Quazepam

You should not use quazepam if you have sleep apnea or a chronic breathing disorder.

Do not drink alcohol while taking quazepam or for several days after you stop taking this medicine.

Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity.

Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have hives, nausea and vomiting, snoring, difficult breathing, or swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking quazepam and talk with your doctor about another treatment for your sleep disorder.

You should not use quazepam if you are allergic to it, or if you have:

• sleep apnea (breathing stops during sleep) or a chronic breathing disorder; or

• an allergy to sleep medicine or to other benzodiazepines (such as alprazolam, diazepam, lorazepam, midazolam, Ativan, Valium, Tranxene, Versed, Xanax, and others).

To make sure quazepam is safe for you, tell your doctor if you have:

• breathing problems;

• a history of depression, mental illness, suicidal thoughts or behavior;

• a history of drug or alcohol addiction;

• liver or kidney disease; or

• if you use a narcotic (opioid) medication.

It is not known whether this medicine will harm an unborn baby. If you use quazepam while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Quazepam can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The sedative effects of quazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking quazepam.

Quazepam is not approved for use by anyone younger than 18 years old.

In the U.S.

• Doral

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypnotic

Pharmacologic Class: Benzodiazepine, Long Acting

Quazepam is used to treat insomnia (trouble in sleeping). quazepam is for short-term (usually 7 to 10 days) use only. Quazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

quazepam is available only with your doctor's prescription.

Take quazepam only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

quazepam should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take quazepam just before going to bed, when you are ready to go to sleep. quazepam works very quickly to put you to sleep.

Use quazepam only when you cannot sleep. You do not need to keep a regular dosage schedule for taking it. Do not use two doses at the same time.

Dosing

The dose of quazepam will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of quazepam. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For insomnia (trouble in sleeping):
    • Adults and older adults—At first, 7.5 milligrams (mg) (half-tablet) at bedtime. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of quazepam, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take quazepam. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert after you take this medicine. You may still feel sleepy the day after you take quazepam. Avoid these tasks or actions until you feel fully awake.
• This medicine may be habit-forming with long-term use.
• When sleep drugs are used nightly for more than a few weeks, they may not work as well to help sleep problems. This is known as tolerance. Only use sleep drugs for a short time. If sleep problems last, call the doctor.
• Do not take this medicine for longer than you were told by your doctor.
• If you have been taking quazepam for more than 10 days, talk with your doctor before stopping. You may want to slowly stop this medicine.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Avoid drinking alcohol while taking quazepam.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Some people have done certain tasks or actions while they were not fully awake like driving, making and eating food, and having sex. Most of the time, people do not remember doing these things. Tell your doctor if this happens to you.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine is not approved for use in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using quazepam while you are pregnant.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

5.1       CNS-Depressant Effects and Daytime Impairment 

Quazepam is a central nervous system (CNS) depressant and can impair daytime function in some patients even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of subjective symptoms, and may not be reliably detected by ordinary clinical exam (i.e. less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of Quazepam may develop, patients using Quazepam should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness.

Additive effects occur with concomitant use of other CNS depressants (e.g., other benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of Quazepam and concomitant CNS depressants should be considered. The potential for adverse drug interactions continues for several days following discontinuation of Quazepam, until serum levels of both active parent drug and psychoactive metabolites decline.

Use of Quazepam with other sedative-hypnotics is not recommended. Alcohol generally should not be used during treatment with Quazepam. The risk of next-day psychomotor impairment is increased if Quazepam is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if co-administered with other CNS depressants [see Dosage and Administration (2)].

5.2       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 Quazepam. The more severe withdrawal effects are usually limited to patients taking higher than recommended doses over an extended time. Abrupt discontinuation should be avoided in such patients, and the dose gradually tapered. Prescribers should monitor patients for tolerance, abuse, and dependence.

Milder withdrawal symptoms (e.g., dysphoria and insomnia) can occur following abrupt discontinuation of benzodiazepines taken at therapeutic levels for short periods [See Drug Abuse and Dependence (9)].

5.3       Need to Evaluate for Co-morbid Diagnoses 

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, 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. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs.

5.4       Severe Anaphylactic and Anaphylactoid Reactions 

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Quazepam. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.

Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Quazepam should not be rechallenged with the drug.

5.5       Abnormal Thinking and Behavior Changes 

Abnormal thinking and behavior changes have been reported in patients treated with sedative-hypnotics including Quazepam. Some of these changes include decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, and depersonalization. Visual and auditory hallucinations have also been reported. Amnesia, and other neuro-psychiatric symptoms may occur.

Paradoxical reactions such as stimulation, agitation, increased muscle spasticity, and sleep disturbances may occur unpredictably.

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake, with amnesia for the event) have been reported with use of sedative-hypnotics. These behaviors can occur with initial treatment or in patients previously tolerant of Quazepam or other sedative-hypnotics. Although these behaviors can occur with use at therapeutic doses, risk is increased by higher doses or concomitant use of alcohol or other CNS depressants. Due to risk to the patient and community, Quazepam should be discontinued if "sleep-driving" occurs.

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.

5.6       Worsening of Depression 

Benzodiazepines may worsen depression. Consequently, appropriate precautions (e.g., limiting the total prescription size and increased monitoring for suicidal ideation) should be considered.

Contact a poison control center for up-to-date information on the management of benzodiazepine overdose.

Manifestations of Quazepam overdose include somnolence, confusion, and coma. General supportive measures should be employed, along with immediate gastric lavage. Dialysis is of limited value. Flumazenil may be useful, but can contribute to the appearance of neurological symptoms including convulsions. Hypotension may be treated by appropriate medical intervention. Animal experiments suggest that forced diuresis or hemodialysis are of little value in treating Quazepam overdose. As with the management of intentional overdose with any drug, the possibility of multiple drug ingestion should be considered.

Dosing should be cautious; begin at lower end of dosing range (ie, 7.5 mg)

No dosage adjustment provided in manufacturer’s labeling.

Commonly reported side effects of quazepam include: drowsiness. Other side effects include: dizziness, vertigo, insomnia, confusion, and headache. See below for a comprehensive list of adverse effects.

Patient Advice:
-Advice patient of next-day impairment, even in the absence of symptoms; may persist for several days following discontinuation.