Zaleplon, Oral

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KEY POINTS

• This medicine is taken by mouth to treat insomnia. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• 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, such as walking, cooking, or driving.
• This medicine may cause 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 pill

Generic and brand names: zaleplon, oral; Sonata

What is this medicine used for?

This medicine is taken by mouth for the short-term treatment (for 7 to 10 days) of insomnia (trouble falling asleep).

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 foods, preservatives, or dyes
• Depression, thoughts of suicide, or other mental health problem
• Liver or kidney problems
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Problems with alcohol or drug 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 your healthcare provider prescribes. Do not take more of this medicine or take it longer than prescribed. Long-term use may be habit-forming. Do not stop taking this medicine without your healthcare provider's approval if you have taken it every night for longer than 1 week.

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

Take this medicine on an empty stomach. Do not take this medicine with or right after a meal, because a high-fat or large meal may delay or reduce its effect.

Take this medicine only when you will be able to get a full night's sleep (7 to 8 hours) before you need to be alert. Take this medicine just before going to bed or after you have been in bed and have trouble falling asleep. Do not take more than 1 dose per night unless your healthcare provider approves.

This medicine acts quickly, usually in about 30 minutes.

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: slurred speech, hallucinations (seeing or hearing things that aren’t there), confusion, restlessness, nausea, drowsiness, slow breathing, lightheadedness, dizziness, fast heartbeat, fainting, 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

You may still be drowsy the day after you take this medicine. Do not drive or operate machinery 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.

Contact your healthcare provider if your insomnia does not improve in 7 to 10 days or if it gets worse. You may have more trouble falling asleep for 1 or 2 nights after you stop taking this medicine. Talk with your healthcare provider about this.

Adults over the age of 65 may be at greater risk for side effects from this medicine. 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.

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.): Hallucinations (seeing or hearing things that are not there); new or worsening depression, thoughts of suicide, unusual behavior or thoughts, unusual mood changes, severe confusion, memory problems, slowed breathing, trouble breathing, severe anxiety or nervousness, constant drowsiness, severe dizziness, vision problems, lack of coordination.

Other: Minor sleepiness or dizziness, headache, dry mouth, nausea, stomach pain, weakness, rash, sore muscles, abnormal dreams, pins and needles feelings on your skin, change in taste, changes in menstrual periods.

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), chlordiazepoxide, 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 itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), 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), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Qudexy, Topamax, Trokendi)
• 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)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), and mitotane (Lysodren)
• Cimetidine (Tagamet)
• Doxepin (Silenor)
• Flibanserin (Addyi)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Lumacaftor/ivacaftor (Orkambi)
• 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, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, temazepam (Restoril), triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• Pain medicines such as buprenorphine (Buprenex, Butrans), codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)

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.