Indication: Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset.

Privacy policy

Takeda Website Privacy Policy

Thank you for visiting one of the websites (the "Websites") owned by Takeda Pharmaceuticals U.S.A., Inc., its affiliates or subsidiaries (collectively, “Takeda”).

This privacy policy (the “Privacy Policy”) applies to the personal information collected on Takeda Websites. It also applies to Social Security numbers obtained by oral, written or electronic means, as described below in the “Use of Personal Information” section of this Privacy Policy. The term "personal information" as used throughout this Privacy Policy, applies to any information that is used by or on behalf of Takeda to identify an individual.

We have provided this Privacy Policy to describe to you how we collect, use, share and protect the personal information you provide to us at this Website. This Privacy Policy only applies to personal information we collect at our Websites and via the electronic communications technologies that we use. It does not apply to personal information collected through other means, including personal information you provide in e-mail messages you send to us or personal information we may collect from you offline. This Privacy Policy is intended for all visitors of Takeda Websites including consumers, healthcare professionals and Takeda business partners.

At some of our Websites, we may use personal information in a manner not described in this Privacy Policy. In those instances, the different uses of personal information will be disclosed to you at the web page where your personal information is collected, prior to such collection.

From time to time, our internal processes may change, or we may offer new or altered features at our Websites. If appropriate, we will revise this Privacy Policy. We encourage you to return to this area to read the most recent version of our Privacy Policy. If we alter our practices in a manner that will affect the treatment of the personal information you have already provided, we will attempt to provide visitors who have registered on our Websites with notice of our new Privacy Policy via e-mail.

Table of Contents

Personal Information Collected

  • Information You Provide

In general, you may browse the Takeda Websites without providing any personal information. At our Websites, we may provide you with opportunities to sign up to receive information or services from us. As part of this process, we ask you to provide us with personal information about you (such as name, address, telephone number or e-mail address). For example, you may choose to register to receive e-mail updates about a Website, information about a particular health condition, or materials relating to products or services offered by Takeda and its product-related co-promotion partners, and you may provide us with your e-mail address to receive such communications. You may always choose not to provide us with your personal information, and we will disclose to you at the time we collect your personal information whether it is required for you to receive the information or services you have requested.

To better understand and address your interests, and to keep the personal information we have about you accurate, we may correct or add to the personal information you provide to us at our Websites with personal information we receive from you offline or from other sources.

  • Automatically Collected Information -- Cookies and Other Website Information

Like most other commercial websites, we use standard “cookie” and “web beacon” technology and web server logs to collect information about how our Website is used. Web beacons are transparent pixel images that are used in collecting information about Website visitor activities and e-mail response and tracking. For example, if we send you an e-mail message, we (or third parties providing services on our behalf) may collect information through web beacons to determine whether you have opened the e-mail message or clicked on links located within the e-mail message.

Cookies are pieces of data that a website transfers to a visitor's hard drive for record-keeping purposes. Cookies placed on our Websites may be set directly by our servers or by third parties providing technical services to us. To prevent cookies from tracking you as you navigate our Websites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Please note that some portions of our Websites may not work properly if you refuse cookies.

Information gathered through cookies and by our web server logs may include your IP address, your Internet browser (e.g., Netscape), your operating system (e.g., Windows 2000), the domain name of your internet service provider (e.g., AOL) the date and time of your visits, the pages viewed, the time spent at our Website, and the websites visited just before and just after our Website. This information may be associated with your personal information.

Your Choices

You have several choices regarding your use of our Websites. You could decide not to submit any personal information at all. Although certain Websites may ask for permission to use your personal information for certain purposes, you can agree or decline to provide your personal information. If you subscribe for particular communications or services such as e-mail updates, you will be able to unsubscribe at any time by: (i) following any opt-out instructions contained in communications you receive from Takeda, (ii) un-subscribing at specific areas of the Websites where you registered, if available, or (iii) sending a written request to the Takeda contact address, which appears at the end of this Privacy Policy.

As described above, if you wish to prevent cookies from tracking you as you navigate our Websites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Please note, however, that some portions of our Websites may not work properly if you refuse cookies.

Use of Personal Information

Takeda and its service providers will use your personal information to provide information and services to you, including information and services you have requested, or as otherwise disclosed to you in this Privacy Policy or on the web page where you submit your personal information to us. We may also use that information to provide you with materials about products and services offered by Takeda and its product-related co-promotion partners, including new content or services on our Websites. We may provide you with these materials by phone, mail, facsimile or e-mail. We do not share any of your personal information with third parties for their own direct marketing purposes unless we have your consent.

We may use aggregate information collected from visitors of our Websites to help us better understand visitors’ needs and how they use the Websites. Aggregate information about Website visitors that does not contain personal information may be shared with third parties.

  • Policy on Use of Social Security Numbers

Takeda has a policy which provides for the proper use and protection of Social Security numbers obtained in the course of doing business by Takeda. Such policy protects the confidentiality of Social Security numbers, prohibits unlawful disclosure of Social Security numbers, and limits access to Social Security numbers. This policy applies to all methods of collection of Social Security numbers, including Social Security numbers obtained by oral, written and electronic means.

  • E-mail a Friend or Colleague

On some of the Takeda Websites, you can send a link or e-mail message to a friend or colleague. E-mail addresses you may provide for a friend or colleague will be used to send your friend or colleague information on your behalf and will not be collected or used by Takeda or other third parties for any other purpose.

  • Note to Healthcare Professionals and Business Partners

If you have a business or professional relationship with Takeda, we may use your personal information, including personal information we may collect about you from other sources, to develop our business relationship with you and your organization.

Sharing of Personal Information

Takeda may share personal information about you with: (i) various third-party companies or agents working on our behalf to help us engage in the activities described in the “Use of Personal Information” section of this Privacy Policy, including fulfilling business transactions, providing services or information you requested, providing other customer services, sending marketing communications about our products, services and offers, and conducting technological maintenance, and (ii) our parent company, subsidiaries, affiliates and product-related co-promotion partners.

We may also share your personal information with third parties under the following circumstances:

  • if you request or authorize such a disclosure;
  • in connection with the sale, assignment, license or other transfer of our company or our parent company, subsidiaries, affiliates, product-related co-promotion partners or products;
  • to protect our rights, property or safety, or the rights, property or safety of our employees or others;
  • to enforce an agreement we have with you;
  • to comply with the terms of an agreement with a product-related co-promotion partner;
  • to respond to appropriate requests of legitimate government agencies or where required by applicable laws, court orders or government regulations; or
  • where needed for corporate audits or to investigate or respond to a complaint or security threat.

As a company with global operations, Takeda may share your personal information with parties described in this section who are (1) located in other countries, and (2) subject to other applicable laws, rules and regulations relating to your personal information, that do not offer the same protections as the country in which your personal information was collected. In particular, your personal information may be processed in the United States and subject to applicable US laws, rules and regulations. For more information about how Takeda is committed to protecting your personal information, see the “How We Protect Your Personal Information” section of this Privacy Policy.

Note: We do not share any of your personal information with third parties for their own direct marketing purposes unless you explicitly give us permission to do so.

Personal Information of Children

Our Websites are not intended or designed to attract children under the age of 18, and we do not believe that our Websites are appealing to children. Therefore, we do not knowingly collect any personal information from anyone under the age of 18 at our Websites.

Links to Other Websites

Our Websites may provide links to other websites as a service to you. The third-party websites are operated by companies that are outside of our control, and your activities at those websites will be governed by the policies and privacy practices of those third parties. We do not recommend or endorse the content of these websites. We encourage you to review the policies and privacy practices of those third parties before disclosing any of your personal information, as we are not responsible for their policies and privacy practices.

How We Protect Your Personal Information

To help protect the privacy and security of personal information you transmit through the use of our Websites, we have implemented reasonable physical, technical and administrative safeguards to help protect your personal information against unauthorized access, disclosure, alteration or destruction.

Changing Your Preferences; Opt-Out of Receiving Communications

When you provide us with your personal information, you will be given some choices about how we use that personal information. You may change these preferences later. For example, if you sign up for an e-mail newsletter, you may opt out of receiving future e-mail newsletters at any time. Takeda will always provide you with one or more of the following ways to opt out: (i) by following any opt-out instructions contained in communications you receive from Takeda, (ii) by un-subscribing at specific areas of the Website(s) where you registered, if available, or (iii) by sending a written request to the Takeda contact address immediately below.

Questions; Updating Your Personal Information; Takeda Contact Address

If you have any questions about our privacy practices or if you need help accessing your personal information or changing your preferences, please send a written request to us at the following address:

Takeda Pharmaceuticals U.S.A., Inc.
Attn: Privacy Office/Legal Department – Website Communications
One Takeda Parkway
Deerfield, Illinois 60015

Note: Please make sure to provide the name of the Website(s) applicable to your request, and your name, address, telephone number and e-mail address (if any). If you do not provide us with this information, we may not be able to respond.

  • Note to Employment-Applicant Users of Our Websites

If you wish to modify or update your personal information submitted at one of our Websites in response to an employment opportunity at Takeda, you can do so on the appropriate web page of the Website where you applied.

Effective Date of Privacy Policy

This Privacy Policy is effective as of January 1, 2013.

Important Safety Information for Rozerem (ramelteon)

  • In rare cases, severe anaphylactic and anaphylactoid reactions have occurred following use of Rozerem. Angioedema involving the tongue, glottis, or larynx has been reported. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Reactions may require emergency treatment and may be fatal. Patients who develop such reactions should not be rechallenged.
  • Rozerem should not be used in patients with severe hepatic impairment or in combination with Luvox® (fluvoxamine).
  • Failure of insomnia to remit after 7–10 days, worsening of insomnia, or emergence of new cognitive or behavioral abnormalities should be medically evaluated, as this may be the result of an unrecognized underlying medical/psychiatric disorder.
  • In primarily depressed patients, worsening of depression, including suicidal ideation and completed suicides, can occur with hypnotics.
  • Hallucinations, as well as behavioral changes such as bizarre behavior, agitation, and mania, have been reported with Rozerem use. Amnesia, anxiety, and other neuropsychiatric symptoms may also occur unpredictably.
  • Complex behaviors such as “sleep-driving," making or eating food, talking on the phone, sleep-walking, or engaging in other activities while not fully awake, with amnesia for the event, may occur with use of hypnotics, including Rozerem. The use of alcohol with Rozerem may increase the risk of such behaviors. Discontinuation of Rozerem should be strongly considered for patients who report any complex sleep behavior.
  • Patients should avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem.
  • Rozerem should be taken within 30 minutes before going to bed and activities confined to preparing for bed.
  • Patients should be advised not to consume alcohol in combination with Rozerem, as alcohol and Rozerem may have additive effects when used in conjunction.
  • Rozerem has been associated with decreased testosterone levels and increased prolactin levels. Patients may experience cessation of menses or galactorrhea in females, decreased libido, or fertility problems that are possibly associated with such hormone changes.
  • Rozerem has not been studied in patients with severe sleep apnea and is not recommended for use in this population.
  • Safety and effectiveness of Rozerem in pediatric patients have not been established.
  • Rozerem should not be taken with or immediately after a high-fat meal.
  • The most common adverse reactions (≥3% and more common than with placebo) are somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.

Indication

Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset.


Please see Full Prescribing Information and Medication Guide for Rozerem.

Show references

  1. Mayer G, Wang-Weigand S, Roth-Schechter B, Lehmann R, Staner C, Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic, primary insomnia. Sleep. 2009;32:351-360.
  2. Rozerem package insert, Takeda Pharmaceuticals America, Inc.
  3. Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006;63:1149-1157.
  4. Data on file, Takeda Pharmaceuticals U.S.A., Inc.
  5. Dubocovich ML, Rivera-Bermúdez MA, Gerdin MJ, Masana MI. Molecular pharmacology, regulation and function of mammalian melatonin receptors. Front Biosci. 2003;8:d1093-d1108.
  6. Kato K, Hirai K, Nishiyama K, et al. Neurochemical properties of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology. 2005;48:301-310.
  7. Ekmekcioglu C. Melatonin receptors in humans: biological role and clinical relevance. Biomed Pharmacother. 2006;60:97-108.
  8. Dubocovich ML, Benloucif S, Masana MI. Melatonin receptors in the mammalian suprachiasmatic nucleus. Behav Brain Res. 1996;73:141-147.
  9. Liu C, Weaver DR, Jin X, et al. Molecular dissection of two distinct actions of melatonin on the suprachiasmatic circadian clock. Neuron. 1997;19:91-102.
  10. Lavie P. Sleep-wake as a biological rhythm. Annu Rev Psychol. 2001;52:277-303.
  11. The American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63:2227-2246.
  12. Roth T, Seiden D, Sainati S, et. Al. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006;7:312-318.
  13. US Dept of Justice. Controlled Substances. Drug Enforcement Administration website. Available at:
    http://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf. Accessed on September 22, 2016.
  14. Kryger M, Wang-Weigand S, Zhang J, Roth T. Effect of ramelteon, a selective MT(1)/MT(2)-receptor agonist, on respiration during sleep in mild to moderate COPD. Sleep Breath. 2008;12:243-250.
  15. Hummel M, Unterwald EM. D1 dopamine receptor: a putative neurochemical and behavioral link to cocaine action. J Cell Physiol. 2002;191:17-27.
  16. Malcolm RJ. GABA systems, benzodiazepines, and substance dependence. J Clin Psychiatry. 2003;64(suppl 3):36-40.
  17. Nestler EJ. Historical review: molecular and cellular mechanisms of opiate and cocaine addiction. Trends Pharmacol Sci. 2004;25:210-218.
  18. Rudolph U, Crestani F, Benke D, et al. Benzodiazepine actions mediated by specific g-aminobutyric acidA receptor subtypes. Nature. 1999;401:796-800.
  19. Rowlett JK, Platt DM, Lelas S, Atack JR, Dawson GR. Different GABAA receptor subtypes mediate the anxiolytic, abuse-related, and motor effects of benzodiazepine-like drugs in primates. Proc Natl Acad Sci U S A. 2005;102(suppl 3):915-920.
  20. Landolt HP, Gillin JC. GABAA1a receptors: involvement in sleep regulation and potential of selective agonists in the treatment of insomnia. CNS Drugs. 2000;13:185-199.
  21. Kryger M, Roth T, Wang-Weigand S, Zhang J. The effects of ramelteon on respiration during sleep in subjects with moderate to severe chronic obstructive pulmonary disease. Sleep Breath. 2009;13:79-84.

Important Safety Information for Rozerem (ramelteon)

Important Safety Information for Rozerem (ramelteon)

  • In rare cases, severe anaphylactic and anaphylactoid reactions have occurred following use of Rozerem. Angioedema involving the tongue, glottis, or larynx has been reported. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Reactions may require emergency treatment and may be fatal. Patients who develop such reactions should not be rechallenged.
  • Rozerem should not be used in patients with severe hepatic impairment or in combination with Luvox® (fluvoxamine).
  • Failure of insomnia to remit after 7–10 days, worsening of insomnia, or emergence of new cognitive or behavioral abnormalities should be medically evaluated, as this may be the result of an unrecognized underlying medical/psychiatric disorder.
  • In primarily depressed patients, worsening of depression, including suicidal ideation and completed suicides, can occur with hypnotics.
  • Hallucinations, as well as behavioral changes such as bizarre behavior, agitation, and mania, have been reported with Rozerem use. Amnesia, anxiety, and other neuropsychiatric symptoms may also occur unpredictably.
  • Complex behaviors such as “sleep-driving," making or eating food, talking on the phone, sleep-walking, or engaging in other activities while not fully awake, with amnesia for the event, may occur with use of hypnotics, including Rozerem. The use of alcohol with Rozerem may increase the risk of such behaviors. Discontinuation of Rozerem should be strongly considered for patients who report any complex sleep behavior.
  • Patients should avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem.
  • Rozerem should be taken within 30 minutes before going to bed and activities confined to preparing for bed.
  • Patients should be advised not to consume alcohol in combination with Rozerem, as alcohol and Rozerem may have additive effects when used in conjunction.
  • Rozerem has been associated with decreased testosterone levels and increased prolactin levels. Patients may experience cessation of menses or galactorrhea in females, decreased libido, or fertility problems that are possibly associated with such hormone changes.
  • Rozerem has not been studied in patients with severe sleep apnea and is not recommended for use in this population.
  • Safety and effectiveness of Rozerem in pediatric patients have not been established.
  • Rozerem should not be taken with or immediately after a high-fat meal.
  • The most common adverse reactions (≥3% and more common than with placebo) are somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.

Indication

Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset.


Please see Full Prescribing Information and Medication Guide for Rozerem.