Uses

Zoldem (zolpidem tartrate) is a type of drug known as a sedative or hypnotic. Zoldem is a non-benzodiazepine sedative-hypnotic that works by binding to GABA receptors. This decreases the time it takes to fall asleep and helps you stay asleep longer, resulting in better quality sleep. It also has some anticonvulsant and muscle relaxing effects, but to a lesser extent than benzodiazepines such as diazepam (Valium).

Zoldem is used to treat the following:

Insomnia (short-term treatment)
Difficulty initiating sleep

How should I take Zoldem?

Zoldem is available as an oral film-coated tablet. It should be administered without food. The effect of the drug may be slowed by ingestion with or immediately after a meal. It acts rapidly and therefore should be taken immediately before bedtime.

Zoldipem must be initiated with lowest recommended dose and used for the shortest possible time. Doses should be individualized.

How do I store Zoldem?

This drug should be stored at room temperature (<30°C). Always check the label before using this product. For safety, keep out of the reach of children and pets.

Do not use if the printed expiration date has passed, the product seal has been broken, or the product has changed in color, odor, or consistency.

Do not dispose of this product by pouring it down the drain, toilet, or into the environment. Ask your pharmacist regarding the proper way and location of disposal.

Precautions & Warnings

Because Zoldem is a sedative-hypnotic, it has CNS depressant effects. This effect is amplified when Zoldem is taken together with other drugs and substances that depress the CNS such as benzodiazepines, opioids, tricyclic antidepressants, antihistamines, and alcohol.

Next-day impairment may occur when the dose of Zoldem is taken with less than a full night of sleep remaining or together with any of the previously mentioned drugs or alcohol. Avoid driving or operating machinery after taking Zoldem, especially if you still feel drowsy after sleeping.

Zoldem may also alter your normal behavior and ability to think and remember. You may feel or act more aggressive, extroverted, and agitated. Sleepwalking or somnambulism may also occur after taking Zoldem. This is not limited to walking and includes complex behavior such as driving, preparing food, making phone calls, having sex, and other activities. Amnesia and anxiety may also occur.

If your insomnia is not improved or worsens after 7 to 10 days of treatment, this may indicate underlying, unaddressed psychiatric illnesses that should be evaluated by a professional. Mental illnesses such as depression, drug dependence, and paradoxical reactions may warrant discontinuation or substitution of Zoldem.

Before using this medication, inform your doctor if:

You have ever had an allergic reaction to Zoldem.
You have a history of allergy to other medications, food, or other substances.
You are taking other medications, especially other CNS depressants.
You have underlying health condition such as:
- Depression
- Anxiety disorder
- Substance dependency or addiction
- Sleep apnea
- Myasthenia gravis

Is it safe during pregnancy or breastfeeding?

Zoldem is a pregnancy category C drug. There are no adequate and well-controlled studies using Zoldem in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as determined by your doctor.

Traces of Zoldem passes into breast milk and is not recommended while lactating and breastfeeding. This drug should be used while breastfeeding only if the potential benefit justifies the potential risk to the child, as determined by your doctor.

Side Effects

All drugs have the potential to elicit side effects even with normal use. Many side effects are dose-related and will resolve when it is adjusted or at the end of therapy.

Potential side effects while using this drug include:

Drowsiness
Dizziness
Insomnia
Agitation, irritability
Nervousness
Hot flashes
Sweating
Increased risk of infection
Chest pain
Muscle weakness
Joint pain
Edema
Weight loss
Increased appetite
Impotence or decreased libido
Syncope or fainting
Hypo- or hypertension
Arrhythmias
Phlebitis
Diarrhea, constipation, or vomiting
Dry mouth
Thirst
Abnormal liver function
Urinary incontinence
Difficulty or painful urination
Rash
Photosensitivity

You may experience some, none, or other side effects not mentioned above. If you experience serious adverse reactions, you must stop taking the drug immediately. If you have any concerns about a side effect or it becomes bothersome, consult your doctor or pharmacist.

Interactions

This drug may interact with other medications. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist.

Known drugs and their interactions with medication include:

Imipramine
- Increased symptoms of CNS depression

Chlorpromazine
- Increased symptoms of CNS depression
Fluoxetine
- Prolonged half-life of zolpidem with continuous use
Sertraline
- Increased symptoms of CNS depression and possibility of visual hallucinations
Rifampicin
- Decreased concentration and effects of zolpidem
Ketoconazole, itraconazole
- Increased and prolonged concentration and effects of zolpidem
Ritonavir
- Increased risk of CNS and respiratory depression

If you experience an adverse drug interaction, stop taking this drug and continue taking your other medication. Inform your doctor immediately to reevaluate your treatment plan. Your dose may need to be adjusted, substituted with another drug, or discontinue using the drug.

Does food or alcohol interact with Zoldem?

It is best to take this drug on an empty stomach. Avoid taking supplements or food that contain St. John’s wort or grapefruit juice. Do not take Zoldem with alcohol as it may potentiate the effects of drowsiness and CNS depression.

Inform your doctor or pharmacist if you have any concerns regarding food-drug interactions.

What health conditions may interact with Zoldem?

This drug should be taken with caution if you have any of the following conditions or risk factors:

Hypersensitivity to zolpidem or other ingredients in the formulation
Obstructive sleep apnea
Myasthenia gravis
Severe hepatic insufficiency
Acute and/or severe respiratory depression
History of drug, alcohol, or substance abuse
Extremes of age (children or elderly)

Inform your doctor or pharmacist if you have any concerns regarding specific health conditions.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult your doctor or pharmacist before using Zoldem.

What is the dose of Zoldem for an adult?

For treating insomnia

Adults <65 years old:
- Women: Take 5 mg once a day immediately before bedtime with at least 7 to 8 hours remaining before you plan to wake up.
- Men: Take 5 to 10 mg once a day immediately before bedtime with at least 7 to 8 hours remaining before you plan to wake up.
- If doses of 5 mg are not effective, it can be increased to 10 mg.
Elderly (65 years and above) and/or hepatically impaired patients:
- Take 5 mg once a day immediately before bedtime.

What is the dose of Zoldem for a child?

Zoldem is not recommended for use in children under 18 years old. Consult your child’s doctor or a pharmacist for alternatives and more information.

How is Zoldem available?

This drug is available in the following dosage forms and strengths:

Zoldem (zolpidem tartrate) 10 mg film-coated tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of this drug, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

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Zoldem