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Description

Generic Name

Temazepam

Active Ingredient

Temazepam

Chemical Name and Composition

Temazepam is chemically described as 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one.

Temazepam is a white, crystalline substance that is very slightly soluble in water and sparingly soluble in alcohol. It has a molecular weight of about 300.74.

Medication Classification

Restoril is a benzodiazepine used to treat sleep problems. It works by enhancing the activity of gamma-aminobutyric acid (GABA), a natural chemical in the brain that calms nerve activity. This calming effect helps you fall asleep and stay asleep.

Restoril is a Schedule IV (CIV) controlled substance under U.S. federal law.

Indication

Restoril is indicated for the short-term treatment of insomnia, generally 7 to 10 days. It is used in adults who have trouble falling asleep, staying asleep, or who wake up too early.

Dosage Form and Available Strengths

• Dosage Form: Oral capsules
• Route of Administration: Oral
• Available Strengths: 7.5 mg, 15 mg, 22.5 mg, and 30 mg

Inactive Ingredients

Inactive ingredients vary by strength and manufacturer. Restoril capsules may contain lactose, magnesium stearate, colloidal silicon dioxide, corn starch, talc, gelatin, titanium dioxide, and colorants that differ by capsule strength. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Restoril exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your age, your overall health, and your response. Do not change your dose or take it longer than directed.

How to Take Restoril

• Swallow the capsule whole with water.
• Take Restoril right before bedtime, only when you are able to stay in bed for a full night (7 to 8 hours) before you need to be active again.
• Take it only when you can get a complete night's sleep. Taking it with less time available raises the risk of memory problems, drowsiness, and trouble with daily activities.
• Do not take more than prescribed, and do not take it more often than directed.

Food Considerations

Restoril may be taken with or without food. Taking it right after a meal may slow how quickly it starts to work, so it is often best taken on an empty stomach at bedtime. Avoid alcohol entirely while taking Restoril, as the combination can cause dangerous drowsiness and slowed breathing.

Missed Dose Instructions

• Restoril is usually taken only at bedtime when needed, so a missed dose is often not a concern.
• If you forget to take it and are still able to get a full night of sleep, you may take it as directed.
• Do not take Restoril if you cannot stay in bed for a full 7 to 8 hours afterward.
• Do not take two doses at once to make up for a missed dose.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children.

Disposal

Because Restoril is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, follow current FDA guidance for safe household disposal. Ask your pharmacist if you have questions about disposal.

Special Instructions

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of Restoril, including drowsiness, dizziness, confusion, and unsteadiness, which can raise the risk of falls. A provider may start at a lower dose, such as 7.5 mg, and monitor closely. Take extra care when getting up during the night.

Patients with Liver or Kidney Problems: Use with caution. A lower dose may be needed, since impaired organ function can increase drug levels and prolong effects.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, trouble waking the patient, unusual behavior during sleep, or new or worsening mood changes, and seek care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking Restoril suddenly after regular or prolonged use. Abrupt discontinuation can cause withdrawal symptoms, some of which may be serious.
• If you and your provider decide to stop treatment, the dose should be reduced gradually using a plan set by your provider.
• Withdrawal symptoms may include anxiety, trouble sleeping (rebound insomnia), irritability, sweating, tremor, stomach or muscle cramps, and, in severe cases, seizures.
• Rebound insomnia, where sleep problems return worse than before, may occur for a night or two after stopping. This usually improves on its own.
• Tell your provider if withdrawal symptoms occur so your taper can be adjusted.

Overdose Warning

An overdose of Restoril can be serious and may be fatal, especially when combined with opioids, alcohol, or other central nervous system (CNS) depressants. Symptoms of overdose may include:

• Extreme drowsiness or difficulty staying awake
• Confusion
• Slurred speech
• Loss of coordination or unsteadiness
• Slowed or shallow breathing
• Weak or limp muscles
• Loss of consciousness or coma

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. A medicine called flumazenil may be used in some cases to reverse the effects of benzodiazepines.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Restoril and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Complex sleep behaviors: Doing activities while not fully awake, such as sleep-walking, sleep-driving, preparing or eating food, making phone calls, or having sex, with no memory of the event. These behaviors can cause serious injury or death. Stop taking Restoril and tell your provider if this happens.
• Respiratory depression: Slow, shallow, or difficult breathing, or extreme sleepiness, especially when combined with opioids or other CNS depressants.
• Severe allergic reactions (including angioedema): Swelling of the face, lips, tongue, or throat; trouble breathing or swallowing; hives; or a severe rash. These can be life-threatening and may occur after the first dose or later.
• Suicidal thoughts or worsening depression: New or worsening depression, or thoughts of harming yourself.
• Abnormal thinking or behavior changes: Unusual aggression, agitation, hallucinations, confusion, or feeling detached from reality.
• Memory loss (amnesia): Trouble remembering events that happened after taking the medication.
• Worsening or rebound insomnia: A serious return of sleep problems, which may signal an underlying condition.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Drowsiness or sleepiness
• Dizziness or lightheadedness
• Headache
• Dry mouth
• Fatigue or feeling groggy the next day ("hangover" effect)
• Nausea
• Nervousness
• Blurred vision

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

FDA Boxed Warning: Risks from Concomitant Use with Opioids

• Combining benzodiazepines such as Restoril with opioids may result in profound sedation, respiratory depression, coma, and death.
• Reserve concomitant prescribing for patients with no alternative treatment options.
• Limit the dose and duration to the minimum required, and monitor closely for signs of respiratory depression and sedation.

Conditions to Disclose to Your Healthcare Provider

Before taking Restoril, tell your healthcare provider if you have or have had any of the following:

• Breathing problems, such as chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea
• Liver or kidney problems
• Depression, mood problems, or thoughts of suicide
• A history of unusual behavior or complex sleep behaviors while taking a sleep medicine
• Seizures or a seizure disorder
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Myasthenia gravis or other muscle weakness conditions
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take Restoril if you:

• Have a known hypersensitivity to temazepam, other benzodiazepines, or any component of the formulation
• Are pregnant or may become pregnant, as Restoril may harm an unborn baby

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Key interactions include:

• Opioids: Combining Restoril with opioids increases the risk of severe drowsiness, respiratory depression, coma, and death.
• Other CNS depressants: Sedatives, tranquilizers, other sleep medicines, muscle relaxants, certain antidepressants, antihistamines, and antipsychotics can add to drowsiness and breathing problems.
• Alcohol: Drinking alcohol while taking Restoril can dangerously increase sedation and the risk of slowed breathing. Avoid alcohol entirely.
• CYP3A4 inhibitors: Drugs such as certain antifungals, macrolide antibiotics, and HIV medications may increase temazepam levels and the risk of side effects.
• CYP3A4 inducers: Drugs such as rifampin or carbamazepine may reduce temazepam's effectiveness.
• Other sedating medicines: Any medicine that causes drowsiness may increase the sedative effects of Restoril.

Monitoring Requirements

Your healthcare provider may monitor:

• Your response to treatment and whether your sleep improves
• Signs of excessive sedation or respiratory depression, especially with other CNS depressants
• New or worsening mood, behavior, or mental health changes, including thoughts of self-harm
• Reports of complex sleep behaviors
• Signs of tolerance, dependence, or misuse
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Restoril is a Schedule IV controlled substance.

• Benzodiazepines such as Restoril can be misused and may be a target for people who abuse prescription medicines.
• Physical dependence and tolerance can develop with continued use, even at prescribed doses. Physical dependence means you should not stop suddenly.
• Tolerance may develop, meaning the medication may become less effective over time. Do not increase your dose on your own.
• Do not sell or give away Restoril. Doing so may harm others and is against the law.
• Misusing this medication can cause overdose and death, especially when combined with other substances.

Long-Term Use Considerations

• Restoril is intended for short-term use only, generally 7 to 10 days. The safety and effectiveness of long-term use have not been established.
• If your insomnia does not improve within 7 to 10 days, or worsens, tell your provider. This may signal an underlying condition that needs different treatment.
• Physical dependence and tolerance may develop with continued use. Any decision to stop treatment should involve a gradual, supervised taper.
• Do not take Restoril for longer than prescribed without discussing it with your provider.

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Patient Counseling Information

Safe Medication Use

• Take Restoril exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Take it only right before bedtime and only when you can stay in bed for a full 7 to 8 hours.
• Do not take Restoril unless you are able to get a complete night's sleep, to reduce the risk of memory problems and next-day drowsiness.
• Do not stop taking Restoril suddenly after regular use. Talk to your healthcare provider about a safe tapering plan.
• Do not share Restoril with anyone else. Sharing is dangerous and against the law.
• Keep Restoril in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Complex sleep behaviors: Stop taking Restoril and tell your provider right away if you learn you have done activities such as driving, eating, or walking while not fully awake, with no memory of it.
• Opioids and CNS depressants: Do not use these with Restoril unless directed by your provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking Restoril. Alcohol adds to the sedative effect and can be dangerous.
• Driving and machinery: Restoril can cause drowsiness, dizziness, and slowed thinking that may last into the next day. Do not drive or operate heavy machinery until you know how it affects you.
• Next-day impairment: Even if you feel fully awake, your alertness and coordination may still be reduced the morning after taking Restoril.
• Pregnancy: Do not take Restoril if you are pregnant or may become pregnant, as it may harm an unborn baby. Tell your provider right away if you become pregnant.
• Breastfeeding: Temazepam can pass into breast milk. Talk to your provider before breastfeeding while taking Restoril.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Learn you have done activities while asleep or not fully awake, such as sleep-driving or sleep-walking
• Have slow, shallow, or difficult breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Have a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, hives, or trouble breathing
• Develop new or worsening depression, unusual behavior, or thoughts of harming yourself
• Notice memory problems, confusion, hallucinations, or agitation
• Find that your insomnia does not improve or gets worse after 7 to 10 days
• Experience withdrawal symptoms after reducing or stopping the medication
• Have any symptom that concerns you or does not go away