TOPIC: Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: The FDA is requiring the Boxed Warning, FDA's most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.
Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.
BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.
Health Care Professionals
- Consider the patient's condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction, available at: http://bit.ly/3lfHUIG.
- Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.
- Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.
- Take precautions when benzodiazepines are used in combination with opioid addiction medications, available at: http://bit.ly/3eNL9ET.
Patients, Parents, and Caregivers
- Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.
- Take benzodiazepines and all medicines exactly as prescribed by your health care professional
- Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.
- Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.
- Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Estazolam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take certain opiate medications for cough such as codeine (in Triacin-C, in Tuzistra XR) or hydrocodone (in Anexsia, in Norco, in Zyfrel) or for pain such as codeine (in Fiorinal), fentanyl (Actiq, Duragesic, Subsys, others), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Astramorph, Duramorph PF, Kadian), oxycodone (in Oxycet, in Percocet, in Roxicet, others), and tramadol (Conzip, Ultram, in Ultracet). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take estazolam with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.
Drinking alcohol or using street drugs during your treatment with estazolam also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol or use street drugs during your treatment.
Why is this medication prescribed?
Estazolam is used for the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Estazolam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow sleep.
How should this medicine be used?
Estazolam comes as a tablet to take by mouth. It is usually taken as needed at bedtime or after going to bed and having difficulty falling asleep. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take estazolam exactly as directed.
You will probably become very sleepy after you take estazolam and may remain sleepy for some time. Plan to go to bed right after you take estazolam and to stay in bed for a full night. Do not take estazolam if you will be unable to remain asleep for a full night after you take the medication.
Your sleep problems should improve within 7 to 10 days after you start taking estazolam. Call your doctor if your sleep problems do not improve during this time, if they worsen at any time during your treatment, or if you notice any unusual changes in your thoughts or behavior.
Estazolam can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor.
If your doctor has told you to take estazolam regularly, talk to your doctor before you stop taking this medication. Your doctor will probably decrease your dose gradually. If you suddenly stop taking estazolam, you may experience withdrawal symptoms such as difficulty falling asleep or staying asleep, uncontrollable shaking of a part of the body, stomach and muscle cramps, vomiting, sweating, sad mood, seeing things or hearing sounds that do not exist, and seizures.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with estazolam 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 http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm or the manufacturer's website to obtain the Medication Guide.
Other uses for this medicine
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking estazolam,
- tell your doctor and pharmacist if you are allergic to estazolam; any other medications, or any of the ingredients in estazolam tablets. Ask your doctor or pharmacist for a list of the ingredients.
- tell your doctor if you are taking ketoconazole (Nizoral) or itraconazole (Onmel, Sporanox). Your doctor will probably tell you not to take estazolam if you are taking either of these medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antibiotics such as erythromycin (E.E.S., Erythrocin, E-Mycin); antidepressants; antihistamines; barbiturates such as phenobarbital or pentobarbital; cimetidine (Tagamet); digoxin (Lanoxin); diltiazem (Cardizem, Tiazac); disulfiram (Antabuse); fluvoxamine (Luvox); isoniazid (Laniazid, in Rifamate, in Rifater); medications for mental illness or nausea; medications for seizures such as carbamazepine (Equetro, Tegretol, Teril) and phenytoin (Dilantin, Phenytek); monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); nefazodone; rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sleeping pills; and tranquilizers. Many other medications may also interact with estazolam, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you drink or have ever drunk large amounts of alcohol, used or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have ever thought about killing or harming yourself or planned or tried to do so and if you have or have ever had depression, mental illness, seizures, breathing problems or lung disease, or kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking estazolam, call your doctor immediately.
- talk to your doctor about the risks and benefits of taking estazolam if you are 65 years of age or older. Older adults should not usually take estazolam because it is not as safe as other medications that can be used to treat the same condition.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking estazolam.
- you should know that this medication may make you drowsy during the daytime. Do not drive a car or operate machinery until you know how this medication affects you.
- tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
- you should know that some people who took medications for sleep got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, or were involved in other activities while partially asleep. After they woke up, these people were usually unable to remember what they had done. Call your doctor right away if you find out that you have been driving or doing anything else while you were sleeping.
What should I do if I forget a dose?
You will probably be told to take estazolam as needed. If your doctor tells you to take estazolam regularly and you miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one and do not take estazolam unless you are ready to go to bed and stay asleep for a full night.
What side effects can this medication cause?
Estazolam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- hangover effect (grogginess)
- dry mouth
- changes in behavior
- slowed or uncoordinated movements
- muscle stiffness
- leg pain
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- hallucinations (seeing things or hearing voices that do not exist)
- thinking about harming or killing yourself or planning or trying to do so
- memory problems
Estazolam 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
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. http://www.upandaway.org
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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Signs of overdose may include the following:
- slowed breathing
- loss of coordination
- slurred speech
- coma (loss of consciousness for a period of time)
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Estazolam 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.
¶ This branded product is no longer on the market. Generic alternatives may be available.