Temazepam Capsules

What is this medication?

TEMAZEPAM (te MAZ e pam) treats insomnia. It helps you go to sleep faster and stay asleep through the night. It is often used for a short period of time. It belongs to a group of medications called benzodiazepines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Restoril

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Liver disease
• Lung or breathing disease
• Mental health condition
• Myasthenia gravis
• Parkinson's disease
• Porphyria
• Seizures or a history of seizures
• Substance use disorder
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to temazepam, other benzodiazepines, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. It is only for use at bedtime. Follow the directions on the prescription label. Swallow the tablets or capsules with a drink of water. If it upsets your stomach, take it with food or milk. Do not take your medication more often than directed. Do not stop taking except on the advice of your care team.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Opioid medications for cough
• Sodium oxybate

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Certain medications for anxiety or sleep
• Certain medications for depression, such as amitriptyline, fluoxetine, sertraline
• Certain medications for seizures, such as phenobarbital, primidone
• General anesthetics, such as lidocaine, pramoxine, tetracaine
• Medications that relax muscles for surgery
• Opioid medications for pain
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not stop taking this medication except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take. Long term use of this medication may cause your brain and body to depend on it. This can happen even when used as directed by your care team. You and your care team will work together to determine how long you will need to take this medication.

Plan to go to bed and stay in bed for a full night (7 to 8 hours) after you take this medication. You may still be drowsy the morning after taking this medication. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

If you are taking another medication that also causes drowsiness, you may have more side effects. Give your care team a list of all medications you use. Your care team will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have problems breathing or unusual sleepiness.

You may do unusual sleep behaviors or activities you do not remember the day after taking this medication. Activities include driving, making or eating food, talking on the phone, sexual activity, or sleep walking. Stop taking this medication and call your care team right away if you find out you have done activities like this.

After you stop taking this medication, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Unusual sleep behaviors or activities you do not remember such as driving, eating, or sexual activity

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness the day after use
• Headache
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

This medication may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medication with a substance like cat litter or coffee grounds. Then throw the medication away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medication after the expiration date.

Store at room temperature below 30 degrees C (86 degrees F). Protect from light. Keep container tightly closed.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.