These Terms of Use were last updated on April 28, 2021.

1. General

1.1. Your access to and use of the Doral website (www.doralrx.com) and the information and services accessible by and made available on or through the Doral website, including any information provided by and communicated to you on or through the Doral website (all of the foregoing, collectively, the “Site”) are subject to the following terms and conditions and all applicable laws. By using, accessing, and browsing this Site, you accept, without limitation or qualification, these Terms of Use.

1.2. Galt Pharmaceuticals, LLC (“Galt”, and collectively with its affiliates, “Galt Parties”) may at any time amend these Terms of Use by updating this posting, so you should visit this page from time to time to be aware of any such changes. Your continued use of this Site after any changes to these Terms of Use are posted will be considered acceptance of those terms.

2. No Medical or Pharmaceutical Advice

2.1. This Site does not provide medical or pharmaceutical advice. The contents on this Site are intended for general informational and educational purposes only and are not intended to be a substitute for professional medical advice, diagnosis, or treatment.

2.2. Any decisions regarding the use of any pharmaceutical products or other information referenced on this Site should be based on the independent judgment of your healthcare provider. Though this Site may provide links to third-party websites and resources (for example, telehealth to facilitate an introduction or otherwise connect you with a healthcare provider) Galt Parties are not responsible for any professional medical advice, treatment plan, procedures, tests, or other information from such third parties and do not endorse, recommend, or otherwise affirm any such information.

2.3. Call 911 immediately if you think you may be experiencing a medical emergency.

3. Disclaimer of Warranties

3.1. While Galt Parties use reasonable efforts to include accurate and up to date information in the Site, Galt Parties make no warranties or representations with respect to the content of the Site or the information contained therein. This Site is provided on an “AS IS” basis. Galt Parties will not be liable for the accuracy, completeness, adequacy, timeliness, or comprehensiveness of the Site and is under no duty, express or implied, to update this Site as new information becomes available. Galt Parties reserve the right to correct any errors, omissions, or inaccuracies in the Site. Galt Parties are not responsible for any claim, loss or damage directly or indirectly resulting from your use of the Site. Galt Parties are not responsible for any inaccuracy of the Site and Galt Parties are not responsible and do not accept any liability for the consequences arising from the application, use, or misuse of the Site, including any injury or damage to any person or property as a matter of product liability, negligence or otherwise.

3.2. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, GALT PARTIES DISCLAIM ALL EXPRESS OR IMPLIED REPRESENTATIONS OR WARRANTIES, INCLUDING BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THIRD PARTIES’ RIGHTS, AND MERCHENTABILITY.

3.3. Galt Parties assume no responsibility, and shall not be liable for, any damages to, or viruses that may infect, your computer equipment or other property on account of your access to, use of, or browsing in the Site or your downloading of any materials, data, text, images, video, or audio from the Site. Galt Parties reserve the right to interrupt or discontinue any or all of the functionality of its Site. Galt Parties accept no responsibility or liability whatsoever for any interruption or discontinuance of any or all functionality of or access to the Site or the Information, whether the result of actions or omissions of this entity or a third party.

3.4. The Site may contain technical inaccuracies or typographical errors. Galt Parties reserve the right, but accept(s) no obligation, to make changes, corrections and/or improvements to the Site, at any time without notice.

4. Content

4.1. The content on this site is subject to copyright protection and may not be used except as provided in these Terms of Use without the written permission of Galt. You may print or download information solely for your personal, noncommercial, nonpublic use only if you retain and reproduce every copyright notice (e.g., ©2021 Galt Pharmaceuticals, LLC). You may not, however, distribute, modify, transmit, reuse, repost, or use the content of the Site for public or commercial purposes, including the text, images, audio, and video without written permission of Galt.

4.2. With the exception of the foregoing limited authorization, no license to or right in any copyrighted material of Galt Parties or of any other party is granted or conferred to you. The Site may contain or reference trademarks, patents, proprietary information, technologies, products, processes or other proprietary rights owned or licensed by Galt, the Galt Parties, or other third parties. No implied or express license to or right in any such trademarks, patents, trade secrets, technologies, products, processes and other proprietary rights of Galt or other parties is granted to or conferred upon you. Galt Parties neither warrant nor represent that your use of materials displayed on the Site will not infringe rights of third parties not owned by or affiliated with Galt Parties.

5. Limitation of Liability

5.1. To the maximum extent permitted by applicable law, in no event shall Galt Parties (including their owners, officers, directors, employees, or other representatives) be liable, directly or indirectly, for any damages of any kind, including but not limited to, direct, indirect, consequential, incidental, special, punitive damages, or any damages whatsoever, resulting from any loss related to or arising from your use of this Site.

5.2. You acknowledge and agree that the limitations as set forth above are material elements of this agreement and the Site would not be made available to you absent such limitations. The use of this Site is at your own risk.

6. No Confidentiality; Personal Information

6.1. 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 or post becomes the property of Galt and may be used for any purpose, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and posting. Any information you provide is on a voluntary basis and not required to access this Site.

6.2. Other than the basic information we may request to provide you access to various resources on this Site (e.g., email, first name, age, etc.) you agree to not provide Galt Parties, in any communication or material, any personally identifiable information, including any medical, health, or financial information.

6.3. Certain non-personal information of visitors to this Site may be recorded by the standard operation of Galt’s Internet servers. Galt may use “cookies” and other tracking mechanisms to collect this information. This information is primarily used to provide an enhanced website experience for any visitors. Information tracked includes the type of browser being used by the visitor, the Internet address of the site you came from, the type of operating system in use by the visitor, the date and time of your access and the pages you visit, and the domain name of the visitor’s Internet service provider. By having this information, webpages optimized for a particular user’s computer are automatically made available to that user. Other use of this information may include internal review of the number of visitors to this Site, but only in an aggregate form. If you do not want to receive cookies, you may set your browser to reject them. Please note, turning cookies off may interfere with your ability to access all of the features of this Site.

6.4. Please review our Privacy Policy for more information.

7. Indemnification

You agree to indemnify, defend and hold harmless Galt Parties (including their owners, directors, officers, employees, and representatives) from and against any liability, claim, loss, expense (including reasonable attorney’s fees) related to or arising from your use of the Site or your violation of these Terms of Use.

8. Miscellaneous

8.1. This Site is not intended or designed to attract or be used by children under the age of 16. Galt Parties do not knowingly collect information from any child under the age of 16. You should not use or access this Site unless you are at least 16 years of age or older. If a child under 16 has provided any personal information on this Site, a parent or guardian may contact Galt via email at galtdirect@galtrx.com or by calling (855)-965-2783 and Galt will use commercially reasonable efforts to delete it from our databases, subject to applicable law.

8.2. 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 websites’ terms of use, privacy policies, and other practices in order to determine how each website may use any personal information you provide. These Terms of Use apply solely to information collected through the Site and not through any other websites or sources.

8.3. In addition to the rights and privileges described in these Terms of Use or the Privacy Policy, 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.

8.4. 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. These Terms of Use shall be construed and are governed by the laws of the State of Georgia, without respect to its conflict of laws principles.

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

8.6. 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.

8.7. These Terms of Use and the Privacy Policy incorporated herein constitute the entire agreement between you and Galt with respect to the use of the Site.

8.8. If you have any questions or comments regarding the Site, please contact Galt at galtdirect@galtrx.com or (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.