Short-term (generally 7–10 days) management of insomnia.
Decreases sleep latency, reduces early morning awakening, and improves sleep maintenance in patients with chronic insomnia; similar effects in patients with transient insomnia.
Dosage and Administration
General
Use only when able to get 7–8 hours of sleep before being active again.
Generally limit hypnotic therapy to 7–10 days.
Avoid abrupt discontinuance; after extended therapy at doses >15 mg, taper dosage gradually.
Administration
Oral Administration
Administer at bedtime.
Dosage
Adults
Insomnia
Oral
7.5–30 mg; 15 mg is the usual recommended dose. In patients with transient insomnia, 7.5 mg may be sufficient.
Special Populations
Geriatric or Debilitated Patients
Possible increased sensitivity to benzodiazepines. Initially, 7.5 mg.
Insomnia may be a manifestation of an underlying physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.
Failure of insomnia to remit after 7–10 days of treatment, worsening of insomnia, or emergence of new abnormal thinking or behavior may indicate the presence of an underlying psychiatric and/or medical condition.
Immediately evaluate any new behavioral sign or symptom.
Adverse Psychiatric Events
Abnormal thinking and behavioral changes (e.g., aggressiveness, uncharacteristic extroversion, bizarre behavior, agitation, hallucinations, depersonalization, amnesia) may occur unpredictably in patients receiving benzodiazepines.
Some adverse effects appear to be dose related; use the lowest effective dose.
Complex Sleep-related Behaviors
Potential risk of complex sleep-related behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative-hypnotic drug, with no memory of the event), making phone calls, or preparing and eating food while asleep.
Abuse Potential
Psychologic and physical dependence may occur following prolonged use.
Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.
Withdrawal Effects
Rapid dosage reduction or abrupt discontinuance may result in signs and symptoms of withdrawal (similar to barbiturates or alcohol).
Sensitivity Reactions
Potential risk of anaphylaxis and angioedema; may occur as early as with the first dose of drug.
General Precautions
Suicide
Use with caution in depressed patients; potential for suicidal tendencies. Prescribe and dispense drug in the smallest feasible quantity.
CNS Effects
Performance of activities requiring mental alertness and physical coordination may be impaired. In clinical studies, risk of residual daytime sedation and impaired psychomotor and mental performance appeared to be minimal.
Concurrent use of other CNS depressants may potentiate CNS depression. (See Specific Drugs under Interactions.)
Respiratory Effects
Use with caution in patients with compromised respiratory function.
Specific Populations
Pregnancy
Category X.
Lactation
Benzodiazaepines generally are distributed into milk; not known whether temazepam is distributed into milk.
Caution advised if used in nursing women.
Pediatric Use
Safety and efficacy not established in children <18 years of age.
Geriatric Use
Potential increased sensitivity (increased risk of oversedation, dizziness, confusion, and/or ataxia); use low initial dose and monitor closely. (See Geriatric or Debilitated Patients under Dosage and Administration.)
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