Nova Quimica Zolpidem: Uses, Side Effects, Abuse, Addiction

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Nova Quimica Zolpidem is a brand of Zolpidem (Ambien) manufactured in Brazil by Nova Quimica. Zolpidem is a sedative, also called a hypnotic. It affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia). Nova Quimica Zolpidem is used to treat insomnia. The immediate-release forms are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep.

The extended-release form of zolpidem has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep. Zolpidem can help with difficulty falling asleep, frequent wake-ups during the night, or early morning awakenings. Zolpidem should usually not be taken for more than 7 to 10 consecutive days. It should only be used if disturbed sleep causes problems functioning during the day.

How should I use Nova Quimica Zolpidem?

The recommended adult dose of zolpidem is 5 mg for women and 5 mg to 10 mg for men. Women have higher levels of zolpidem in the blood than men when given the same dose. It also takes longer for women for the medication to be cleared from the body.

Nova Quimica Zolpidem should be taken just before bedtime when required to help with sleep disturbances. Zolpidem may be habit-forming and should be taken exactly as prescribed by your doctor. You should not typically use zolpidem for more than 7 to 10 consecutive days.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Do not take Nova Quimica Zolpidem with food or immediately after a meal. Food slows down the speed at which the medication works, increasing the length of time before the onset of sleep.

If you have been taking this medication regularly for an extended period of time, do not stop taking it suddenly without talking with your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you forget to take your tablet at bedtime, do not take it at any other time or in the middle of the night. Do not take this medication when a full night’s sleep (7 to 8 hours) is not possible (i.e., after waking in the middle of the night) or before you would need to be active and functional. Impaired judgment and memory lapses may occur in such situations. Your body needs time to process and get rid of the medication.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take Nova Quimica Zolpidem?

Do not take zolpidem if you:

• are allergic to zolpidem or any ingredients of this medication

• have a history or a family history of sleepwalking

• have myasthenia gravis

• have severe breathing difficulties

• have severely reduced liver function or liver disease

• have severe lung or respiratory disease, including sleep apnea

What are the side effects of Nova Quimica Zolpidem?

The following side effects have been reported by at least 1% of people taking Nova Quimica Zolpidem. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• diarrhea

• dizziness

• drowsiness

• excitement

• fatigue

• headache

• hyperactivity

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation

• anxiety

• behaviour changes (e.g., mood or mental changes, irritability, anger, aggression, violent behaviour)

• confusion (more common for seniors)

• daytime anxiety or restlessness

• drowsiness (severe)

• “drugged” feeling

• hallucinations (seeing or hearing things that aren’t there)

• memory problems

• signs of breathing problems (e.g., shortness of breath, troubled breathing, wheezing or tightness in chest, fast or irregular breathing)

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• sleepwalking

• withdrawal effects (e.g., abdominal cramps, vomiting, sweating, tremor, seizures)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• thoughts of self-harm or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication:

Alcohol use: The use of zolpidem after consuming alcohol increases the risk of severe side effects such as breathing difficulty and performing activities while not being aware or awake. Alcohol should not be consumed if you are taking zolpidem.

Allergic reaction: In rare cases, people have developed a serious allergic reaction to medications like Nova Quimica Zolpidem involving swelling of the tongue, glottis, or larynx. Some people have had shortness of breath, nausea, vomiting, or throat closing.

Other signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If you experience any of these symptoms after taking zolpidem, seek immediate medical attention.

Behaviour changes: This medication may cause agitated or aggressive behaviour. If you experience these symptoms or any other behaviour change while taking this medication, contact your doctor immediately.

Family members or caregivers of people who are taking this medication should contact the person’s doctor immediately if they notice unusual behaviour changes.

Breathing problems: Nova Quimica Zolpidem can suppress breathing. If you are at risk for breathing difficulties, such as asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Confusion: Nova Quimica Zolpidem affects mental efficiency (e.g., concentration, attention, and vigilance). The risk of confusion is greater for seniors and those with brain damage.

Dependence and withdrawal: Physical dependence, psychological dependence, and abuse have occurred with the use of Nova Quimica Zolpidem. If you have a history of past or current substance use problems, you may be at greater risk of developing abuse or addiction while taking this medication.

Withdrawal symptoms have been observed after stopping the medication suddenly (after having taken it regularly over a period of time). These symptoms include:

• abdominal cramps

• anxiety

• diarrhea

• fatigue

• flushing

• headache

• irritability

• memory impairment

• nausea

• nervousness

• restlessness

• seizures

• sleep problems such as rebound insomnia

• sweating

• tension

• tremors

• vomiting

If you have been taking this medication for longer than 10 days, discuss with your doctor the best way to stop Nova Quimica Zolpidem.

Depression: Medications used for sleep disturbances have been known to cause mood swings and symptoms of depression. Nova Quimica Zolpidem may worsen symptoms of depression, including thoughts of suicide or wanting to harm others.

If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Drowsiness/reduced alertness: Zolpidem can cause excessive daytime drowsiness and decreased mental alertness. Do not drive, operate machinery, or perform other dangerous tasks until you know how this medication affects you.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Memory disturbance: Although rare, amnesia of varying severity has been reported following normal doses of medications like Nova Quimica Zolpidem. This is an unpredictable effect of the medication. If you experience any memory problems while taking this medication, contact your doctor.

Performing activities while not fully awake: People taking Nova Quimica Zolpidem may perform activities such as sleepwalking, driving, preparing and eating food, and making phone calls while not fully awake and are unaware of their actions. The next morning, they may not remember what happened. This may be more likely to occur if you use alcohol or other sedative medications. If you discover this has happened to you, contact your doctor immediately.

Family members or caregivers of people who are taking this medication should contact the person’s doctor immediately if they notice any of these unusual behaviours.

Rebound insomnia: As with other medications used to aid in sleeping, you may experience a temporary return of your sleeping difficulties when zolpidem is stopped.

Pregnancy: The use of Nova Quimica Zolpidem during pregnancy has not been studied. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking Nova Quimica Zolpidem, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of zolpidem have not been established for use by children and adolescents less than 18 years of age.

Seniors: People over 65 years of age are more likely to experience dose-related side effects of zolpidem, such as drowsiness, dizziness, or impaired coordination. Lower doses of Nova Quimica Zolpidem are recommended for seniors.

What other drugs could interact with this medication?

There may be an interaction between Nova Quimica Zolpidem and any of the following:

• alcohol

• anticonvulsants (medications used to prevent seizures; e.g., phenytoin, valproic acid, carbamazepine, gabapentin)

• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)

• antipsychotic medications (e.g., olanzapine, quetiapine)

• azelastine

• “azole” antifungals (e.g., ketoconazole, itraconazole, voriconazole)

• barbiturates (e.g., butalbital, pentobarbital, phenobarbital)

• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)

• bosentan

• buprenorphine

• buspirone

• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)

• cannabis

• chloral hydrate

• ciprofloxacin

• conivaptan

• cyclosporine

• deferasirox

• dronedarone

• entacapone

• enzalutamide

• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)

• HIV protease inhibitors (e.g., darunavir, ritonavir, saquinavir)

• kava kava

• lithium

• macrolide antibiotics (e.g., clarithromycin, erythromycin)

• melatonin

• mirtazapine

• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)

• mifepristone

• mitotane

• modafinil

• nabilone

• narcotic or opioid medications (e.g., codeine, fentanyl, morphine, oxycodone)

• nefazodone

• pramipexole

• rifabutin

• rifampin

• ropinirole

• rotigotine

• St. John’s wort

• scopolamine

• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)

• siltuximab

• simeprevir

• tapentadol

• thalidomide

• tocilizumab

• tolcapone

• tramadol

• tricyclic antidepressants (e.g., amitriptyline, desipramine)

• tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)

• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also, tell them about any supplements you take. Since caffeine, alcohol, nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.