Restoril

DRUG DESCRIPTION

Restoril™ (temazepam) is a benzodiazepine hypnotic agent. The chemical name is 7-chloro1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is:

Restoril™  (temazepam)  Structural Formula Illustration

C16H13ClN2O2     MW = 300.74

Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP.

Restoril™ (temazepam) capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration.

7.5 mg, 15 mg, 22.5 mg, and 30 mg Capsules

Active Ingredient: temazepam USP

7.5 mg Capsules

Inactive Ingredients:FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.

May also include: n-butyl alcohol, iron oxide red, shellac, shellac glaze, SD-35A alcohol.

15 mg Capsules

Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.

May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.

22.5 mg Capsules

Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.

May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.

30 mg Capsules

Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.

May also include: n-butyl alcohol, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.

What are the possible side effects of temazepam (Restoril)?

Temazepam may cause a severe allergic reaction. Stop taking temazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using temazepam and call your doctor at once if you have any of these serious side effects:

  • weak or shallow breathing;
  • ...

Read All Potential Side Effects and See Pictures of Restoril »

What are the precautions when taking temazepam (Restoril)?

Before taking temazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., lorazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, mental/mood problems (e.g., depression, panic disorder), lung problems (e.g., pulmonary insufficiency, sleep apnea), seizures, personal or family history of regular use/abuse of drugs/alcohol/other substances.

This drug may make you dizzy or drowsy or cause temporary blurred vision. Do not drive, use machinery, or do any activity...

Read All Potential Precautions of Restoril »


Restoril Consumer (continued)

SIDE EFFECTS: Dizziness, loss of coordination, or blurred vision may occur. To minimize falls, remember to get up slowly when rising from a seated or lying position. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking temazepam.

Tell your doctor immediately if any of these unlikely but serious side effects occur: confusion, unusual feelings of well-being (euphoria), uncontrolled movements (tremor), restlessness, memory loss, sweating, mental/mood changes (e.g., hallucinations, agitation, anxiety, unusual/disturbing thoughts, depression, rare thoughts of suicide), increased or vivid dreams, vision changes, fainting.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), unusual paleness, unusual tiredness, fast/pounding/irregular heartbeat, yellowing of the eyes/skin, dark urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking temazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., lorazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, mental/mood problems (e.g., depression, panic disorder), lung problems (e.g., pulmonary insufficiency, sleep apnea), seizures, personal or family history of regular use/abuse of drugs/alcohol/other substances.

This drug may make you dizzy or drowsy or cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness, dizziness, loss of coordination, and confusion.

Temazepam must not be used during pregnancy. Other medications in this class have caused birth defects when used in the first three months of pregnancy. Other medications in this class have also caused unusual drowsiness, feeding problems, and liver problems in newborns when used at or near the time of delivery, or withdrawal symptoms in newborns when used for a long time during pregnancy. If you are a woman of childbearing age, use an effective form of birth control while taking this drug. If you plan to become pregnant, stop taking this drug before doing so. If you become pregnant or think you may be pregnant, inform your doctor immediately.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Restoril Patient Information Including Side Effects

Brand Names: Restoril

Generic Name: temazepam (Pronunciation: te MAZ e pam)

  • What is temazepam (Restoril)?
  • What are the possible side effects of temazepam (Restoril)?
  • What is the most important information I should know about temazepam (Restoril)?
  • What should I discuss with my healthcare provider before taking temazepam (Restoril)?
  • How should I take temazepam (Restoril)?
  • What happens if I miss a dose (Restoril)?
  • What happens if I overdose (Restoril)?
  • What should I avoid while taking temazepam (Restoril)?
  • What other drugs will affect temazepam (Restoril)?
  • Where can I get more information?

What is temazepam (Restoril)?

Temazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Temazepam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Temazepam is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Temazepam may also be used for other purposes not listed in this medication guide.

What are the possible side effects of temazepam (Restoril)?

Temazepam may cause a severe allergic reaction. Stop taking temazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using temazepam and call your doctor at once if you have any of these serious side effects:

  • weak or shallow breathing;
  • fast or pounding heartbeats;
  • confusion, slurred speech, unusual thoughts or behavior;
  • hallucinations, agitation, aggression;
  • thoughts of suicide or hurting yourself;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • problems with urination; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • daytime drowsiness (or during hours when you are not normally sleeping);
  • amnesia or forgetfulness;
  • muscle weakness, lack of balance or coordination;
  • numbness, burning, pain, or tingly feeling;
  • headache, blurred vision, depressed mood;
  • feeling nervous, excited, or irritable;
  • nausea, vomiting, stomach discomfort; or
  • dry mouth, increased thirst.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about temazepam (Restoril)?

Temazepam may cause a severe allergic reaction. Stop taking temazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Take temazepam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking temazepam and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to temazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or triazolam (Halcion).

This medication can cause birth defects in an unborn baby, or withdrawal symptoms in a newborn. Do not use temazepam if you are pregnant.

Before taking temazepam, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, myasthenia gravis, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking temazepam. It can increase some of the side effects, and could possibly cause a fatal overdose.

Avoid using other medicines that make you sleepy. They can add to sleepiness caused by temazepam.

Temazepam may be habit-forming and should be used only by the person it was prescribed for. Temazepam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Related Drug Centers
  • Restoril


Related Drugs Index: