Terms of Use

The following Terms of Use govern and apply to your access to and use of this website. PLEASE READ AND REVIEW THESE TERMS OF USE CAREFULLY EVERY TIME YOU ACCESS OR USE THE WEBSITE. BY ACCESSING OR USING THE WEBSITE, YOU ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREED TO THESE TERMS OF USE.

1. Access to and Use of this Website.

This website is owned by Jazz Pharmaceuticals, Inc. The information provided on this website is for general information purposes only and is subject to these Terms of Use. These Terms of Use may be revised at any time, new conditions for use of this website may be imposed, or access may be restricted to some parts of this website. Any such revisions or modifications will be effective immediately upon notice to you, which may be given by any means, including posting on this website. If you use this website after such notice, you will be deemed to have accepted the revisions or modifications.

2. Product Information.

Product information on this website is intended for use only by residents of the U.S. This website does not provide instruction on the appropriate use of any product of Jazz Pharmaceuticals plc or its subsidiaries or affiliates (which are referred to together in these Terms of Use as “Jazz Pharmaceuticals”) or Jazz Pharmaceuticals’ licensors. Information on this website regarding any products approved for marketing is qualified in its entirety by reference to the approved prescribing information for each product. The information presented on this website should not be interpreted or construed in any way as providing medical advice or as a replacement or substitute for medical advice provided by your doctor or healthcare provider. It is important for you to discuss your treatment options, and any questions that you may have, with your doctor or healthcare provider. You should not use this website to diagnose or treat a health problem or disease.

3. Accuracy of Information.

Jazz Pharmaceuticals uses reasonable care to include accurate information, news, or other postings at the time they are added to this website. Please note, however, that Jazz Pharmaceuticals cannot guarantee that any information posted on this website is accurate, and it will not be liable for any losses or damage that you may suffer as a result of relying on such information. Certain information on this website may be of an historical nature. All historical information contained in the documents or presentations set out on this website should be understood as referring to events and circumstances as they existed on the date that the relevant documents or presentations were first published or made.

4. Intellectual Property.

The copyright in this website belongs to Jazz Pharmaceuticals. The contents of this website may not be copied other than for non-commercial purposes with all copyright or other proprietary notices retained, and may not be recopied, reproduced or otherwise redistributed. You may not otherwise copy, display, download, distribute, modify, reproduce, republish or retransmit any information, text, documents or other postings contained in this website or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such images, text, documents, or other postings, without the express written consent of Jazz Pharmaceuticals. All product names, whether or not appearing in large print or with a trademark symbol, are trademarks of Jazz Pharmaceuticals or its licensors, unless otherwise noted. Nothing in this website shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, copyright, trademark or other intellectual property right of Jazz Pharmaceuticals or its licensors, or any third party.

5. User Submissions.

Your personal information may be transferred to countries located outside your country Pharmaceuticals emails, suggestions, comments, questions, information or materials, or otherwise provide feedback or information, which is referred to in these Terms of Use as “Content.” Except as otherwise provided in the Privacy Statement, any Content will be treated as non-confidential and non-proprietary and becomes the property of Jazz Pharmaceuticals. You agree that by submitting Content:

  1. except where specifically required, if you are a health care professional, you will not submit any Content that would directly identify a patient or any Content for which you do not have all necessary consents or authorizations to disclose;
  2. you will only submit Content that complies with applicable law and will not submit Content that is abusive, defamatory, obscene, infringing, threatening, repetitive or otherwise inappropriate, or that contains any viruses or other software that may adversely affect the operation of another’s computer; and
  3. except for information covered by our Privacy Statement, you grant to Jazz Pharmaceuticals the irrevocable right to use, copy, modify, publish, perform, transmit and display such Content via any media and waive any moral rights you may have in such Content, and you agree that Jazz Pharmaceuticals is free to use any ideas, concepts, know-how or techniques contained in the Content for any purpose whatsoever, including, but not limited to, developing, manufacturing and marketing products using such information.

6. Linking to the Website.

Unless otherwise set forth in a written agreement between you and Jazz Pharmaceuticals, you must adhere to Jazz Pharmaceuticals’ linking policy as follows: (i) any link to a Jazz Pharmaceuticals website must be a text only link clearly marked “Jazz Pharmaceuticals Website”; (ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Jazz Pharmaceuticals’ names and trademarks; (iii) the link must “point” to the root domain name of this website and only to the home page and not to other pages within this website; (iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, affiliated with, endorsed by or associated with Jazz Pharmaceuticals; (v) when selected by a user, the link must display this website on full-screen and not within a “frame” on the linking website; and (vi) Jazz Pharmaceuticals reserves the right to revoke its consent to the link at any time and in its sole discretion.

7. Third Party Websites.

This website may from time to time contain links to third party websites, which are provided for your information only. Jazz Pharmaceuticals is not responsible for, and accepts no liability in respect of, any information or opinion contained on any third party website. Jazz Pharmaceuticals has no control over such websites, and because their content is subject to change without notice to Jazz Pharmaceuticals, it is the responsibility of the user of the third party website to ensure that any information accessed is accurate and that any software that may be downloaded from that site is free of viruses or any other items of a destructive nature. Jazz Pharmaceuticals accepts no liability whatsoever in respect of any loss, damage, costs or liability incurred through any such downloaded material.

8. Disclaimer of Warranties.

By using this website, you accept the information provided herein “AS IS.” JAZZ PHARMACEUTICALS MAKES NO EXPRESS OR IMPLIED WARRANTY OR CONDITION REGARDING THE ACCURACY, CONTENT, COMPLETENESS, RELIABILITY, OPERABILITY OR LEGALITY OF INFORMATION CONTAINED WITHIN THE WEBSITE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT OF PROPRIETARY RIGHTS, OR THAT THIS WEBSITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS.

9. Limitation of Liability.

IN NO EVENT SHALL JAZZ PHARMACEUTICALS OR ITS AGENTS, AFFILIATES OR LICENSORS BE LIABLE FOR ANY DIRECT, SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR ANY DAMAGES WHATSOEVER, ARISING FROM OR IN CONNECTION WITH THE USE OF OR INABILITY TO USE THE WEBSITE, OR IN CONNECTION WITH THE USE OF INFORMATION OR MATERIALS CONTAINED ON THE WEBSITE, WHETHER IN AN ACTION OF CONTRACT, BREACH OF WARRANTY, NEGLIGENCE OR OTHER TORTIOUS ACTION. THIS LIMITATION ALSO INCLUDES DAMAGES TO YOUR COMPUTER EQUIPMENT OR DUE TO ANY VIRUSES OR OTHER TECHNOLOGICALLY HARMFUL MATERIAL THAT MAY INFECT YOUR HARDWARE, SOFTWARE OR DATA.

10. Controlling Law.

These Terms of Use, your access to and use of this website and any action related thereto will be governed and interpreted by and under the laws of the State of California, without giving effect to any principles that provide for the application of the law of another jurisdiction.

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LIMITATIONS OF USE AND SAFETY INFORMATION

Limitations of Use: SUNOSI is not indicated to treat the underlying obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI. SUNOSI is not a substitute for these modalities, and the treatment of the underlying airway obstruction should be continued.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of an MAOI, because of the risk of hypertensive reaction.

WARNINGS AND PRECAUTIONS

Blood Pressure and Heart Rate Increases

SUNOSI increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion. Epidemiological data show that chronic elevations in blood pressure increase the risk of major adverse cardiovascular events (MACE), including stroke, heart attack, and cardiovascular death. The magnitude of the increase in absolute risk is dependent on the increase in blood pressure and the underlying risk of MACE in the population being treated. Many patients with narcolepsy and OSA have multiple risk factors for MACE, including hypertension, diabetes, hyperlipidemia, and high body mass index (BMI).

Assess blood pressure and control hypertension before initiating treatment with SUNOSI. Monitor blood pressure regularly during treatment and treat new-onset hypertension and exacerbations of pre-existing hypertension. Exercise caution when treating patients at higher risk of MACE, particularly patients with known cardiovascular and cerebrovascular disease, pre-existing hypertension, and patients with advanced age. Use caution with other drugs that increase blood pressure and heart rate.

Periodically reassess the need for continued treatment with SUNOSI. If a patient experiences increases in blood pressure or heart rate that cannot be managed with dose reduction of SUNOSI or other appropriate medical intervention, consider discontinuation of SUNOSI.

Patients with moderate or severe renal impairment could be at a higher risk of increases in blood pressure and heart rate because of the prolonged half-life of SUNOSI.

Psychiatric Symptoms

Psychiatric adverse reactions have been observed in clinical trials with SUNOSI, including anxiety, insomnia, and irritability.

Exercise caution when treating patients with SUNOSI who have a history of psychosis or bipolar disorders, as SUNOSI has not been evaluated in these patients.

Patients with moderate or severe renal impairment may be at a higher risk of psychiatric symptoms because of the prolonged half-life of SUNOSI.

Observe SUNOSI patients for the possible emergence or exacerbation of psychiatric symptoms. Consider dose reduction or discontinuation of SUNOSI if psychiatric symptoms develop.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions (incidence ≥5%) reported more frequently with the use of SUNOSI than placebo in either narcolepsy or OSA were headache, nausea, decreased appetite, anxiety, and insomnia.

Dose-Dependent Adverse Reactions

In the 12-week placebo-controlled clinical trials that compared doses of 37.5 mg, 75 mg, and 150 mg/day of SUNOSI to placebo, the following adverse reactions were dose-related: headache, nausea, decreased appetite, anxiety, diarrhea, and dry mouth.

DRUG INTERACTIONS

Do not administer SUNOSI concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. Concomitant use of MAOIs and noradrenergic drugs may increase the risk of a hypertensive reaction. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.

Concomitant use of SUNOSI with other drugs that increase blood pressure and/or heart rate has not been evaluated, and combinations should be used with caution.

Dopaminergic drugs that increase levels of dopamine or that bind directly to dopamine receptors might result in pharmacodynamic interactions with SUNOSI. Interactions with dopaminergic drugs have not been evaluated with SUNOSI. Use caution when concomitantly administering dopaminergic drugs with SUNOSI.

USE IN SPECIFIC POPULATIONS

Renal Impairment

Dosage adjustment is not required for patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m2). Dosage adjustment is recommended for patients with moderate to severe renal impairment (eGFR 15-59 mL/min/1.73 m2). SUNOSI is not recommended for patients with end stage renal disease (eGFR <15 mL/min/1.73 m2).

ABUSE

SUNOSI contains solriamfetol, a Schedule IV controlled substance. Carefully evaluate patients for a recent history of drug abuse, especially those with a history of stimulant or alcohol abuse, and follow such patients closely, observing them for signs of misuse or abuse of SUNOSI (e.g., drug-seeking behavior).

INDICATIONS AND USAGE

SUNOSI is indicated to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA).

Please see full Prescribing Information.


LIMITATIONS AND SAFETY INFO

LIMITATIONS OF USE AND IMPORTANT SAFETY INFORMATION

Limitations of Use: SUNOSI is not indicated to treat the underlying obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI. SUNOSI is not a substitute for these modalities, and the treatment of the underlying airway obstruction should be continued.