Zolpidem

Boxed warning

Zolpidem has a boxed warning issued by the US Food and Drug Administration (FDA).

Complex sleep behaviors, while rare, can be serious and even fatal. These behaviors include ​​sleepwalking, sleep driving, and other activities that occur while you’re asleep under the effects of zolpidem. You might experience these behaviors after one dose, with or without alcohol or other central nervous system depressants like anxiety medication.¹

People using zolpidem who experience these complex sleep behaviors or engage in activities with no memory of performing them should stop taking the medicine and speak to their doctor.

Insomnia medications can cause impairment while driving or performing activities that require full alertness.

What is zolpidem?

Zolpidem belongs to a class of drugs called non-benzodiazepine sedative-hypnotics. It’s one of the most widely used medications for treating insomnia.

What You Need To Know About Insomnia

The medication improves sleep by boosting a chemical in the brain known as gamma-aminobutyric acid (GABA). GABA blocks some neurotransmitters that send signals to the brain, providing a calming effect and inducing sleep.

Zolpidem is regulated as a class C IV controlled substance.²

What is zolpidem used to treat?

Zolpidem was approved by the FDA for the short-term treatment of insomnia in adults. It treats insomnia by slowing nervous system activity.

Insomnia is a common disorder that makes it difficult for people to fall or stay asleep. The length of sleep needed for maximum energy restoration and cell rejuvenation varies from person to person, but the recommended duration of sleep is 7–8 hours per night.

The immediate-release form of the drug is best for people who have trouble falling asleep. The extended-release form of zolpidem can help if you have difficulty maintaining good sleep throughout the night.³

The drug has been studied and used off label for the treatment of dystonia and other neurologic disorders, but these are not approved uses.⁴ ⁵

The drug has not been approved for use in children.

Dosage forms and strengths

Zolpidem is available in different types of tablets and an oral spray. You can only obtain the drug with a prescription.

The oral tablet comes in three forms: sublingual (dissolves under your tongue), extended-release (releases the drug into the body slowly), and immediate-release (the drug is instantly released into your body).

Here are the dosage forms and strengths:

• Tablets (generic, Ambien): 5mg, 10mg

• Extended-release tablets (generic, Ambien CR): 6.25mg, 12.5mg

• Sublingual tablets

• Generic, Intermezzo: 1.75mg, 3.5mg

• Edluar: 5mg, 10mg

• Spray (Zolpimist): 5mg per actuation

Zolpidem dosing varies between males and females. It also depends on the timing of your sleep disturbance.

Always follow your prescriber’s recommended dosing schedule, and don’t take more than your prescribed dose.

How do you take zolpidem?

Take zolpidem immediately before bed with an expected 7–8-hour timeframe for sleep. If you don’t have the recommended amount of sleep, you might experience drowsiness and reduced alertness. These reactions increase in severity if you take zolpidem with alcohol or other central nervous system depressants, like anxiety medication.⁶

The drug might impair your motor skills, affect your vision, and prolong your reaction times. Bear this in mind if you plan to drive a vehicle or operate machinery. You are advised to wait until you regain full alertness before engaging in activities of this nature. Completing the recommended 7–8 hours of sleep reduces these risks.

Don’t crush or chew zolpidem. The regular tablet form should be swallowed whole. Don’t take the sublingual tablet out of its package until it’s time to take the dose. Then, you should hold it under your tongue until it dissolves. The spray formulation should be sprayed into your mouth over the tongue.

Zolpidem will work slower than usual if you take it after or with a meal. Remember, you must not take zolpidem if you have consumed alcohol.⁷

Seeing results

Zolpidem is a fast-acting sleep medication. You should expect to feel its effects in as little as one hour. The immediate-release form wears off quickly, so it may help you fall asleep faster, but it won’t necessarily help you stay asleep for longer.

The drug is generally prescribed for approximately four weeks. If you use it for longer than the recommended time period, you might become dependent on it and your insomnia symptoms may return.⁸

Who should not take zolpidem?

Zolpidem is not approved for use in children, so it shouldn’t be prescribed for patients younger than 18 years of age.

The medication may not be suitable for everyone. Consult with your doctor before starting this medication. The following factors might mean zolpidem is an unsuitable drug for you:⁹

• Previous allergic reaction to a similar medication

• History of a complex sleep behavior (such as sleepwalking) after taking sleep aids

• History of depression, suicidal thoughts or behavior, or other mental illness

• Sleep apnea or heavy snoring

• Lung disease, asthma, or other breathing problems

• Kidney or liver disease

• Myasthenia gravis

• History of addiction or current alcohol or drug use

• Frequently working after less than 7–8 hours of sleep, particularly in a hazardous job or one that requires full alertness

Potential side effects of zolpidem

Insomnia medications like zolpidem cause side effects in some people. Consult your doctor if you experience symptoms that don’t improve with regular use.¹⁰

Get immediate medical attention for any severe adverse effects.

Common side effects

The most common side effects you can expect to experience after taking zolpidem include any of the following:

• Palpitations (irregular or abnormally fast heart rate)

• Lightheadedness, dizziness

• Headache

• Drowsiness

• Chest pain

• Dry mouth

• Muscle pain

• Diarrhea or constipation

• Skin rash

• Flu-like symptoms

If these symptoms are mild, they will likely go away on their own within a few days or weeks. Ask your doctor for further instructions if they don’t improve.

Serious side effects

Zolpidem can sometimes cause severe adverse effects, such as:

• Allergic reactions, like severe rash, swelling of the face or tongue, and trouble breathing

• Worsening or new depression symptoms, like a lack of energy, excessive weight gain, feelings of worthlessness, and suicidal thoughts

• Engaging in activities while not fully awake, like sleepwalking, preparing meals and eating, having sex, or driving and having no memory of them

• Abnormal behaviors or thoughts, such as hallucinations and agitation

• Troubled, slow, or shallow breathing

• Amnesia and other memory problems

• Vision changes

The list includes some side effects that may occur while using zolpidem, but it doesn’t include all possible adverse effects. Consult with your doctor if you notice any abnormal symptoms after using the medication.

Overdose

It’s possible to take an overdose of zolpidem. Zolpidem toxicity can cause severe organ damage and death.

If you suspect you or someone else has taken too much of this drug, seek immediate help by calling 911 or heading to the nearest emergency department.

Possible signs of zolpidem overdose include any of the following:

• Drowsiness

• Slowed breathing and heartbeat

• Loss of consciousness

• Coma

After calling for help, you can provide immediate first aid by:

• Ensuring the person is breathing by listening and removing tight clothing around the neck and waist

• Checking for any signs of discoloration (blue or purplish hue) on the lips or fingernails

• Making sure their airway is clear

Do not attempt to induce vomiting, as it may worsen their situation.

Allergy information

Zolpidem may cause a severe allergic reaction. If this happens, stop using the medication immediately and seek help.

Some notable signs of an allergic reaction to zolpidem include any of the following:

• Hives, itchy skin

• Severe rash with peeling skin

• Swelling on the face, lips, tongue, and neck

• Difficulty breathing or swallowing

• Wheezing

• Vomiting

• Loss of consciousness

Long-term use

Zolpidem is labeled for short-term use as the body may become dependent on the drug. Long-term use of zolpidem may lead to:¹¹

• Withdrawal after discontinuation

• Misuse with increased dosage

• Illegal procurement, including forged prescriptions or street purchases

See a doctor to know if you can continue using the drug past the recommended time frame.

Pregnancy category

Zolpidem was designated by the FDA as a pregnancy category C drug. In category C, animal reproductive studies demonstrate adverse risks to the fetus. However, there is no conclusive evidence about effects on the human fetus due to insufficient research.¹²

Zolpidem may be prescribed during pregnancy if the benefits outweigh the potential risks. 

Zolpidem and pregnancy

If you’re pregnant or plan to get pregnant, talk with your doctor before using zolpidem. If you get pregnant while taking zolpidem, contact your doctor immediately.

Women who use zolpidem in their third trimester may deliver newborns with sedation, low tone, and respiratory depression.¹³

Zolpidem and breastfeeding

Zolpidem is present in the breast milk of mothers who take the drug. It may cause side effects in the breastfeeding infant. The medication is passed into the breast milk in minimal amounts and is only traceable for up to three hours after taking it. Therefore, older babies who are not breastfeeding at night would not likely be affected.¹⁴ ¹⁵

Additionally, using zolpidem may interfere with your ability to care for your infant at night. You will need to consider this when weighing the medication’s risks and benefits.

Missed doses

Always remember to follow your doctor’s instructions for taking zolpidem. In case you miss a dose of the immediate-release or extended-release tablet, take it as soon as you remember. However, you should only do so if there are 7–8 hours before you need to wake up.

Taking low-dose sublingual tablets is not advisable if you have less than four hours to sleep.

Drug interactions

Zolpidem can interact negatively with other non-prescription, prescription, and herbal medicines. Taking zolpidem simultaneously with any of the following is not recommended:

• Pain medicines like hydrocodone (Vicodin, Lortab), morphine, and oliceridine (Olinvyk)

• Migraine medications, such as butalbital (in Fioricet, Zebutal) and sumatriptan (Imitrex)

• Sedatives or muscle relaxants, such as flurazepam (Dalmane), midazolam (Versed), and temazepam (Restoril)

• Other sleeping medicines, such as daridorexant (Quvivq), doxylamine (Unisom), eszopiclone (Lunesta), lemborexant (Dayvigo), ramelteon (Rozerem), suvorexant (Belsomra), zaleplon (Sonata), and tasimelteon (Hetlioz)

• Antidepressants like isocarboxazid (Marplan), phenelzine (Nardil), imipramine (Tofranil), and tranylcypromine (Parnate)

• Antipsychotics such as chlorpromazine (Thorazine), risperidone (Risperdal), and quetiapine (Seroquel)

• Antibiotics like erythromycin, clarithromycin (Biaxin), rifampin (Rifadin, Rimactane), ciprofloxacin (Cipro), and rifabutin (Mycobutin)

• Fungal medication, including voriconazole (Vfend), ketoconazole (Nizoral), and itraconazole (Sporanox)

• HIV drugs like atazanavir (Reyataz) and ritonavir (Norvir)

• Supplements/herbs like St. John’s wort, kratom, kava, German chamomile, passionflower, melatonin, and valerian

• Anticonvulsant drugs such as topiramate (Topamax), phenobarbital (Solfoton, Luminal), and phenytoin (Dilantin)

• Antinausea medicines like trimethobenzamide (Tigan) and promethazine (Phenergan)

• Alcohol, marijuana

This is not an exhaustive list of drug interactions. Make sure to review with your doctor any and all medications or supplements you take regularly or even occasionally to ensure there are no interactions.

Can I drink alcohol while taking zolpidem?

Drinking alcohol while taking zolpidem is not recommended. It greatly increases your risk of side effects such as drowsiness and sedation. If you drink alcohol, talk with your doctor about how you can do so safely.

What to discuss with your doctor before taking zolpidem

Here are some things you should review and discuss with your doctor before taking zolpidem:

• Any medical problems you have had in the past or are currently being treated for, such as sleep apnea, lung disease, myasthenia gravis, and kidney or liver disease

• All other medications you are currently taking or take occasionally, including over-the-counter products and herbal and nutritional supplements

• Any allergies to medications

• Your alcohol and other recreational drug use and history

• Your career, lifestyle, and hobbies — some side effects of zolpidem may prevent you from engaging in certain activities, such as driving

• Any history of mental illness, depression, or suicidal feelings

• Pregnancy, planned pregnancy, or breastfeeding

• Any planned surgeries, including dental procedures

Stopping zolpidem

Don’t stop taking zolpidem without your doctor’s guidance.

Zolpidem is a controlled substance. There is a risk of physical dependence and addiction. If you have been consistently taking the medication for a while, suddenly stopping it may cause withdrawal symptoms. These might include emotional changes, muscle cramps, flushing, sweating, shakiness, confusion, seizures, and vomiting.¹⁶

Drug approval history

The FDA approved zolpidem in 1992 to be sold under the brand name Ambien. The drug became available as a generic medication in 2007.¹⁷

Tips for taking zolpidem

• Have a consistent and regular bedtime routine.

• Plan and ensure you have 7–8 hours for sleeping on nights that you take zolpidem.

• Do not consume alcohol while taking zolpidem to avoid possible side effects.

• Taking more than one sleeping pill per night is not recommended.

• Bear in mind that eating immediately before taking zolpidem may slow the drug’s effects.

• Store zolpidem at room temperature in a cool, dry place away from sunlight. Don’t store it in the bathroom.

Frequently asked questions

What is zolpidem used for?

Zolpidem is used to treat insomnia. It helps you get to sleep quickly and reduces your likelihood of waking in the middle of the night. It should be used alongside other non-pharmaceutical insomnia treatments.

Is zolpidem addictive?

Zolpidem is a powerful sedative for people with insomnia. If taken for an extended period, users can develop dependence or addiction.

Is zolpidem an opioid?

Zolpidem is not an opioid or a benzodiazepine but may cause similar effects.