Introduction

Galt Pharmaceuticals, LLC (referred to as "Company," "we," us," or "our") respects your privacy and is committed to protecting it through our compliance with this policy.

This privacy policy ("Privacy Policy") describes the types of information we may collect from you or that you may provide when you visit the website doralrx.com (our "Site") and our practices for collecting, using, maintaining, protecting, and disclosing that information.

This Site is intended for patients or visitors in the United States.

This policy applies to information we collect:

  • On this Site.
  • In email, text, and other electronic messages between you and this Site.
  • When you interact with our advertising and applications on third-party websites and services, if those applications or advertising include links to this policy.

It does not apply to information collected by:

  • Us offline or through any other means, including on any other website operated by Company or any third party (including our affiliates and subsidiaries) or provided by you through voluntary responses to emails; or
  • Any third party, including through any website, application, or content that may link to or be accessible from this Site.

Please read this Privacy Policy carefully to understand our policies and practices regarding your information and how we will treat it. If you do not agree with our policies and practices, your choice is not to use our Site. By accessing or using this Site, you agree to this Privacy Policy. This policy may change from time to time. Your continued use of this Site after we make changes is deemed to be acceptance of those changes, so please check this Privacy Policy periodically for updates.

Children Under the Age of 16

Our Site is not intended for children under 16 years of age. No one under the age of 16 may provide any personal information on the Site. We do not knowingly collect personal information from children under 16. If you are under 16, do not use or provide any information on this Site. If we learn we have collected or received personal information from a child under 16 without verification of parental consent, we will use commercially reasonable means to delete that information. If you believe we might have any information from or about a child under 16, please contact us by emailing galtdirect@galtrx.com or by calling (855)-965-2783.

Information We Collect About You and How We Collect It

We may collect several types of information from and about users of our Site, including information:

  • By which you may be identified and is generally accepted as basic personal information, such as name, age, gender, or e-mail address.
  • That is about you but individually does not identify you, such as voluntary responses to quizzes, surveys, or other interactive features on this Site.
  • About your internet connection, the equipment you use to access our Site, and usage details.

We collect this information:

  • Directly from you when you provide it to us.
  • Automatically as you navigate through the site. Information collected automatically may include usage details, IP addresses, and information collected through cookies or similar tracking technologies.

Information You Provide to Us

The information we collect on or through our Site may include, but is not limited to:

  • Information that you provide by filling in forms on our Site. This includes information provided at the time of requesting further services or resources. We may also ask you for information when you report a problem with our Site.
  • Records and copies of your correspondence (including email addresses), if you choose to contact us.
  • Your responses to surveys that we might ask you to complete for research purposes, in the aggregate with other users’ responses to surveys.

Notwithstanding the foregoing, Galt does not knowingly collect, request, or obtain any personally identifiable information related to your medical history, health, or finances. Nothing on this Site is intended to solicit any such information and by interacting with our Site, you agree not to provide any sensitive or personally identifiable medical, health, or financial information.

Information We Collect Through Automatic Data Collection Technologies

As you navigate through and interact with our Site, we may use automatic data collection technologies to collect certain information about your equipment, browsing actions, and patterns, including:

  • Details of your visits to our Site, including general location data and other communication data and the resources that you access and use on the Site.
  • Information about your computer and internet connection, including your IP address, operating system, and browser type.

The information we collect automatically is only statistical data and does not include personal information, such as the number of visitors to this Site, but we may maintain it or associate it with personal information we collect in other ways. It helps us to improve our Site and to deliver a better and more personalized service, including by enabling us to estimate our audience size and usage patterns.

The technologies we use for this automatic data collection may include:

  • Cookies (or browser cookies). A cookie is a small file placed on the hard drive of your computer. You may refuse to accept browser cookies by activating the appropriate setting on your browser. However, if you select this setting you may be unable to access certain parts of our Site. Unless you have adjusted your browser setting so that it will refuse cookies, our system will issue cookies when you direct your browser to our Site.
  • Web Beacons. Pages of the Site and our e-mails may contain small electronic files known as web beacons (also referred to as clear gifs, pixel tags, and single-pixel gifs) that permit the Company, for example, to count users who have visited those pages or opened an email and for other related Site statistics (for example, recording the popularity of certain Site content and verifying system and server integrity).

How We Use Your Information

We use information that we collect about you or that you provide to us, including any personal information:

  • To present our Site and its contents to you.
  • To provide you with information, products, or services that you request from us.
  • To send periodic emails if you choose to subscribe to our mailing list.
  • To fulfill any other purpose for which you provide it.
  • To allow you to participate in interactive features on our Site.
  • In any other way we may describe when you provide the information.
  • For any other purpose with your consent.

Disclosure of Your Information

We may disclose aggregated information about our users (e.g., information that does not identify any individual, such as the number of visitors to this Site) without restriction.

Any communication or material you transmit to the Site by electronic mail or otherwise, including any data, questions, comments, suggestions or the like is, and will be treated as, non-confidential and nonproprietary. Anything you transmit becomes the property of the Company and may be used for any purpose, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and posting. Any personal information you provide is on a voluntary basis and not required to access or use this Site.

We may disclose personal information that we collect or you provide as described in this Privacy Policy:

  • To our parent company, subsidiaries, and affiliates.
  • To contractors, service providers, and other third parties we use to support our business and who are bound by contractual obligations to keep personal information confidential and use it only for the limited purposes for which we disclose it to them.
  • To a buyer or other successor in the event of a merger, divestiture, restructuring, reorganization, dissolution, or other sale or transfer of some or all of Galt's assets, whether as a going concern or as part of bankruptcy, liquidation, or similar proceeding, in which personal information held by us about our Site's users is among the assets transferred.
  • To fulfill the purpose for which you provide it. For example, if you give us an email address to send you the results of a voluntary quiz on this site, we will transmit the contents of that quiz to your email address.
  • For any other purpose disclosed by us when you provide the information.
  • With your consent.

We may also disclose your personal information:

  • To comply with any court order, law, or legal process, including to respond to any government or regulatory request.
  • To enforce or apply our terms of use (available here) and expressly incorporated herein (“Terms of Use”).
  • If we believe disclosure is reasonably necessary or appropriate to protect the rights, property, or safety of the Company, our customers, or others.

Choices About How We Use and Disclose Your Information

We strive to provide you with choices regarding the personal information you provide to us. We have created mechanisms to provide you with the following control over your information:

  • Tracking Technologies. You can set your browser to refuse all or some browser cookies, or to alert you when cookies are being sent. If you disable or refuse cookies, please note that some parts of this site may then be inaccessible or not function properly.

We do not control third parties' collection or use of your information to serve interest-based advertising. However these third parties may provide you with ways to choose not to have your information collected or used in this way.

Unfortunately, the transmission of information via the internet is not completely secure. Although we use commercially reasonable means to protect any personal information you provide, we cannot guarantee the security of your personal information transmitted to our Site. Any submission of personal information is at your own risk. We are not responsible for circumvention of any privacy settings or security measures contained on the Site.

Changes to Our Privacy Policy

It is our policy to post any changes we make to our Privacy Policy on this page. If we make material changes to how we treat our users' personal information, we will notify you through a notice on the Site's home page. The date the Privacy Policy was last revised is identified at the top of the page. You are responsible for periodically visiting our Site and this Privacy Policy to check for any changes.

Miscellaneous

Third party websites linked to from this Site may each have different terms of use, privacy policies, and practices. You should carefully review these other sites' terms of use, privacy policies, and other practices in order to determine how each site may use any personal information you provide. This Privacy Policy applies solely to information collected through the Site and not through any other websites or sources.

In addition to the rights and privileges described in this Privacy Policy or the Terms of Use (hereby incorporated herein), Galt Parties reserve the right to elect to electronically monitor areas of the Site and may disclose any information, content, records of any kind if required to do so by law, regulation or government request, if such disclosure is necessary or appropriate to operate the Site, or to protect our rights or property, or the rights of the users, partners, affiliates, licensors, or other third parties.

You expressly agree that the exclusive jurisdiction for any dispute with Galt Parties, or in any way relating to your use of the Site, shall be in the courts in Cobb County in the State of Georgia and you further agree and expressly consent to the exercise of personal jurisdiction in the courts of the State of Georgia. This Privacy Policy shall be construed and are governed by the laws of the State of Georgia, without respect to its conflict of laws principles.

If any provision of this Privacy Policy is found unenforceable by a court of competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions.

No waiver of any of these terms or conditions shall be deemed a further or continuing waiver of such term or any other term or condition.

This Privacy Policy and the Terms of Use for this Site constitute the entire agreement between you and Galt with respect to the use of the Site.

If you have any questions or comments regarding this Privacy Policy and our privacy practices, please contact us by emailing galtdirect@galtrx.com or by calling (855)-965-2783.




Indications

DORAL® (Quazepam) is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

The effectiveness of Doral® has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of Doral® has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of Doral® tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.


What Pharmacies Carry Doral®?

Doral® is available at many independent and retail pharmacies. If you are unable to find this product locally, Sterling Specialty Pharmacy is able to mail to patients across the US.

Should your healthcare provider choose to prescribe Doral®, click here to download an information sheet to give to them.

E-scribe #: 2433693
Pharmacy Name: Sterling Specialty Pharmacy, Mendota Heights, MN
Phone Number: 888-618-4126
Fax Number: 866-588-0371



Important Safety Information ▲ expand
Indications & Usage ▲ expand

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS. See full prescribing information for complete boxed warning.

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation (5.1, 7).
  • The use of benzodiazepines, including DORAL®, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing DORAL® and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (5.2).
  • Abrupt discontinuation or rapid dosage reduction of DORAL® after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue DORAL® or reduce the dosage (2.3, 5.3).

CONTRAINDICATIONS

DORAL® is contraindicated in patients with known hypersensitivity to DORAL® or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of DORAL®. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should be treated in an emergency department and should not be rechallenged with DORAL®.

DORAL® is contraindicated in patients with established or suspected sleep apnea, or with pulmonary insufficiency.

 

WARNINGS AND PRECAUTIONS

CNS-Depressant Effects and Daytime Impairment: Doral® can produce CNS depressant effects, including daytime impairment. Patients should be cautioned against driving and other activities requiring complete mental alertness. Alcohol generally should not be used during treatment with DORAL®. Additive effects occur with concomitant use of other CNS depressants. There is an increased risk of next-day psychomotor impairment if higher than the recommended dose is taken, if co-administered with other CNS depressants, or if taken with less than a full night of sleep remaining (7-8 hours). The use of Doral® and concomitant CNS depressants may require downward dose adjustment and the concomitant use of Doral® with other sleep-hypnotics is not recommended.

Because DORAL® can cause drowsiness and a decreased level of consciousness, patients particularly the elderly, are at higher risk of falls.

Need to Evaluate for Co-morbid Diagnoses: If insomnia worsens or fails to remit after 7 to 10 days of treatment, this might be indication of an underlying illness that should be evaluated.

Abnormal Thinking and Behavior Changes: Abnormal thinking, behavior changes, and complex behaviors such as “sleep driving” (i.e., driving while not fully awake, with amnesia for the event) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events. Some of these changes include decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), bizarre behavior, and depersonalization. Visual and auditory hallucinations have also been reported. Doral® should be discontinued if these symptoms occur.

Worsening of Depression: Benzodiazepines may worsen depression and consequently, appropriate precautions (e.g., increased monitoring for suicidal ideation, limiting prescription size) should be considered.

 

ADVERSE REACTIONS

The most common adverse reactions (>1%) observed with DORAL® were drowsiness, headache, fatigue, dizziness, dry mouth, and dyspepsia. Doral® is classified as a Schedule IV controlled substance and patients treated with Doral® should be monitored for tolerance, abuse, and dependence. For a full list of warnings and precautions, please refer to the full prescribing information.

DORAL® contains quazepam, a Schedule IV controlled substance.