs and symptoms following a rapid dose decrease or abrupt discontinuation.
The most commonly observed adverse reactions (>1%) were headache (Intermezzo 3%, placebo 1%), nausea (1% for both patient groups), and fatigue (Intermezzo 1%, placebo 0%).
Please read the Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.
Intended for healthcare professionals of the United States of America only. ©2014 Purdue Pharma L.P., Stamford, CT 06901-3431