Temazepam

Temazepam is indicated for the short-term treatment of insomnia (generally 7 - 10 days).

For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7-10 days).

The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.

• Temazepam is available under the following different brand names: Restoril

Common side effects of Temazepam include:

• day-time drowsiness or "hangover" feeling, 
• Drowsiness
• Dizziness
• Lethargy
• Diarrhea
• Euphoria
• Weakness
• Confusion
• Spinning sensation (vertigo)

Serious side effects of Temazepam include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• nausea, 
• vomiting, 
• weak or shallow breathing, 
• difficult to wake up, 
• breathing that stops, 
• confusion, 
• agitation, 
• hallucinations, 
• depressed mood, 
• thoughts of self-harm, and
• activities (driving, eating, making phone calls, or having sex) and having no memory of the activity

Rare side effects of Temazepam include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule: Schedule IV

• 7.5 mg
• 15 mg
• 22.5 mg
• 30 mg

Insomnia

Adult dosage

• 15-30 mg orally once daily before bedtime
• Debilitated patients: 7.5 mg orally once daily before bedtime
• Discontinuation: gradually taper after extended therapy; abrupt discontinuation should be avoided

Dosing Considerations – Should be Given as Follows:

Insomnia

• Adult: 15-30 mg orally at bedtime
• Debilitated patients: 7.5 mg orally at bedtime
• Geriatric: 7.5 mg orally at bedtime; limit use to 10-14 days
• A preferred drug in the elderly when benzodiazepine indicated because of lack of active metabolite
• Discontinuation: Gradually taper after extended therapy; abrupt discontinuation should be avoided
• Pediatric: Safety and efficacy not established

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Temazepam has severe interactions with the following drugs:
  • calcium/magnesium/potassium/sodium oxybates
  • sodium oxybate
• Temazepam has serious interactions with at least 12 other drugs.
• Temazepam has moderate interactions with at least 186 other drugs.
• Temazepam has minor interactions with at least 13 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist about all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains temazepam
• Do not take Restoril if you are allergic to temazepam or any ingredients contained in this drug
• In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Documented hypersensitivity
• Acute alcohol intoxication
• Narrow-angle glaucoma (questionable)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Temazepam?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Temazepam?”

Cautions

• Use caution in COPD, sleep apnea, renal/hepatic disease, impaired gag reflex, open-angle glaucoma (questionable), alcoholism, respiratory disease, depression, suicidal ideation
• May impair the ability to perform hazardous tasks
• Caution with IV use in shock, coma, and depressed respiration and in patients who recently received other respiratory depressants
• Anterograde amnesia may occur
• Use caution in patients with a history of drug abuse or acute alcoholism; tolerance, psychological and physical dependence may occur with prolonged use
• Use in myasthenia gravis is allowed in limited circumstances
• Use caution in severe respiratory depression and depressed neuroses, psychotic reactions
• Paradoxical hyperactive aggressive behavior reported
• Therapy can cause drowsiness and a decreased level of consciousness; patients, particularly the elderly, are at higher risk of falls
• May cause hyperactive or aggressive behavior
• Use of drugs, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of drugs along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency
• Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of the unused drugs; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate
• For patients using treatment more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose)
• Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher doses and those who have had longer durations of use
• In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months

Pregnancy

• Do not use it in pregnancy. 
• The risks involved outweigh the potential benefits.
• Safer alternatives exist. 

Lactation

• Avoid if you are breastfeeding. 
• Minor tranquilizers should be avoided in 1st trimester of pregnancy due to the increased risk of congenital malformations
• Maternal use shortly before delivery is associated with floppy infant syndrome (good and consistent evidence)
• Prenatal benzodiazepine exposure slightly increased oral cleft risk (limited or inconsistent evidence)