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Full Prescribing Information

Medication Guide

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SAVE ON QUVIVIQ
SAVE ON QUVIVIQ
QUVIVIQ

QUVIVIQ is a prescription treatment for adults who have trouble falling asleep or staying asleep (insomnia).

SMS Terms u0026amp; Conditions

u003cspanu003eHow Does the Program Work?u003c/spanu003e

Individuals can enroll in the SMS Program (the “Program”) via an online registration form. Individuals can select the option to receive SMS text messages. All individuals enrolled in the Program will receive an enrollment confirmation text message. Message and data rates may apply. Message frequency will vary. Idorsia Pharmaceuticals (“Idorsia”) reserves the right to alter the frequency of messages sent at any time, so as to increase or decrease the total number of sent messages. Idorsia also reserves the right to change the short code or phone number from which messages are sent and we will notify you when we do so.

Your Consent to These Terms and Conditions:

By replying with a “YES” text message to confirm your participation in the SMS Program, you are consenting to the Terms and Conditions set forth below, with respect to receiving autodialed text messages sent from or on behalf of Idorsia. You agree that your response text is your electronic signature and provides electronic written consent. Consent is not a condition of purchase or use of any Idorsia product or service. Idorsia reserves the right to rescind, revoke or amend the Program without notice to you.

Use and Disclosure of Your Personal Information:

Data obtained from you in connection with the Program may include your phone number, and related carrier information. This information may be used to administer the Program, including Program updates and alerts sent directly to your mobile device. Please see our u003ca href=u0022https://www.idorsia.us/us/system/legal-statements/privacy-policy.pageu0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eu003cstrongu003eu003cspan style=u0022text-decoration: underline;u0022u003ePrivacy Policyu003c/spanu003eu003c/strongu003eu003c/au003e for more general information on how we may collect, use and disclose personal information about you.

Text Messages Sent to You:

The Program is valid with most major US carriers, but not all cellular phone providers carry the necessary service to participate. Participating Carriers: ATu0026amp;T, Verizon Wireless, T-Mobile/Sprint/Metro PCS, CellCom USA, C Spire Wireless, U.S. Cellular, Carolina West Wireless (CWW), Google Voice, ACS/Alaska, Advantage Cellular (DTC Wireless), Appalachian Wireless, Bluegrass Cellular, Cellular Network Partnership (PIONEER), Cellular One of East Central Illinois, Chat Mobility USA, Coral Wireless (Mobi PCS), Element Mobile (Flat Wireless), Epic Touch (Elkhart Telephone), GCI Communications Corp, Golden State Cellular, Illinois Valley Cellular (IV Cellular), i Wireless (IOWA Wireless), Nex-Tech Wireless, MTA Communications, MTPCS (Cellular One Nation), Cross Telephone Company (MBO Wireless), Duet IP (Maximum Communications New Core Wireless), Inland Cellular Telephone Company, Immix (Keystone Wireless), Mosaic (Consolidated or CTC Telecom), Northwest Missouri Cellular Limited, Peoples Wireless, Panhandle Telecommunications Systems (PTCI), RINA, Revol Wireless USA, SI Wireless/Mobile Nation, SRT Wireless, Texas RSA 3 Ltd (Plateau Wireless), Thumb Cellular, United Wireless, Union Telephone Company (Union Wireless), Viaero Wireless, West Central Wireless (5 Star Wireless), Sagebrush Cellular (Nemont), Pine Cellular, Aio Wireless/Cricket, SouthernLinc, Bandwidth, Copper Valley, Leaco, CableVision, Buffalo Wireless, Chariton Valley Cellular, Pine Belt Wireless, Atlantic Tele-Network International (ATN). T-Mobile is not liable for delayed or undelivered messages. The service is offered on an “as-is” basis and may not be available in all areas at all times and may not continue to work in the event of product, software, coverage or other changes made by your wireless carrier. Carriers are not responsible for delayed or undelivered messages. Check your phone capabilities for specific text messaging instructions. There is no fee charged to you for receiving Program messages that is payable to Idorsia or anyone acting on its behalf; however, your carrier’s message and data rates may apply depending on your individual wireless pricing plan, in accordance with your wireless customer agreement. You are responsible for all applicable taxes. Consult your wireless service provider regarding its pricing plans.

Participant Opt-Out or Help:

You may opt out from participating in the Program at any time. Text u003cstrongu003eSTOPu003c/strongu003e to u003ca href=u0022sms:79702u0022u003e79702u003c/au003e or reply u003cstrongu003eSTOPu003c/strongu003e to any message to opt out. For help, text u003cstrongu003eHELPu003c/strongu003e to u003ca href=u0022sms:79702u0022u003e79702u003c/au003e or reply u003cstrongu003eHELPu003c/strongu003e to any message or call u003ca href=u0022tel:8889717050u0022u003e888-971-7050u003c/au003e.

What is QUVIVIQ (daridorexant)?

QUVIVIQ is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).

Important Safety Information

Do not take QUVIVIQ if you fall asleep often at unexpected times (narcolepsy) or if you are allergic to QUVIVIQ or any of its ingredients.

QUVIVIQ may cause serious side effects, including:

  • Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.

What is QUVIVIQ (daridorexant)?

QUVIVIQ is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).

 

Important Safety Information

Do not take QUVIVIQ if you fall asleep often at unexpected times (narcolepsy) or if you are allergic to QUVIVIQ or any of its ingredients.

 

QUVIVIQ may cause serious side effects, including:

  • Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Sleepiness may increase your risk of falls.
  • Do not take more QUVIVIQ than prescribed.
  • Do not take QUVIVIQ unless you are able to stay in bed for at least 7 hours before you must be active again.
  • Take QUVIVIQ at night within 30 minutes before going to bed.

 

QUVIVIQ is a federally controlled substance because it can be abused or lead to dependence.

 

Before taking QUVIVIQ, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of depression, mental illness, or suicidal thoughts or actions; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness
  • have lung or breathing problems, including sleep apnea
  • have liver problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

 

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Taking QUVIVIQ with certain medicines can cause serious side effects. QUVIVIQ may affect the way other medicines work and other medicines may affect the way QUVIVIQ works.
  • Do not take QUVIVIQ with other medicines that can make you sleepy unless instructed by your healthcare provider.

 

What should I avoid while taking QUVIVIQ?

  • Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous.
  • Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you do not feel fully awake, or you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed.

 

QUVIVIQ may cause other serious side effects, including:

  • Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
  • Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
  • Temporary weakness in your legs that can happen during the day or at night.
  • Complex sleep behaviors such as sleepwalking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior.

 

The most common side effects of QUVIVIQ are headache and sleepiness or tiredness.

 

These are not the only side effects of QUVIVIQ. Call your doctor for advice about side effects.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please see full Prescribing Information and Medication Guide.