Restoril

Temazepam is used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep). Temazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow sleep.

GENERIC AVAILABLE: Yes

Temazepam and other benzodiazepines have been associated with fetal damage, including congenital malformations, when taken by pregnant women in their first trimester. Temazepam should be avoided during pregnancy.

Use by nursing mothers has not been adequately studied.

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

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

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.

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.

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.

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.

Restoril™ (temazepam) Capsules USP

Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and M® on the other side in red, and a blue cap imprinted “RESTORIL 7.5 mg” twice in red.

Bottle of 30 .............. NDC 0406-9915-03
Bottle of 100 ............ NDC 0406-9915-01

Maroon and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and M® on the other side in red, and a maroon cap imprinted “RESTORIL 15 mg” twice in white.

Bottle of 100 ............ NDC 0406-9916-01

Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and M® on the other side in red, and an opaque blue cap imprinted “RESTORIL 22.5 mg” twice in red.

Bottle of 30 .............. NDC 0406-9914-03

Maroon and blue capsules, with the blue body imprinted “FOR SLEEP” on one side and M® on the other side in red, and a maroon cap imprinted “RESTORIL 30 mg” twice in white.

Bottle of 100 ............ NDC 0406-9917-01

Dispense in a well-closed, light-resistant container with a child-resistant closure.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Mallinckrodt Inc., Hazelwood, MO 63042 USA. Revised: Nov 2014

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of temazepam in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of temazepam. Elderly patients may require a lower dose to help reduce unwanted effects.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For insomnia (trouble sleeping):
    • Adults—15 milligrams (mg) at bedtime. Your doctor may adjust your dose if needed.
    • Older adults—At first, 7.5 mg at bedtime. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Specific Drugs

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Provide patient with a copy of manufacturer’s patient information.a

• Importance of taking only as prescribed; do not increase dosage or duration of therapy unless otherwise instructed by a clinician.a

• Importance of informing clinicians of any behavioral or mental changes, memory impairment, tolerance, or dependence/withdrawal symptoms.a

• Importance of taking only when able to get a full night’s sleep (i.e., 7–8 hours) before being active again.a

• Potential for drug to impair mental alertness or physical coordination; use caution when operating machinery or performing hazardous tasks until effects on individual are known.a

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescriptions and OTC drugs, and of concomitant illnesses, particularly depression.a

• Importance of not consuming alcoholic beverages.a

• Risk of rebound insomnia for 1 or 2 nights after discontinuance.a

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b

• Importance of informing patients of other important precautionary information. (See Cautions.)a

Use Restoril as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take this medicine right before you get into bed.
• Do not take Restoril (temazepam) unless you can get a full night's sleep (at least 7 to 8 hours) before you need to be active again.
• Use this medicine only for short periods of time (7 to 10 days).

What do I do if I miss a dose?

• Many times Restoril is taken on an as needed basis. Do not take more often than every 24 hours unless told to do so by your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Restoril, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Restoril. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Restoril.

Review Date: October 4, 2017

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

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.

Take Restoril exactly as it was prescribed for you. Follow all directions on your prescription label. Never use Restoril in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in treating your symptoms.

Temazepam may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

You should not even share this medicine with another person who has the same symptoms you have.

Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

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

Do not take temazepam unless you are able to get a full night's sleep before you must be active again.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using temazepam.

Restoril should be used for only a short time to treat insomnia. Call your doctor if your symptoms do not improve after 7 to 10 nights of treatment, or if this medicine seems to stop working as well in helping you fall asleep and stay asleep.

Do not stop using Restoril suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Your insomnia symptoms may also return when you stop using the medicine. Ask your doctor how to safely stop taking temazepam.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Temazepam is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Since Restoril is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medicine if you do not have at least 7 to 8 hours to sleep before being active again. Do not take extra medicine to make up a missed dose.

More frequent side effects include: dizziness, insomnia, lethargy, and irritability. See below for a comprehensive list of adverse effects.

Applies to temazepam: oral capsule, oral tablet

Along with its needed effects, temazepam (the active ingredient contained in Restoril) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking temazepam:

• False or unusual sense of well-being
• fear or nervousness
• mood or mental changes

• Difficult or labored breathing
• fast, irregular, pounding, or racing heartbeat or pulse
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• loss of appetite
• loss of memory
• nightmares
• problems with memory
• seeing, hearing, or feeling things that are not there
• shakiness and unsteady walk
• tightness in the chest
• uncontrolled eye movements
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual excitement, nervousness, restlessness, or irritability
• weight loss

• Muscle cramps
• seizures
• shakiness in the legs, arms, hands, or feet
• stomach cramps
• sweating
• trembling or shaking of the hands or feet
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking temazepam:

• Blurred vision
• change in consciousness
• confusion
• decreased or absent reflexes
• difficult or troubled breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular, fast, slow, or shallow breathing
• loss of consciousness
• pale or blue lips, fingernails, or skin
• sleepiness or unusual drowsiness
• unusual tiredness or weakness

Some side effects of temazepam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• dry mouth
• feeling of constant movement of self or surroundings
• headache
• nausea
• sensation of spinning
• unusual dullness or feeling of sluggishness

• Backache
• burning eyes

AU, US: Caution is recommended. UK: Use is contraindicated. Excreted into human milk: Yes Comments: This drug may cause drowsiness and feeding difficulties in the infant.