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Galt Pharmaceuticals® Introduces New Convenient Package Size for Insomnia Drug

September 24, 2019

ATLANTA (September 24, 2019) – Galt Pharmaceuticals® announced the availability of a new convenient package size of 30 count bottles for Doral 15mg, making the insomnia treatment more accessible to pharmacies and patients across the country. 

According to a recent study by the University of Pennsylvania School of Medicine that was reported in Science Daily, one in four Americans experience acute insomnia each year. Although many medications are available, Doral offers an alternative that has FDA indications for all three symptoms associated with insomnia: difficulty falling asleep, difficulty maintaining sleep and early morning awakenings. The new bottle size offers pharmacies a more efficient way to dispense Doral. The bottles will be available through all major wholesalers: Cardinal Health, McKesson and AmerisourceBergen.

Doral 15mg was re-launched by Galt in 2016 and prescriptions are growing exponentially each month. Doral serves unmet needs for Americans suffering from insomnia who have not found relief with current medications on the market. 

“As more and more healthcare providers learn about Doral and try their patients on it for the first time, we want pharmacies to have a smaller package size so they aren’t taking a risk on stocking a full 100 count bottle for one prescription of 15 or 30 tablets,” said Barry Patel, Pharm.D., Galt CEO and Co-Founder. 

The 100-count bottle of Doral (Quazepam) will continue to be available and offers pharmacies value as demand for this insomnia treatment grows.

“This new package size will encourage both chain and independent pharmacists to stock Doral without the risk of excessive shelf inventory while this product continues to gain traction in the market,” said Taylor Froiland, Pharm.D., owner of Medmetrics Pharmacy, an independent pharmacy in Chandler, Arizona.

“We’ve built Galt as a pharmacist-centric company and are always thinking about how we can help independent pharmacies survive and thrive,” said Galt Co-Founder Galt Chairman Wade Smith, Pharm.D. “We have hundreds of partnerships with independent pharmacists across the U.S. We listened and learned that inventory control could make a positive impact on their businesses.”

Galt also adds value by teaming up with independent pharmacists to make its products accessible to patients regardless of insurance status through the Galt Direct Patient Assistance Program.

 

Important Safety Information (ISI)

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.1), Drug Interactions (7)]. 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.

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.

Benzodiazepine Withdrawal Syndrome: A withdrawal syndrome similar to that from alcohol (e.g., convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating) can occur following abrupt discontinuation of DORAL. Avoid abrupt discontinuation in at-risk patients of benzodiazepine withdrawal syndrome, particularly patients taking higher than recommended dose over an extended time, and the dose gradually tapered. Prescribers should monitor patients for tolerance, abuse, and dependence.

 

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.

Visit www.DoralRx.com for more details and full prescribing information.

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