Restoril

Restoril is a prescription-only benzodiazepine prescribed for the short-term management of insomnia (inability to fall asleep or maintain a sleep).

Benzodiazepines are central nervous system (CNS) depressants, which suppress the functions of CNS. It is available as:

• Tablet
• Capsule

Before using Restoril, you must know all about the risks and complications associated with it. Together with your doctor, you can decide whether the medication will do you more goods than the harms.

Here are some factors to be considered before deciding to use this medicine:

Allergies: Inform your doctor about the allergies you have, such as to this medication, other medications, or to foods, dyes, or preservatives.

Pediatric: Safety and efficacy of this medicine in children have not been well documented.

Geriatric: It may be used in elderly after adjusting the doses.

Pregnancy: It falls under pregnancy category X for all trimesters meaning that this drug is not recommended to be used during or near a pregnancy.

Breastfeeding: Use only after assessing risks and benefits of the use.

Drug Interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions.

Temazepam is not recommended to be used with Flumazenil.

Though usually not recommended, your doctor may decide, after adjusting dose or frequency of one or both medicines, to use this medicine with:

• Alfentanil
• Anileridine
• Bromazepam
• Buprenorphine
• Butabarbital
• Butalbital
• Carbinoxamine
• Carisoprodol
• Chloral Hydrate
• Chlorzoxazone
• Codeine
• Dantrolene
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Fospropofol
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meclizine
• Meperidine
• Mephenesin
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Mirtazapine
• Morphine
• Oxycodone
• Oxymorphone
• Phenobarbital
• Primidone
• Propofol
• Propoxyphene
• Remifentanil
• Sodium Oxybate
• Sufentanil
• Suvorexant
• Tapentadol
• Zolpidem

Rarely and only when absolutely needed, this medicine may be used with the following medicines even if using them together may put you at risk of certain side effects.

In such cases, you may have to take the adjusted dose or change the frequency of intake.

• Rifapentine
• St John's Wort
• Theophylline

Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions.

Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe. DO NOT drink alcohol while taking this medicine.

Inform your doctor about any other medical problems you have, including:

• History of addiction to alcohol or drug
• Breathing troubles or lung disease
• Mental depression or other mental disorders in the past: Use cautiously.
• Kidney or liver impairment: Use cautiously.

To use Restoril properly, you must follow all instructions given by your doctor and do not take more, less, more frequently or for a longer duration than recommended.

Read the patient information leaflet carefully and follow accordingly. Consult your doctor if you have any query. Use this medicine right before your bedtime.

Dosing: For best results, follow your doctor to know what amount of medicine you should take in a single dose.

The doses of a medicine can differ according to the conditions for which it is being prescribed, your age and your overall health status.

Remember your doses can differ. Consult your doctor if you have anything to ask. The doses of capsules to treat insomnia (sleep problems are:

The doses of capsules to treat insomnia, sleep problems are:

• Adults: 15 milligrams (mg) before sleep. The doses may be adjusted as required.
• Older adults: Starting with 7.5 mg before sleep, the doses may be adjusted as required.
• Children: Your doctor will decide the use and dose.

Missed Dose: Take your missed dose once you remember but avoid it if it’s time to take your next dose, and follow your normal dosing schedule. Avoid taking double doses to make up for the missed dose.

Storage:

• Store in a closed container at room temperature.
• Keep away from heat, moisture, and direct light.
• Do not freeze.
• Keep away from children.
• Discard any unused or expired medicines.

Before using Restoril, there are some precautions you must take. Your progress should be regularly monitored to determine if you are responding to the treatment. You may also need a blood test to look for any undesirable effects.

Do not get pregnant while using this medicine. If you suspect a pregnancy during or 2 months after completion of therapy, consult your doctor immediately.

Consult your doctor if you engage in any activities such as driving, walking, or eating food while in sleep or half-awake.

Avoid taking alcohol or other CNS depressants such as allergy or cold medicines, sleeping pills, narcotic pain killers, medicine for seizures, muscle relaxants, or other anesthetics.

Concomitant use of alcohol or other CNS depressants and temazepam can cause severe breathing troubles and loss of consciousness.

You may feel dizzy or lightheaded while taking this medicine. Therefore, exercise extra caution while driving, using machines or doing any activity that requires alertness.

See your doctor immediately if you behave like being drunk or have other serious signs such as confusion, depressive or suicidal thoughts, hallucinations, and mania, nervousness, or irritability.

Do not discontinue temazepam until suggested by your doctor. Your doctor may taper the doses to prevent or reduce the incidence of withdrawal symptoms, such as seizures, hallucinations, stomach or muscle cramps, shaking, or unusual behavior.

Seek emergency medical help if you think you or someone has an overdose of this medicine.

Seek emergency medical help if you have any of the signs of life-threatening allergic reaction, anaphylaxis, including:

• Rapid and irregular breathing
• Shortness of breath or wheezing
• Fainting
• Unusual skin color in the face
• Rapid and irregular heart rhythm or pulse
• Hives
• Swollen eyelids or areas around

Inform your doctor about your intake of this medicine before going for any kind of medical test.

See your doctor if you do not seem to respond to the medicine after a week of intake of temazepam, or if your condition worsens.

Make sure you meet with your doctor in using Restoril to avoid unwanted potential side effects.

Consult your doctor immediately if you have any of the following side effects:

Less common: 

• Altered mood
• Euphoria
• Unusual fear or nervousness

Rare:

• Balance and coordination troubles
• Breathing difficulty
• Chest discomfort
• Hallucinations
• Memory problems
• Rapid and irregular heartbeat or pulse
• Shallow or noisy breathing
• Unusual dreams
• Unusual excitement, nervousness, restlessness, or irritability
• Unusual movements of the eye

Incidence not known:

• Convulsions
• Muscle or stomach cramps
• Sweating
• Tremors in the legs, arms, hands, or feet
• Vomiting

Seek emergency medical help if you have any of the Symptoms of Overdose, including:

• Altered consciousness
• Bluish lips, fingernails, or skin
• Blurry vision
• Breathing troubles
• Confusion
• Excessive tiredness or weakness
• Feeling dizzy or fainting when changing the position
• Slowed response
• Unconsciousness
• Unusual sleepiness

Non-serious side effects usually go away on their own without requiring medical intervention. You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including:

Less common: 

• Diarrhea
• Dryness in mouth
• A headache or dizziness
• Nausea
• Slowed response or thinking

Rare: 

• Backache
• Burning sensations in the eyes

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.