Quazepam, Oral

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KEY POINTS

• This medicine is taken by mouth to treat insomnia. Take it exactly as directed.
• This medicine may cause walking or driving in your sleep, amnesia, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: benzodiazepine; sedative

Generic and brand names: quazepam, oral; Doral

What is this medicine used for?

This medicine is taken by mouth to treat insomnia (trouble falling asleep, frequent awakening during the night, and early morning awakening). It can be used for insomnia, poor sleeping habits, or medical conditions in which you need restful sleep. This medicine is usually for short-term use only (2 weeks or less). Longer-term use must be evaluated by your healthcare provider.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you take this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Anxiety, depression, or thoughts of suicide
• Liver or kidney disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Problems with alcohol or drug abuse

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. It works very quickly and is usually taken as needed at bedtime. Take this medicine only when you can get a full night of sleep (7 to 8 hours) before you need to be alert.

This medicine should be used for a short period, such as 7 to 10 days. Do not take more of it or take it longer than prescribed because it may be habit-forming. Do not increase the dosage on your own. Do not stop taking this medicine without consulting your healthcare provider. You need to reduce your dosage gradually. Stopping too quickly may cause withdrawal symptoms, which may include seizures.

Check with your healthcare provider before using this medicine in children under age 18.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: extreme drowsiness, confusion, muscle weakness, trouble walking, slurred speech, tremors, slow heartbeat, shallow breathing, lightheadedness, fainting, coma.

What should I watch out for?

This medicine may cause memory loss or amnesia. You may not know what you are doing for several hours after taking the medicine, including walking or driving in your sleep. If you have memory problems while taking this medicine, contact your healthcare provider right away.

This medicine may make you drowsy or dizzy the day after you take it. Do not drive or operate machinery unless you are fully alert.

This medicine may make you excited rather than drowsy. If this happens, ask your healthcare provider what to do.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

When you stop taking this medicine after you have taken it for a week or two, you may have disturbed sleep for the first night or two. You may also have withdrawal symptoms. Reducing your dosage gradually may lessen these problems. Follow your healthcare provider's instructions exactly.

Contact your provider if your insomnia does not improve in 7 to 10 days or if it gets worse.

If taken for a long time, this medicine may become less effective. Talk with your healthcare provider about this.

Contact your provider right away if you or your family notice:

• More outgoing, anxious, or aggressive behavior than normal
• Mood changes
• New or worsening depression
• New or increased thoughts of suicide

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

This medicine is a controlled substance and may be habit forming. It is illegal for you to give it to anyone else.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing, swelling of your lips, tongue or throat).

Serious (Report these to your healthcare provider right away.): irregular, fast or slow heartbeat; fainting or lightheadedness; depression; thoughts of suicide; memory problems; unusual excitement; sudden mood or behavior changes; hallucinations (seeing, hearing, or feeling things that aren't there); severe confusion; yellowing of the skin or eyes; dark urine or trouble urinating; trouble walking; slurred speech; blurred vision; muscle movement or twitching that you can't control; seizures.

Other: Headache, dizziness, drowsiness, tiredness, unusual dreams, heartburn, constipation, diarrhea, nausea, vomiting, dry mouth, sweating, mild rash, mild itching, weakness, appetite changes.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), levomilnacipran (Fetzima), nefazodone, nortriptyline (Pamelor), protriptyline (Vivactil), sertraline (Zoloft), trazodone, trimipramine (Surmontil), venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as brompheniramine, chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), dexchlorpheniramine, and diphenhydramine (Benadryl)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), loxapine (Loxitane), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ezogabine (Potiga), felbamate (Felbatol), lacosamide (Vimpat), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), perampanel (Fycompa), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), and mitotane (Lysodren)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Doxepin (Silenor)
• Flibanserin (Addyi)
• Heart medicines such as diltiazem (Cardizem, Cartia, Tiazac) and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Levodopa/carbidopa (Duopa, Rytary, Sinemet)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Mifepristone (Korlym, Mifeprex)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, melatonin, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxymorphone (Opana), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Scopolamine (Transderm Scop)
• Sleeping pills such as eszopiclone (Lunesta), ramelteon (Rozerem), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Theophylline

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.