Zolpidem Tartrate, Sublingual

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KEY POINTS

• This medicine is used under the tongue to treat the kind of insomnia in which you have trouble falling asleep. Use 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: sedative; sleeping aid

Generic and brand names: zolpidem tartrate, sublingual; Edluar

What is this medicine used for?

This medicine is used under the tongue to treat the kind of insomnia in which you have trouble falling asleep. This medicine is for short-term use only, usually 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 taking this medicine, tell your healthcare provider if you have ever had:

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

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

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 directed. Do not take more than one dose in 24 hours. Do not take more or take it for a longer time than directed by your healthcare provider. Taking too much may be habit-forming. Do not stop taking this medicine without your healthcare provider's approval if you have taken it for a long time. You may have to reduce your dosage gradually to avoid withdrawal symptoms. Talk with your healthcare provider about this.

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

Take this medicine just before going to bed because it works quickly to produce sleep. Do not take this medicine unless you will get 7 or 8 full hours of sleep after taking it because this medicine affects you for at least 7 hours.

Carefully remove the medicine from the blister pack one dose at a time. Peel off the top layer of paper and push the tablet through the foil. Do not use the medicine if the seal on the blister pack is broken, or if the blister holding the tablet is broken. Place the tablet under your tongue and let it dissolve. Do not take the tablet with water and do not swallow it whole. Take this medicine on an empty stomach. Taking this medicine with food or water will delay its effects.

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: drowsiness, confusion, shallow breathing, lightheadedness, fainting, vomiting, restlessness, slurred speech, trouble standing or walking, hallucinations (seeing or hearing things that aren’t there), coma.

What should I watch out for?

After taking this medicine, you may get up out of bed while not being fully awake and do things that you do not know you are doing, and will not remember the next morning. Contact your healthcare provider right away if you find out you have been:

• Sleep-walking
• Sleep-driving
• Making and eating food
• Talking on the phone
• Having sex

Do not drive or operate machinery the day after using this medicine unless you are fully alert.

Behavior changes may be caused by the medicine or by an illness present before the medicine was used. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Hallucinations
• Memory problems
• Worsening of depression
• Suicidal thoughts

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

Adults over the age of 65 and women may be at greater risk for side effects. Do NOT take more than the amount prescribed.

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

After you stop taking this medicine, you may have symptoms for 1 or 2 days such as trouble falling asleep, nausea, flushing, uncontrolled crying, nervousness, vomiting, and stomach pain. Talk with your healthcare provider about this.

This medicine is a controlled substance. 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.

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

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; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Depression or thoughts of suicide; hallucinations; sudden mood or behavior changes; memory problems; confusion; irregular or fast heartbeat; chest pain; trouble breathing or swallowing; severe drowsiness or dizziness; vision problems; worsening trouble sleeping.

Other: Muscle or joint pain, tiredness, lightheadedness, dizziness, daytime drowsiness, abnormal dreams, dry mouth, headache, nausea, vomiting, constipation, diarrhea, stomach pain, hiccups.

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), clonazepam (Klonopin), 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, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), loratadine (Alavert, Claritin), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), 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), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and nilotinib (Tasigna)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Doxepin (Silenor)
• Heart medicines such as diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), and tipranavir (Aptivus)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), meperidine (Demerol), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as aprepitant (Emend), prochlorperazine (Compro), and promethazine
• Other sleeping pills such as triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Paroxetine (Brisdelle, Paxil, Pexeva)

Do not drink alcohol unless your healthcare provider approves.

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

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.