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Ambien CR (Generic Zolpidem)

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WARNING

Serious or even life-threatening sleep behaviours may be brought on by zolpidem. Some zolpidem users got out of bed and did things like drive their cars, cook and eat their meals, have sex, make phone calls, sleep walk, or engage in other activities while not fully awake. These people couldn’t recall what they had done when they awoke. If you’ve ever displayed atypical sleep behaviour while taking zolpidem, let your doctor know. Make sure your family or carer is aware of how dangerous these symptoms are and to call your doctor right away if they appear. If you discover that you drove or did anything else unexpected while you were sleeping, stop taking zolpidem and contact your doctor right once.

Why is this medication prescribed?

Insomnia can be treated with zolpidem (difficulty falling asleep or staying asleep). Sedative-hypnotics are a class of drugs that includes zolpidem. It functions by reducing brain activity to promote sleep.

How should this medicine be used?

For oral use, zolpidem is available as a tablet (Ambien) and an extended-release (long-acting) tablet (Ambien CR). Additionally, zolpidem is offered as an oral spray (Zolpimist), which is sprayed into the mouth over the tongue, as well as sublingual tablets (Edluar, Intermezzo), which are placed beneath the tongue. You should take the drug as needed, no more than once a day, right before bed if you’re using tablets, extended-release tablets, sublingual tablets (Edluar), or oral spray. If you’re using sublingual tablets (Intermezzo), you should only take the drug once during the course of the night if you wake up and find it difficult to fall back asleep. If zolpidem is not taken with a meal or right after eating, it will act more quickly. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Implement zolpidem exactly as advised.

After taking zolpidem, you’ll probably feel quite drowsy right away and continue to feel sleepy for a while. Plan to stay in bed for 7 to 8 hours after taking zolpidem oral spray, extended-release tablets, sublingual tablets (Edluar), or tablets. Only take zolpidem sublingual tablets (Intermezzo) if you can stay in bed for at least another 4 hours after you take them. If you won’t be able to sleep for the appropriate amount of time after taking zolpidem, do not take it. After taking zolpidem, you can feel drowsy and have memory, alertness, or coordination issues if you get up too quickly.

Do not split, chew, or crush the extended-release pills; instead, swallow them whole. If you have trouble swallowing pills, let your doctor or pharmacist know.

When you are prepared to take the sublingual tablet (Intermezzo), do not open the pouch containing the tablet. Remove the top paper layer from the sublingual tablet (Edluar) and press it through the foil to release it from the blister pack. Place the sublingual pill, from either brand, under your tongue, and wait for it to dissolve before taking it. Never take the tablet with water or in its whole.

Follow these instructions as well as those on the package label to use the oral spray:

  1. You must prime the pump before using zolpidem spray for the first time or if you haven’t used the spray bottle in 14 days.
  2. Align the arrows on the container’s base and cap. Pull the cap and base apart by squeezing the cap where the arrows are located. Remove the pump’s transparent protective cap.
  3. Hold the bottle upright to prime the pump. Aim to keep your face and other people’s faces away from the black spray opening. Your fingertip should press down on the pump, then you should let go and let it return to its starting position four more times. A fine spray ought to emerge from the container.
  4. To use the zolpidem spray, hold the bottle upright and place your tongue on top of the black spray aperture in your mouth. To ensure that a full dose of zolpidem is sprayed, thoroughly depress the pump.
  5. Allow the pump to revert to its initial position. After each usage, cover the pump at the top of the base with the clear protective cap if your doctor only ordered one spray of zolpidem. Use the second spray of zolpidem if your doctor has instructed you to take two sprays of the medication.
  6. Rotate the cap and base so that the arrows are not lined up before snapping the child-resistant cap back onto the base. This is done to make it more difficult for kids to use the spray mist bottle.

After you begin taking zolpidem, your sleep issues should start to improve within 7 to 10 days. If your sleep issues do not improve during this period or if they worsen at any point while you are receiving therapy, call your doctor.

Typically, zolpidem should only be used for brief periods of time. It’s possible that zolpidem won’t help you sleep as well as it did when you initially started taking it if you’ve been taking it for more than two weeks. The dangers of using zolpidem for two weeks or more should be discussed with your doctor.

The drug zolpidem may cause dependence. Never take zolpidem in excess of what your doctor has prescribed, either in terms of dosage or frequency or duration of use.

If you have been on zolpidem for more than two weeks, you should not stop taking it without first consulting your doctor. If you stop taking zolpidem abruptly, you could experience unpleasant emotions or mood swings as well as withdrawal symptoms like trembling, lightheadedness, stomach and muscle cramps, nausea, vomiting, sweating, flushing, fatigue, uncontrollable crying, nervousness, panic attacks, difficulty falling or staying asleep, uncontrollable shaking of a part of your body, and, very rarely, seizures.

On the first night after stopping zolpidem, you might have more trouble falling asleep or staying asleep than you did when you first started taking it. This is typical, and after one or two nights, it normally gets better on its own.

Whenever you refill your prescription for zolpidem, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089833.pdf).

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking zolpidem,

  • If you have an allergy to zolpidem, any other medications, or any of the substances in the zolpidem product you’re using, let your doctor and pharmacist know right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Make sure to mention any of the following: rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sleeping pills; and tranquillizers. Antidepressants (also known as “mood elevators”) include imipramine (Tofranil) and sertraline (Zoloft); chlorpromazine; itraconazole (Onmel, Sporanox); and ketoconazole (Nizo Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • On the same night, you shouldn’t take more than one sleeping medication. You shouldn’t take a zolpidem sublingual tablet (Intermezzo) or any other sleeping medication if you took a zolpidem product or another form of sleeping medication before going to bed and you wake up in the middle of the night.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your physician if you currently use or have previously used excessive amounts of street drugs, alcohol, or prescription medications. Tell your doctor if you suffer from or have ever experienced depression, mental illness, suicidal thoughts or attempts, heavy snoring, sleep apnea, other breathing issues or lung diseases like asthma, bronchitis, or emphysema, myasthenia gravis (a condition that causes weakness in specific muscles), kidney or liver disease, or any other health issues.
  • If you are expecting, especially if you are in the last few months of your pregnancy, planning to get pregnant, or breastfeeding, let your doctor know. Call your doctor if you become pregnant while taking zolpidem.
  • If you are 65 years of age or older, discuss the advantages and disadvantages of taking zolpidem with your doctor. Since zolpidem is less safe and less successful than alternative drugs that can be used to treat the same illness, older persons should often avoid taking it.
  • Inform your doctor or dentist that you are taking zolpidem if you are having surgery, including dental surgery.
  • You should be aware that zolpidem may make you drowsy, less mentally alert, take longer to react, impair coordination, and increase your risk of falling the day after taking it. If you get out of bed in the middle of the night, take extra precautions to prevent falling. Even if you feel fully awake the day after taking zolpidem, it’s possible that you won’t be able to drive or operate machinery. The day after taking an extended-release zolpidem medication, avoid using machinery or driving a car. The dangers of operating machinery or driving the day after taking any other zolpidem drugs should be discussed with your doctor.
  • Don’t consume alcohol while receiving zolpidem medication. The negative effects of zolpidem can be exacerbated by alcohol.
  • You should be aware that while taking this medicine, your behaviour and mental health may alter in unanticipated ways. It can be difficult to determine whether these alterations are brought on by zolpidem or by underlying physical or mental problems that you may already have or unexpectedly develop. If you develop any of the following symptoms, contact your doctor right away: aggressiveness, weird or unusually outgoing behaviour, hallucinations (seeing or hearing things that are not there), feeling as though you are outside of your body, memory issues, difficulty concentrating, any other deviations from your typical thoughts, emotions, or behaviour should be reported, including anxiety, easily becoming irritated, slower speech or movements, new or worsening depression, suicidal thoughts or attempts, bewilderment, and anxiousness. Make sure your family is aware of any potentially critical symptoms so they can contact the doctor on your behalf if you are unable to get help on your own.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

You take this medication as needed. If you will be able to stay in bed for the required number of hours after taking zolpidem, you may take it even if it is later than normal.

What side effects can this medication cause?

Zolpidem might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Drowsiness
  • Tiredness
  • Headache
  • Dizziness
  • Lightheadedness
  • “Drunk feeling”
  • Insecure walking
  • Trouble maintaining balance
  • Nausea
  • Constipation
  • Diarrhea
  • Gas
  • Heartburn
  • Stomach discomfort or agony
  • Alterations in appetite
  • Body part shaking that is uncontrollable
  • Hands, arms, feet, or legs that hurt, burn, are numb, or are tingly
  • Strange dreams
  • Tongue tingling, burning, or rashes (with sublingual tablets)
  • Dry mouth or throat
  • Ear ringing, discomfort, or itchiness
  • A reddened eye
  • Achy or cramping muscles
  • Neck, back, or joint pain
  • Extreme menstrual bleeding

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those detailed in the IMPORTANT WARNINGS or SPECIAL PRECAUTIONS sections:

  • Rash
  • Hives
  • Itching
  • Eye, face, lip, tongue, or throat swelling
  • A sensation of the throat closing
  • Breathing or swallowing challenges
  • Hoarseness
  • Breathing difficulty
  • Eyes or skin that are yellow
  • Light-colored stools
  • Nausea
  • Vomiting
  • Rapid heartbeat
  • Chest pain
  • Vision blurriness or other issues with vision

 

Other adverse effects of zolpidem could occur. If you have any strange side effects while taking this medicine, contact your doctor right once.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Away from excessive heat, light, and moisture, keep it at room temperature (not in the bathroom). No zolpidem oral spray should be frozen. Keep the oral spray container of zolpidem upright.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Drowsiness
  • Coma (loss of consciousness for a period of time)
  • Slowed breathing or heartbeat

What other information should I know?

Keep all of your doctor’s appointments.

No one else should take your medication. A controlled substance is zolpidem. Only a limited amount of refills are permitted for prescriptions; if you have any doubts, speak with your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Ambien®
  • Ambien® CR
  • Edluar®
  • Intermezzo®
  • Zolpimist®
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