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Description

Generic Name

Zolpidem tartrate

Active Ingredient

Zolpidem tartrate

Chemical Name and Composition

Zolpidem tartrate is chemically described as N,N-dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide L-(+)-tartrate (2:1).

Zolpidem tartrate is a white to off-white crystalline powder. It is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of about 764.88 (as the tartrate salt).

Medication Classification

Zolpidem is a non-benzodiazepine sedative-hypnotic, sometimes called a "Z-drug." Although it is not a benzodiazepine, it works on the same target. It binds to gamma-aminobutyric acid (GABA) receptors in the brain, enhancing the calming effect of GABA. This action helps you fall asleep and, in some formulations, stay asleep.

Zolpidem is a Schedule IV (CIV) controlled substance under U.S. federal law.

Indication

Zolpidem is indicated for the short-term treatment of insomnia in adults.

• Immediate-release tablets, sublingual tablets (Edluar), and oral spray (Zolpimist) are used for insomnia marked by trouble falling asleep.
• Extended-release tablets (Ambien CR) are used for insomnia marked by trouble falling asleep, staying asleep, or both.
• Low-dose sublingual tablets (Intermezzo) are used only for middle-of-the-night waking followed by difficulty returning to sleep, when at least 4 hours of bedtime remain.

Dosage Forms and Available Strengths

• Dosage Forms:
• • Immediate-release oral tablets (Ambien)
  • Extended-release oral tablets (Ambien CR)
  • Sublingual tablets (Edluar and Intermezzo)
  • Oral spray (Zolpimist)
• Route of Administration: Oral or sublingual (under the tongue)
• Common Strengths:
• • Immediate-release tablets: 5 mg and 10 mg
  • Extended-release tablets: 6.25 mg and 12.5 mg
  • Sublingual tablets (Edluar): 5 mg and 10 mg
  • Sublingual tablets (Intermezzo): 1.75 mg and 3.5 mg
  • Oral spray (Zolpimist): 5 mg per spray

Formulations and strengths may vary by manufacturer. Confirm the exact product and strength on your label.

Inactive Ingredients

Inactive ingredients vary by dosage form and manufacturer. Immediate-release tablets may contain lactose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and colorants that differ by strength. Extended-release tablets, sublingual tablets, and oral spray contain their own release-controlling agents, flavoring, or spray components. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take zolpidem exactly as prescribed by your healthcare provider. Use the lowest effective dose. Your provider will set your dose based on the product, your sex, your age, and your overall health. Do not change your dose or take it longer than directed.

How to Take Zolpidem

• Take zolpidem right before bedtime, only when you are able to stay in bed for a full night of sleep (7 to 8 hours) before you need to be active again.
• For the low-dose sublingual product used for middle-of-the-night waking (Intermezzo), take it only when you have at least 4 hours of bedtime remaining.
• Take zolpidem only once per night. Do not take a second dose in the same night.
• Immediate-release and extended-release tablets: Swallow whole with water.
• Extended-release tablets (Ambien CR): Do not crush, split, or chew the tablet. Doing so can change how the medicine is released.
• Sublingual tablets (Edluar, Intermezzo): Place the tablet under your tongue and let it dissolve completely. Do not swallow it whole, and do not take it with water.
• Oral spray (Zolpimist): Prime the pump before first use as directed, then spray directly into the mouth over the tongue.
• Do not take more than prescribed, and do not take it more often than directed.

Gender-Based and Product-Specific Dosing

• Women often clear zolpidem from the body more slowly than men, which can raise next-day drug levels. Because of this, the recommended starting dose is often lower for women than for men.
• For example, the recommended immediate-release starting dose is 5 mg for women and either 5 mg or 10 mg for men. Extended-release starting doses follow a similar pattern (6.25 mg versus 6.25 mg or 12.5 mg).
• Your provider will select the exact dose and product for your situation.

Food Considerations

Take zolpidem on an empty stomach for the fastest effect. Taking it with or right after a meal can slow how quickly it starts to work. Avoid alcohol entirely while taking zolpidem, as the combination can cause dangerous drowsiness and slowed breathing.

Missed Dose Instructions

• Zolpidem is taken only at bedtime when needed, so a missed dose is often not a concern.
• Only take zolpidem when you can stay in bed for a full night of sleep (or the required remaining hours for the low-dose product).
• Do not take two doses in the same night, and do not double up to make up for a missed dose.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Store the oral spray upright and follow the product's specific instructions.
• Keep out of the reach of children.

Disposal

Because zolpidem is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, zolpidem is on the FDA flush list, meaning the FDA recommends flushing it down the toilet to prevent accidental exposure, especially to children and pets. Follow the disposal instructions on your product label or ask your pharmacist.

Special Instructions

Children: The safety and effectiveness of zolpidem have not been established in patients younger than 18 years of age. It is not recommended for use in children. Keep the medication out of the reach of children. If a child swallows this medication, seek emergency care immediately.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of zolpidem, including drowsiness, dizziness, confusion, and unsteadiness, which can raise the risk of falls. A lower dose is recommended, such as 5 mg for the immediate-release form or 6.25 mg for the extended-release form. Take extra care when getting up during the night.

Patients with Liver Problems: Use with caution. Zolpidem is broken down mainly by the liver, so impaired liver function can increase drug levels and prolong effects. A lower dose is recommended for patients with mild to moderate liver problems, and the medication is not recommended for patients with severe liver problems.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, trouble waking the patient, unusual behavior during sleep, or new or worsening mood changes, and seek care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking zolpidem suddenly after regular or prolonged use. Abrupt discontinuation can cause withdrawal symptoms.
• If you and your provider decide to stop treatment, the dose may be reduced gradually using a plan set by your provider.
• Withdrawal symptoms may include unusual sweating, flushing, stomach cramps, nausea, vomiting, tiredness, nervousness, panic attacks, uncontrolled crying, shakiness, and, in rare cases, seizures.
• Rebound insomnia, where sleep problems return worse than before, may occur for a night or two after stopping. This usually improves on its own.
• Tell your provider if withdrawal symptoms occur so your plan can be adjusted.

Overdose Warning

An overdose of zolpidem can be serious and may be fatal, especially when combined with opioids, alcohol, or other central nervous system (CNS) depressants. Symptoms of overdose may include:

• Extreme drowsiness or difficulty staying awake
• Confusion
• Slowed or shallow breathing
• Loss of coordination or unsteadiness
• Very low blood pressure
• Loss of consciousness or coma

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. A medicine called flumazenil may be used in some cases to reverse the sedative effects. Treatment otherwise focuses on supportive care.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking zolpidem and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Complex sleep behaviors: Doing activities while not fully awake, such as sleep-walking, sleep-driving, preparing or eating food, making phone calls, or having sex, with no memory of the event. These behaviors can cause serious injury or death. Stop taking zolpidem and tell your provider if this happens even once.
• Respiratory depression: Slow, shallow, or difficult breathing, or extreme sleepiness, especially when combined with opioids or other CNS depressants.
• Severe allergic reactions (including angioedema and anaphylaxis): Swelling of the face, lips, tongue, or throat; trouble breathing or swallowing; hives; or a severe rash. These can be life-threatening and may occur after the first dose or later.
• Next-day impairment: Reduced alertness, drowsiness, and slowed thinking or coordination the day after taking zolpidem, which can affect driving and other activities, even if you feel fully awake.
• Suicidal thoughts or worsening depression: New or worsening depression, or thoughts of harming yourself.
• Memory loss (amnesia): Trouble remembering events that happened after taking the medication.
• Abnormal thinking or behavior changes: Confusion, agitation, hallucinations, or feeling detached from reality.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Drowsiness or sleepiness
• Dizziness or lightheadedness
• Headache
• Nausea
• Diarrhea
• Dry mouth
• Feeling groggy or "drugged" the next day
• Muscle aches

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

Conditions to Disclose to Your Healthcare Provider

Before taking zolpidem, tell your healthcare provider if you have or have had any of the following:

• A history of complex sleep behaviors, such as sleep-walking or sleep-driving, while taking a sleep medicine
• Breathing problems, such as chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea
• Liver or kidney problems
• Depression, mood problems, or thoughts of suicide
• A history of unusual behavior or mental health conditions
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Myasthenia gravis or other muscle weakness conditions
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take zolpidem if you:

• Have previously experienced complex sleep behaviors, such as sleep-walking, sleep-driving, or other activities while not fully awake, after taking zolpidem
• Have a known hypersensitivity to zolpidem or any component of the formulation. Serious reactions, including angioedema and anaphylaxis, have been reported.

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Because zolpidem is processed mainly by the CYP3A4 liver enzyme, many drugs can affect its levels. Key interactions include:

• Opioids: Combining zolpidem with opioids increases the risk of severe drowsiness, respiratory depression, coma, and death.
• Other CNS depressants: Sedatives, tranquilizers, other sleep medicines, muscle relaxants, certain antidepressants, antihistamines, and antipsychotics can add to drowsiness and breathing problems. A dose reduction may be needed.
• Alcohol: Drinking alcohol while taking zolpidem can dangerously increase sedation and the risk of slowed breathing. Avoid alcohol entirely.
• CYP3A4 inhibitors: Drugs such as certain antifungals (for example, ketoconazole, itraconazole), macrolide antibiotics, and some HIV medications may increase zolpidem levels and the risk of side effects and next-day impairment.
• CYP3A4 inducers: Drugs such as rifampin, carbamazepine, and St. John's wort may reduce zolpidem's effectiveness.
• Certain antidepressants: Medicines such as sertraline or imipramine may increase drowsiness or affect drug levels.
• Other sedating medicines: Any medicine that causes drowsiness may increase the sedative effects of zolpidem.

Monitoring Requirements

Your healthcare provider may monitor:

• Your response to treatment and whether your sleep improves
• Reports of complex sleep behaviors
• Signs of excessive sedation, next-day impairment, or respiratory depression, especially with other CNS depressants
• New or worsening mood, behavior, or mental health changes, including thoughts of self-harm
• Signs of tolerance, dependence, or misuse
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Zolpidem is a Schedule IV controlled substance.

• Although zolpidem is not a benzodiazepine, it can be misused and may be a target for people who abuse prescription medicines. The risk may be higher in people with a history of substance abuse.
• Physical dependence and tolerance can develop with continued use, particularly at higher-than-prescribed doses or with prolonged use. Physical dependence means you should not stop suddenly.
• Tolerance may develop, meaning the medication may become less effective over time. Do not increase your dose on your own.
• Do not sell or give away zolpidem. Doing so may harm others and is against the law.
• Misusing this medication can cause overdose and death, especially when combined with other substances.

Long-Term Use Considerations

• Zolpidem is intended for short-term use. The safety and effectiveness of long-term use have not been fully established.
• If your insomnia does not improve within 7 to 10 days, or worsens, tell your provider. This may signal an underlying condition that needs different treatment.
• Physical dependence and tolerance may develop with continued use. Any decision to stop treatment after prolonged use should involve a gradual, supervised taper.
• Do not take zolpidem for longer than prescribed without discussing it with your provider.

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Patient Counseling Information

Safe Medication Use

• Take zolpidem exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Take it only right before bedtime and only when you can stay in bed for a full 7 to 8 hours (or at least 4 hours for the low-dose middle-of-the-night product).
• Take only one dose per night. Never take a second dose in the same night.
• Do not crush, split, or chew extended-release tablets. Let sublingual tablets dissolve fully under the tongue.
• Do not stop taking zolpidem suddenly after regular use. Talk to your healthcare provider about a safe plan to stop.
• Do not share zolpidem with anyone else. Sharing is dangerous and against the law.
• Keep zolpidem in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Complex sleep behaviors: Stop taking zolpidem and tell your provider right away if you learn you have done activities such as driving, eating, walking, or making calls while not fully awake, with no memory of it. Do not restart zolpidem if this happens.
• Next-day driving impairment: Zolpidem can reduce your alertness and slow your reaction time the morning after you take it, even if you feel fully awake. Do not drive or do other activities that require full alertness until you know how the medicine affects you, and wait a full night's sleep before driving.
• Alcohol: Do not drink alcohol while taking zolpidem. Alcohol adds to the sedative effect and can be dangerous.
• Opioids and CNS depressants: Do not use these with zolpidem unless directed by your provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Mental health: Tell your provider about any new or worsening depression, unusual behavior, or thoughts of self-harm.
• Pregnancy: Tell your provider if you are pregnant or plan to become pregnant. Using zolpidem late in pregnancy may cause sedation or breathing problems in the newborn.
• Breastfeeding: Zolpidem can pass into breast milk and may affect a nursing baby. Talk to your provider before breastfeeding while taking zolpidem.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Learn you have done activities while asleep or not fully awake, such as sleep-driving or sleep-walking
• Have slow, shallow, or difficult breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Have a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, hives, or trouble breathing
• Develop new or worsening depression, unusual behavior, or thoughts of harming yourself
• Notice memory problems, confusion, hallucinations, or agitation
• Find that your insomnia does not improve or gets worse after 7 to 10 days
• Experience withdrawal symptoms after reducing or stopping the medication
• Have any symptom that concerns you or does not go away