Quazepam (Page 3 of 3)


QUAZEPAM contains quazepam, a trifluoroethyl benzodiazepine hypnotic agent, having the chemical name 7-chloro-5- (o-fluoro-phenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-2H -1,4-benzodiazepine-2-thione and the following structural formula:

QUAZEPAM Structural Formula

Quazepam has the empirical formula C17 H11 CIF4 N2 S, and a molecular weight of 386.8. It is a white crystalline compound, soluble in ethanol and insoluble in water. Each QUAZEPAM Tablet contains 15 mg of quazepam. The inactive ingredients for QUAZEPAM Tablets include cellulose, corn starch, FD&C Yellow No. 6 Al Lake, lactose, magnesium stearate, silicon dioxide, and sodium lauryl sulfate.


12.1 Mechanism of Action

Quazepam, like other central nervous system agents of the 1,4-benzodiazepine class, presumably exerts its effects by binding to stereo-specific receptors at several sites within the central nervous system (CNS). The exact mechanism of action is unknown.

12.3 Pharmacokinetics

Absorption: Quazepam is rapidly (absorption half-life of about 30 minutes) and well absorbed from the gastrointestinal tract. The peak plasma concentration of quazepam is approximately 20 ng/mL after a 15 mg dose and occurs at about 2 hours.

Metabolism: Quazepam, the active parent compound, is extensively metabolized in the liver; two of the plasma metabolites are 2-oxoquazepam and N-desalkyl-2-oxoquazepam. All three compounds show CNS depressant activity.

Distribution: The degree of plasma protein binding for quazepam and its two major metabolites is greater than 95%.

Elimination: Following administration of 14 C-quazepam, 31% of the dose appeared in the urine and 23% in the feces over five days; only trace amounts of unchanged drug were present in the urine.

The mean elimination half-life of quazepam and 2-oxoquazepam is 39 hours and that of N-desalkyl-2-oxoquazepam is 73 hours. Steady-state levels of quazepam and 2-oxoquazepam are attained by the seventh daily dose and that of N-desalkyl-2-oxoquazepam by the thirteenth daily dose.

Special Populations:

Geriatrics: The pharmacokinetics of quazepam and 2-oxoquazepam in geriatric subjects are comparable to those seen in young adults; as with desalkyl metabolites of other benzodiazepines, the elimination half-life of N-desalkyl-2-oxoquazepam in geriatric patients is about twice that of young adults.

12.4 Drug Interactions

Bupropion (a CYP2B6 substrate): Co-administration of a single dose of 150 mg Bupropion Hydrochloride XL with steady state quazepam did not significantly affect the AUC and Cmax of bupropion or its primary metabolite, hydroxybupropion.


13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility


Quazepam showed no evidence of carcinogenicity in oral carcinogenicity studies in mice and hamsters.


Quazepam was negative in the bacterial reverse mutation (Ames) assay and equivocal in the mouse lymphoma tk assay.

Impairment of Fertility

Reproduction studies in mice conducted with quazepam at doses equal to 60 and 180 times the human dose of 15 mg produced slight reductions in fertility rate. Similar reductions in fertility rate have been reported in mice dosed with other benzodiazepines, and is believed to be related to the sedative effects of these drugs at high doses.


The effectiveness of QUAZEPAM was established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of QUAZEPAM was established in chronic insomnia in a sleep laboratory (polysomnographic) study of 28 nights duration.

In the sleep laboratory study, QUAZEPAM significantly decreased sleep latency and total wake time, and significantly increased total sleep time and percent sleep time, for one or more nights. QUAZEPAM 15 mg was effective on the first night of administration. Sleep latency, total wake time and wake time after sleep onset were still decreased and percent sleep time was still increased for several nights after the drug was discontinued. Percent slow wave sleep was decreased, and REM sleep was essentially unchanged. No transient sleep disturbance, such as “rebound insomnia,” was observed after withdrawal of the drug in sleep laboratory studies in 12 patients using 15 mg doses.

In outpatient studies, QUAZEPAM Tablets improved all subjective measures of sleep including sleep latency, duration of sleep, number of awakenings, occurrence of early morning awakening, and sleep quality. Some effects were evident on the first night of administration of QUAZEPAM (sleep latency, number of awakenings, and duration of sleep).

A double-blind, controlled sleep laboratory study (N=30) in elderly patients compared the effects of quazepam 7.5 mg and 15 mg to that of placebo over a period of 7 days. Both the 7.5 mg and 15 mg doses appeared to be effective. Caution must be used in interpreting this data due to the small size of the study.


QUAZEPAM Tablets, 15 mg, functionally scored, capsule-shaped, light orange, slightly white speckled tablets, impressed with the product identification number 15 on one side of the tablet, and the product name (QUAZEPAM) on the other.

Bottle of 30 — 68788-9664-3

Bottle of 60 — 68788-9664-6

Bottle of 90 — 68788-9664-9

Store QUAZEPAM® Tablets at controlled room temperature 20°-25°C (68°-77°F).


See FDA-approved patient labeling (Medication Guide).

Inform patients about the benefits and risks of QUAZEPAM, stressing the importance of use as directed. Assist patients in understanding the Medication Guide and instruct them to read it with each prescription refill.

CNS depressant Effects and Next-Day Impairment

Tell patients that QUAZEPAM can cause next-day impairment, even in the absence of symptoms. Caution patients against driving or engaging in other hazardous activities or activities requiring complete mental alertness when using QUAZEPAM. Tell patients that daytime impairment may persist for several days following discontinuation of QUAZEPAM.


Instruct patients to contact you before stopping or decreasing the dose of QUAZEPAM, because withdrawal symptoms can occur.

Abnormal thinking and behavior change

Instruct patients that sedative hypnotics can cause abnormal thinking and behavior change, including “sleep-driving” and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients to call you immediately if they develop any of these symptoms.

Severe Allergic Reactions

Inform patients that severe allergic reactions can occur from QUAZEPAM. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if these occur.


Tell patients that QUAZEPAM can worsen depression, and to immediately report any suicidal thoughts.

Alcohol and other drugs

Ask patients about alcohol consumption, medicines they are taking now, and drugs they may be taking without a prescription. Advise patients that alcohol generally should not be used during treatment with QUAZEPAM.


Instruct patients to inform you if they are nursing or pregnant, or may become pregnant while taking QUAZEPAM.

Tolerance, Abuse, and Dependence

Tell patients not to increase the dose of QUAZEPAM on their own, and to inform you if they believe the drug “does not work”.

Manufactured for:
Questcor Pharmaceuticals, Inc.
Hayward, CA 94545 USA
phone (800) 411-3065
(510) 400-0700
fax (510) 400-0799

Manufactured by:
Meda Pharmaceuticals, Inc.
Somerset, NJ 08873-4120

Under license from Baker Norton Pharmaceuticals, Inc.

Printed in USA.
IN-1500-06 Rev:04/13


Tablets (C-IV)

Read the Medication Guide that comes with QUAZEPAM before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about QUAZEPAM?

QUAZEPAM may cause serious side effects that you may not know are happening to you. These side effects include:

  • sleepiness during the day
  • not thinking clearly
  • act strangely, confused, or upset
  • “sleep-walking” or doing other activities when you are asleep like:

º eating

º talking

º having sex

º driving a car

Call your healthcare provider right away if you find out that you have done any of the above activities after taking QUAZEPAM.


QUAZEPAM is a prescription medicine used to treat certain types of insomnia including difficulty falling asleep, waking up often during the night, or waking up early in the morning.

It is not known if QUAZEPAM is safe and effective in children.

QUAZEPAM is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep QUAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away QUAZEPAM may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take QUAZEPAM?

Do not take QUAZEPAM if you:

  • are allergic to quazepam or any of the ingredients in QUAZEPAM. See the end of this Medication Guide for a complete list of ingredients in QUAZEPAM.
  • have had an allergic reaction to other sleep medicines or sedatives such as benzodiazepines. Symptoms of a serious allergic reaction to quazepam can include:

º swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

º nausea and vomiting

º have sleep apnea, snoring, breathing or lung problems

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

What should I tell my healthcare provider before taking QUAZEPAM?

QUAZEPAM may not be right for you. Before taking QUAZEPAM, tell your healthcare provider about all of your health conditions, including if you:

  • have a history of depression, mental illness or, suicidal thoughts
  • have a history of drug or alcohol abuse or addiction
  • have lung disease or breathing problems
  • are pregnant or plan to become pregnant. It is not known if QUAZEPAM can harm your unborn baby.
  • are breastfeeding, or plan to breastfeed. QUAZEPAM can pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take QUAZEPAM.

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

Medicines can interact with each other, sometimes causing serious side effects. Do not take QUAZEPAM with other medicines that can make you sleepy unless your healthcare provider tells you to.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take QUAZEPAM?

  • See “What is the most important information I should know about QUAZEPAM?”
  • Take QUAZEPAM exactly as your healthcare providers tell you to take it.
  • Do not stop taking QUAZEPAM without talking to your healthcare provider, drug withdrawal symptoms can happen.
  • QUAZEPAM comes in 15 mg tablets. Your healthcare provider may start your QUAZEPAM dose at 7.5 mg which is half a tablet. Talk to your healthcare provider or pharmacist about your dose schedule.
  • You should not drink alcohol while you are taking QUAZEPAM.
  • Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
  • If you take too much QUAZEPAM or overdose, get emergency treatment right away.

What are the possible side effects of QUAZEPAM?

QUAZEPAM may cause serious side effects, including:

  • getting out of bed while not being fully awake and doing an activity that you do not know you are doing. See “What is the most important information I should know about QUAZEPAM?
  • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
  • memory loss
  • severe allergic reactions. Symptoms include swelling of the tongue or throat, and trouble breathing. Get emergency medical help right away if you have these symptoms after taking QUAZEPAM.

Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using QUAZEPAM.

Common side effects of QUAZEPAM include:

  • drowsiness
  • headache
  • feeling very tired
  • dizziness
  • dry mouth
  • upset stomach

After you stop taking a sleep medicine, you may have symptoms for the next 1 to 2 days such as:

  • trouble sleeping
  • nausea
  • flushing
  • lightheadedness
  • uncontrolled crying
  • vomiting
  • stomach cramps
  • panic attack
  • nervousness
  • stomach area pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of QUAZEPAM. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store QUAZEPAM?

  • Store at room temperature between 68°F to 77° F (20°C to 25°C).
  • Keep QUAZEPAM and all medicines out of the reach of children

General information about the safe and effective use of QUAZEPAM.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QUAZEPAM for a condition for which it was not prescribed. Do not share QUAZEPAM with other people, even if they have the same symptoms that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about QUAZEPAM. If you would like more information about QUAZEPAM, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about QUAZEPAM that is written for healthcare professionals.

If you would like more information, go to http://www.QUAZEPAMforsleep.com or call Questcor Pharmaceuticals at 1-800-411-3065QUAZEPAM.

What are the ingredients in QUAZEPAM?

Active Ingredient: quazepam

Inactive Ingredients: cellulose, corn starch, FD&C Yellow No. 6 Al Lake, lactose, magnesium stearate, silicon dioxide, and sodium lauryl sulfate.

Distributed by Questcor Pharmaceuticals, Inc.

Hayward, CA 94545 USA
This Medication Guide has been approved by the U.S. Food and Drug Administration.

(IS-1500-02 Rev. 04/13)

Repackaged by Preferred Pharmaceuticals, Inc.

Package Label – Principal Display Panel – 15mg Tablet

QUAZEPAM (quazepam tablets, USP)
15 mg Tablets
Provide a MEDICATION GUIDE each time this drug is dispensed to a patient. MEDICATION GUIDES are enclosed.
Rx only

Quazepam Tablets, USP 15mg CIV
(click image for full-size original)
quazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-9664(NDC:76218-0405)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color ORANGE (LIGHT) Score 2 pieces
Shape CAPSULE Size 12mm
Flavor Imprint Code 15;QUAZEPAM
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9664-3 30 TABLET in 1 BOTTLE None
2 NDC:68788-9664-6 60 TABLET in 1 BOTTLE None
3 NDC:68788-9664-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018708 08/15/2013
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-9664)

Revised: 08/2013 Preferred Pharmaceuticals, Inc.

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