tem-AZ-a-pam

Therapeutic Classification: sedative/hypnotics

Pharmacologic Classification: benzodiazepines

• Short-term management of insomnia (<4 wk).

• Acts at many levels in the CNS, producing generalized depression.
• Effects may be mediated by GABA, an inhibitory neurotransmitter.

• Relief of insomnia.

Absorption: Well absorbed after oral administration.

Distribution: Widely distributed; crosses blood-brain barrier. Probably crosses the placenta and enters breast milk. Accumulation of drug occurs with chronic dosing.

Protein Binding: 96%.

Metabolism/Excretion: Metabolized by the liver.

Half-life: 10–20 hr.

(sedation)

Contraindicated in:

• Hypersensitivity
• Cross-sensitivity with other benzodiazepines may exist
• Pre-existing CNS depression
• Severe uncontrolled pain
• Angle-closure glaucoma
• Impaired respiratory function
• Sleep apnea.

Use Cautiously in:

• Hepatic impairment
• History of suicide attempt or drug addiction
• OB: Use late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in neonates
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children
• Geri: Appears on Beers list. ↑ risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents in older adults. If possible, avoid use in older adults.

Derm: rash.

EENT: blurred vision.

GI: constipation, diarrhea, nausea, vomiting.

Neuro: hangover, abnormal thinking, behavior changes, dizziness, drowsiness, hallucinations, lethargy, paradoxic excitation, sleep driving.
Misc: physical dependence, psychological dependence.

Drug-Drug:

• Use with opioids or other CNS depressants, including other benzodiazepines, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
• May ↓ efficacy of levodopa.
• Rifampin or smoking↑ metabolism and may ↓ effectiveness of temazepam.
• Probenecid may prolong effects of temazepam.
• Sedative effects may be ↓ by theophylline.

Drug-Natural Products:

• Concomitant use of kava-kava, valerian, skullcap, chamomile, or hops can ↑ CNS depression.

• PO (Adults): 15–30 mg at bedtime initially if needed; some patients may require only 7.5 mg.
• PO (Geriatric Patients): 7.5 mg at bedtime.

(Generic available)

• Capsules: 7.5 mg; 15 mg; 22.5 mg; 30 mg;

• Assess mental status (orientation, mood, behavior) and potential for abuse prior to administering medication.
• Assess risk for addiction, abuse, or misuse prior to administration and periodically during therapy.
• Assess sleep patterns before and periodically throughout therapy.
• Prolonged high-dose therapy may lead to psychological or physical dependence. Restrict amount of drug available to patient, especially if patient is depressed or suicidal or has a history of addiction.
• Geri: Assess CNS effects and risk of falls. Institute falls prevention strategies.

• If overdose occurs, flumazenil is the antidote. Do not use with patients with seizure disorder. May induce seizures.

• Do not confuse Restoril with Risperdal.
  • Supervise ambulation and transfer of patients after administration. Remove cigarettes. Side rails should be raised and call bell within reach at all times.
  • Gradually taper to discontinue or reduce the dose to reduce risk of withdrawal reactions, increased seizure frequency, and status epilepticus. If a patient develops withdrawal reactions, consider pausing taper or increasing the dose to the previous tapered dose level. Subsequently decrease the dose more slowly. Some patients may require longer tapering period (wks to >12 mo).
• PO: Administer with food if GI irritation becomes a problem.

• Instruct patient to take temazepam as directed. Teach sleep hygiene techniques (dark room, quiet, bedtime ritual, limit daytime napping, avoidance of nicotine and caffeine). If less effective after a few wk, consult health care professional; do not increase dose. Must be discontinued gradually. Do not suddenly stop taking temazepam without consulting health care professional; may cause unusual movements, responses or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Advise patient to take temazepam only if able to devote 8 hr to sleep.
• Advise patient that temazepam is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children, and in a location not accessible by others.
• May cause daytime drowsiness or dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. Geri: Instruct patient and family how to reduce falls risk at home.
• Advise patient to avoid the use of alcohol and other CNS depressants and to consult health care professional before using OTC preparations that contain antihistamines or alcohol.
• Caution patient that complex sleep-related behaviors (sleep-driving, making phone calls, preparing and eating food, having sex, sleep walking) may occur while asleep. Inform patient to notify health care professional if sleep-related behaviors, (may include sleep-driving — driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event) occur.
• Emphasize the importance of follow-up appointments to monitor progress.
• Advise females of reproductive potential to contact health care professional immediately if pregnancy is planned or suspected. Monitor infants exposed to temazepam during pregnancy or labor for several wk or more prior to delivery for signs and symptoms of withdrawal (hypoactivity, hypotonia, hypothermia, respiratory depression, apnea, feeding problems, impaired metabolic response to cold stress). Monitor infants exposed to temazepam during breastfeeding for excessive sedation, poor feeding, and poor weight gain and advise family or caregiver to seek medical attention if they notice these signs. There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including temazepam, during pregnancy. Health care providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or online at womensmentalhealth.org/pregnancyregistry/.

• Improvement in sleep pattern with decreased number of nighttime awakenings, improved sleep onset, and increased total sleep time, which may not be noticeable until the 3rd day of therapy.

Restoril

Schedule IV (C-IV)