Last updated: July 17, 2015

Thank you for your interest in Meda Pharmaceuticals Inc. Meda invites you to explore our websites and learn more about us and our products. As you do so, please know that Meda respects your privacy and is committed to protecting the personal information that you share with us. This Privacy Policy summarizes our standards for collecting, using, storing and sharing the personal information that we, or companies that work with us, obtain from our websites.

Meda Pharmaceuticals Inc. is the United States subsidiary of Meda AB, a global specialty pharmaceutical company based in Sweden. This Privacy Policy applies only to Meda Pharmaceuticals Inc., and to Meda owned websites, and the data collected within those websites, specifically identified as intended for use only by residents of the United States and its territories that link to this policy.

Meda’s Privacy Policy does not apply to third–party online resources, even if our website offers courtesy links to them. Meda does not control the content or the privacy practices of third–party resources. Read the Privacy Policy of any website or other online resource that you visit to ensure that you understand and agree with it. (That applies to our Privacy Policy too – we want you to read it carefully). If you have questions about our policy, or how Meda protects the privacy of your personal information, you may contact us a

Meda Pharmaceuticals, Inc. reserves the right to update or change this Privacy Policy.

The term "personal information" is used to describe information that can be readily used to identify a specific living person. Examples of personal information that could potentially be collected within a Meda website include an individual’s name, an individual’s street address or an individual’s email address. Information that relates to an individual, but could not be used to identify a specific individual, is not considered “personal information”. For example, the state of residence alone would not be considered personal information, but if this were to be combined with an individual’s street address, this would be considered “personal information” as it could be used to identify a specific individual.

De–identified information is information that has been stripped of features that would permit the identification of the underlying individual. When de–identified information about multiple people is put together, it is referred to as "aggregated" and de–identified information. Meda reserves the right to choose to aggregate personal information obtained from individuals through a variety of different channels. Any data aggregation of personal information will be done in a manner consistent with this Privacy Policy and any additional privacy notifications provided.

Meda collects personal information to improve your experience as a user of Meda’s websites. Collected personal information enables Meda to provide topics of interest that are more relevant to you as a user. In addition, information collected via Meda websites can provide mechanisms to assist with the improvement of Meda products and services as well as help better design features and better identify resources that users would like to see Meda offer.

Meda collects personal information online through websites and other sponsored resources. At times, we will work with other companies that collect personal information at our request. When Meda works with a third party company, the work is regulated by an agreement that, among other things, requires the third party company to properly protect the personal information it collects for us.

There are an assortment of tools that Meda may employ to collect personal information, including, but not limited to:

Direct Collection. This is collecting personal information from you by requesting that you complete an online form or participate in an interactive survey or display. Contact details, such as your name, street address, email address, telephone number, birth date, etc. are often collected directly. So is health status, so that Meda can provide you with information that is more likely to be relevant.

"Cookies". At times Meda, and at times advertisers on our websites, will employ the use of cookies. A "cookie" is a data file that a website may place on your computer’s hard drive. In general, cookies are used to simplify and improve your communication and interaction with a website. A website sponsor's ability to use a cookie to retrieve information from your computer can help customize the presentation of products and services, or help the website sponsor enhance their services to you. Some cookies are temporary and erased when you leave the Internet or shut down; others stay on your computer unless or until they are removed. If you do not wish to receive cookies from Meda websites, you can adjust your Web browser’s preferences on your computer. Please be aware that you can still visit our websites if you refuse cookies; but you may find that some of the features do not work, or do not work as well. Meda does not use cookies to retrieve information from your computer unless the information is related to our website or your interaction with our website.

Meda may use Google Analytics, a third party provider of analytics tools or a similar third party service to analyze information about visits to our website. For information about opting out of Google Analytics, please visit

Some Internet browsers offer what often is referred to as "do not track" mechanisms for browser users to automatically signal privacy preferences to websites that they visit. Internet browsers have only begun to include these features relatively recently. Our website(s) do not currently respond to do-not-track-signals. We may revisit the issue in the future. In the meantime, however, you can exercise other choices available, including limiting the placement of browser cookies on your device using your browser's cookie control features and other choices described in this Policy.

Web pixels. These are tiny graphics similar to cookies. Web pixels collect information that cannot be used to identify you personally such as the addresses of websites you view, the website that you viewed immediately prior to visiting our website, or the address of the website where the link used to reach our website was accessed. In addition, web pixels can be used to monitor whether email communications have been opened.

In general, Meda websites are not directed at children and most of the online services offered by Meda are designed for adults, age 18 or older.

Where available, you may update personal information by modifying information that was previously entered into either a Web form or data fields located within a Meda website. If you wish to access personal information collected by Meda, you may contact for purposes of ensuring accuracy or completeness of personal information. Please be aware that you may not always be able to access the information that has been collected. For instance, your ability to access and correct personal information will be limited where we believe it would interfere with our ability to fulfill legal or ethical obligations or to address legal claims. Access and correction of personal information will not be allowed if it would result in disclosure of a third party's personal information, or lead to a breach of contract or disclosure of trade secrets or other protected business information.

Meda strives to protect personal information as it is transmitted from your computer to our websites. Due to the open nature of the Internet, Meda cannot guarantee that our interactions with you, or your interactions with Meda, will be free from unauthorized access by third parties. Meda protects our servers and data with a firewall and endeavors to protect personal information within our possession, custody, or control from unauthorized access, disclosure, alteration or destruction. Employees and business partners with access to your personal information must have a business–related "need to know" in order to perform their job functions for Meda. However, Meda also depends upon you to help secure information by protecting your own copies of passwords and related access codes for our websites.

Personal information is accessible to Meda, including its subsidiaries, divisions and groups worldwide, and to individuals and organizations that use personal information solely for, and at the direction of, Meda. Uses and disclosures of personal information by external individuals and organizations acting on Meda's behalf are governed by agreements that require personal information to be protected appropriately. Personal information about you only will be used and disclosed by Meda and individuals and organizations working on its behalf, in a manner consistent with this Privacy Policy, other applicable privacy notices, and as explicitly permitted or required by applicable laws, rules and regulations.

In general, Meda does not sell or barter your personal information to third parties. However, if Meda decides to reorganize or divest its business through sale, merger or acquisition, it is possible that personal information will be shared with actual or prospective buyers. If that happens, Meda will obtain a written agreement that personal information will be properly protected. Except where explicitly permitted, required by law, or provided in this Privacy Policy, personal information will not otherwise be shared without your consent.

You will have some choices about whether and/or when to share personal information with Meda. In cases where you are affirmatively requested to provide information, such as to complete a form, a survey, or application on a Meda website, you may decline to do so. Please understand, however, that in some cases certain information is required to complete an application, form, or survey, and if you decline to provide the information requested, you may not be able to use certain functionalities of our websites.

In addition, you may be given additional choices in the context of particular preferences tools or functions that are made available through Meda’s websites or opportunities to opt-out of future email or other communications using the opt-out choices offered within those communications.

More Important Safety Information

  • Edluar is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema. Cases of angioedema involving the tongue, glottis, or larynyx have been reported in patients after the first or subsequent doses of sedative-hypnotics, including zolpidem tartrate. Some patients have had additional symptoms such as dyspnea, throat closing, nausea, and vomiting that suggest anaphylaxis. Airway obstruction may occur and be fatal. Patients who develop angioedema should not be rechallenged with the drug.
  • Edluar has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of Edluar and of other concomitant CNS depressants may be necessary when administered together because of the potentially additive effects. The use of Edluar with other sedative-hypnotics is not recommended.
  • The risk of next-day psychomotor impairment, including impaired driving, is increased if Edluar is taken with less than a full night of sleep remaining, if a higher than the recommended dose is taken, if co-administered with other CNS depressants, or if coadministered with other drugs that increase the blood level of Edluar. Patients should be cautioned against driving and other activities requiring complete mental alertness if taken in these circumstances.
  • Symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
  • Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including zolpidem (e.g., aggressiveness, extroversion that seems out of character, bizarre behavior, agitation, depersonalization, visual and auditory hallucinations). Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. The use of alcohol or other CNS depressants increases the risk of such behaviors. Discontinuation of Edluar should be strongly considered for patients who report a "sleep-driving" episode. 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. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
  • In primarily depressed patients treated with sedative-hypnotics, worsening depression, and suicidal thoughts and actions (including complete suicides), have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.
  • Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if Edluar is prescribed to patients with compromised respiratory function including sleep apnea and myasthenia gravis.
  • There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence.
  • During short-term treatment (up to 10 nights), the most common adverse reactions in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights), the most common adverse reactions were dizziness (5%) and drugged feelings (3%).
  • Imipramine used in combination with zolpidem produced an additive effect of decreased alertness. Similarly, chlorpromazine used in combination with zolpidem produced impaired alertness and psychomotor performance.
  • Use of rifampin, a CYP3A4 inducer, in combination with zolpidem may decrease the efficacy of zolpidem.
  • Use of ketoconazole, a potent CYP3A4 inhibitor, in combination with zolpidem increased the phamacodynamics effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together.
  • There are no adequate and well-controlled studies of Edluar in pregnant women. Edluar should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
  • Zolpidem is excreted in human milk. Caution should be exercised when Edluar is administered to a nursing woman.
  • Edluar is not recommended for use in children. Safety and effectiveness in pediatric patients have not been established in pediatric patients below the age of 18.
  • Edluar contains zolpidem tartrate, a Schedule IV controlled substance.
  • Use the lowest effective dose for the patient.
  • The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. The maximum recommended dose of Edluar is 10 mg once daily immediately before bedtime.
  • The recommended dose of Edluar in geriatric patients and patients with hepatic impairment is 5 mg once daily immediately before bedtime.
  • Lower doses of CNS depressants may be necessary when taken concomitantly with Edluar.
  • The effect of Edluar may be slowed if taken with or immediately after a meal.
  • Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.


Edluar (zolpidem tartrate) sublingual tablets, a gamma-aminobutyic acid (GABA) A agonist, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.

To report adverse events or product complaints, please call Meda's pharmacovigilance team at (855) 365-6095 or the FDA at 1-855-543-3784 or visit