AUDIENCE:Patient, Health Professional, Pharmacy
ISSUE:FDAis advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with
than other prescription medicines used for sleep.
BACKGROUND:Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.
If patients experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine you should:
Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Healthcare Professionals should advise all patients that:
Zolpidem is used to treat insomnia (difficulty falling asleep or staying asleep). Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.
Zolpidem comes as a tablet (Ambien) and an extended-release (long-acting) tablet (Ambien CR) to take by mouth. Zolpidem also comes as a sublingual tablet (Edluar, Intermezzo) to place under the tongue and an oral spray (Zolpimist), which is sprayed into the mouth over the tongue. If you are taking the tablets, extended-release tablets, sublingual tablets (Edluar), or oral spray, you will take the medication as needed, not more than one time a day, immediately before bedtime. If you are taking the sublingual tablets (Intermezzo), you will take the medication as needed, not more than one time during the night if you wake up and have difficulty returning to sleep. Zolpidem will work faster if it is not taken with a meal or immediately after a meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use zolpidem exactly as directed.
You will probably become very sleepy soon after you take zolpidem and will remain sleepy for some time after you take the medication. Plan to go to bed right after you take zolpidem tablets, extended-release tablets, sublingual tablets (Edluar), and oral spray and to stay in bed for 7 to 8 hours. Take zolpidem sublingual tablets (Intermezzo) only when you are already in bed and can remain in bed for at least 4 more hours. Do not take zolpidem if you will be unable to remain asleep for the required number of hours after taking the medication. If you get up too soon after taking zolpidem, you may experience drowsiness and problems with memory, alertness, or coordination.
Swallow the extended-release tablets whole; do not split, chew, or crush them. Tell your doctor or pharmacist if you cannot swallow tablets.
Do not open the pouch that contains the sublingual tablet (Intermezzo) until you are ready to take the tablet. To remove the sublingual tablet (Edluar) from the blister pack, peel off the top layer of paper and push the tablet through the foil. To take either brand of sublingual tablet, place the tablet under your tongue, and wait for it to dissolve. Do not swallow the tablet whole or take the tablet with water.
To use the oral spray, follow these directions and those that appear in the package label:
Your sleep problems should improve within 7 to 10 days after you start taking zolpidem. Call your doctor if your sleep problems do not improve during this time or if they get worse at any time during your treatment.
Zolpidem should normally be taken for short periods of time. If you take zolpidem for 2 weeks or longer, zolpidem may not help you sleep as well as it did when you first began to take the medication. Talk to your doctor about the risks of taking zolpidem for 2 weeks or longer.
Zolpidem may be habit forming. Do not take a larger dose of zolpidem, take it more often, or take it for a longer time than prescribed by your doctor.
Do not stop taking zolpidem without talking to your doctor, especially if you have taken it for longer than 2 weeks. If you suddenly stop taking zolpidem, you may develop unpleasant feelings or mood changes or you may experience other withdrawal symptoms such as shakiness, lightheadedness, stomach and muscle cramps, nausea, vomiting, sweating, flushing, tiredness, uncontrollable crying, nervousness, panic attack, difficulty falling asleep or staying asleep, uncontrollable shaking of a part of your body, and rarely, seizures.
You may have more difficulty falling asleep or staying asleep on the first night after you stop taking zolpidem than you did before you started taking the medication. This is normal and usually gets better without treatment after one or two nights.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with zolpidem and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking zolpidem,
Unless your doctor tells you otherwise, continue your normal diet.
This medication is taken as needed. You may take zolpidem even if it is later than the usual time, as long as you will be able to remain in bed for the required number of hours after you take it.
Zolpidem may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:
Zolpidem may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat, light, and moisture (not in the bathroom). Do not freeze zolpidem oral spray. Store the zolpidem oral spray bottle upright.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
Keep all appointments with your doctor.
Do not let anyone else take your medication. Zolpidem is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: May 15, 2019.