You generally are not required to provide information about yourself when you visit the Services. However, we may ask you for some or all of the following types of information when you request additional information about Non-24-Hour Sleep-Wake Disorder (Non-24) and HETLIOZ® (tasimelteon); request tools, resources, and information about events for the blindness community; share a personal experience with Non-24 and HETLIOZ®; access various content or features; submit content; or directly contact us with questions or feedback.
We also may collect certain information automatically when you visit the Services, including:
Vanda may use information that we collect through the Services to provide you with products, promotions, services, newsletters, and information in accordance with your preferences, and to respond to correspondence that we receive from you. Sometimes, we may use the information that we collect to contact you via e-mail, telephone, or otherwise about medicines that treat Non-24, Vanda, and our products and services; to learn more about your experience with Non-24; or to otherwise provide you with information that might be of interest to you. At your election at any time, you may choose to stop receiving future communications from Vanda ("opt-out;" see below for more information on how to opt-out).
We also may use information that we collect to maintain or administer the Services, perform business analyses, or for other internal purposes to improve the quality of our business, the Services, and other products and services we offer. For example, Vanda uses information collected automatically to help diagnose problems with its server, analyze trends, and administer the Services. We also may use information that you provide to customize and personalize your use of the Services and as otherwise described to you at the point of collection or pursuant to your consent.
We are committed to maintaining your trust, and we want you to understand when and with whom we may share the information we collect.
We take a number of steps to help protect against loss, misuse, unauthorized access, disclosure, alteration or destruction of the information you provide to us. Unfortunately, no data transmission over the Internet can be guaranteed to be 100% secure. As a result, Vanda cannot ensure the security of any information you provide, and you do so at your own risk.
The Services do not knowingly collect, use, or disclose personal information from children under the age of 13 without prior parental consent, except as permitted by the Children's Online Privacy Protection Act ("COPPA").
We may allow third parties to place and read their own cookies, pixel tags, web beacons, Local Shared Objects, and similar technologies to collect information through the Services. For example, our third-party service providers may use these technologies to collect information that helps us with traffic measurement, research, analytics, and providing you with relevant advertisements.
Vanda has worked with certain third-party social media providers to offer you their social networking services through our Services. For example, you can use third-party social networking services, including but not limited to Facebook, Twitter, and others to share information about your experience on our Services with your friends and followers on those social networking services. These social networking services may be able to collect information about you, including your activity on our Services. These third-party social networking services also may notify your friends, both on our Services and on the social networking services themselves, that you are a user of our Services or about your use of our Services, in accordance with applicable law and their own privacy policies. If you choose to access or make use of third-party social networking services, we may receive information about you that you have made available to those social networking services, including information about your contacts on those social networking services.
You may elect to avoid future e-mail communications from Vanda by sending an e-mail to firstname.lastname@example.org with your electronic mail address.
Some web browsers may transmit "do-not-track" signals to the websites with which the user communicates. Because of differences in how web browsers incorporate and activate this feature, it is not always clear whether users intend for these signals to be transmitted, or whether they even are aware of them. Because there currently is no industry standard concerning what, if anything, websites should do when they receive such signals, we currently do not take action in response to these signals. If and when a final standard is established and accepted, we will reassess how to respond to these signals. In some cases, third parties may be able to collect information about a user's online activities over time and across different websites when he or she uses our Services.
Vanda does not share information that it collects with third parties for the third party's direct marketing purposes.
HETLIOZ® (HeT-lee-ōz) [tasimelteon] capsules are indicated for the treatment of:
HETLIOZ LQ™ (HeT-lee-oz el-Cue) oral suspension is indicated for:
Important Safety Information
HETLIOZ® may cause drowsiness. After taking HETLIOZ®, limit your activity to preparing for bed. HETLIOZ® can potentially impair your ability to perform activities that require complete mental alertness.
The most common side effects associated with HETLIOZ® include headache, elevated liver enzymes (ALT), nightmares or abnormal dreams, and upper respiratory or urinary tract infection. These side effects may occur more frequently in patients 65 years of age or older. Adverse reactions were similar in patients treated for (Non-24) and patients with SMS treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQ™ oral suspension, and patients ≥16 years of age who received HETLIOZ® capsules.
Tell your healthcare provider about all of the medicines you're taking. HETLIOZ® should not be taken in combination with fluvoxamine or rifampin.
Tell your healthcare provider about all of your health conditions, including whether you are pregnant, are planning to become pregnant, or are breastfeeding. HETLIOZ® has not been studied in pregnant women.
The safety and effectiveness of HETLIOZ® for the treatment of Non-24-Hour in children have not been established. The safety and effectiveness of HETLIOZ LQ™ oral suspension for the treatment of nighttime sleep disturbances in SMS have been established in pediatric patients 3 years and older.
HETLIOZ® is not recommended for use in patients with severe liver problems.
Consumer Important Safety Information
You are encouraged to report side effects of prescription drugs to the FDA. To report side effects, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-0178 or www.fda.gov/medwatch.
For more information, ask your healthcare provider or call 1-844-HETLIOZ (1-844-438-5469).
This information does not take the place of talking with your healthcare provider for medical advice about your condition or treatment.
Download an accessible PDF or listen to the full US Prescribing Information. You can also hear the full US Prescribing Information by calling 1-844-HETLIOZ (1-844-438-5469).