BLACK BOX WARNING
- concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death
temazepam
Brand: Restoril
⚠ BBW Beers Criteria Prototype: diazepam
Drug Class: benzodiazepine
Drug Family: benzodiazepine
Subclass: intermediate-acting benzodiazepine hypnotic
Organ Systems: cns
Mechanism of Action
Benzodiazepine GABA-A receptor positive allosteric modulator that enhances chloride conductance; used specifically as a hypnotic for short-term management of insomnia. Intermediate half-life minimizes morning sedation compared to long-acting benzodiazepines.
GABA-A receptor (benzodiazepine site)
Indications
- short-term treatment of insomnia
Contraindications
- sleep apnea
- severe hepatic impairment
- concurrent opioids (relative)
- pregnancy
Adverse Effects
Common
- drowsiness
- dizziness
- hangover effect
- anterograde amnesia
- rebound insomnia on discontinuation
Serious
- respiratory depression
- paradoxical excitement
- dependence and withdrawal
- complex sleep behaviors (sleepwalking, sleep-driving — rare)
Pharmacokinetics (ADME)
| Absorption | oral; well absorbed; bioavailability ~96% |
| Distribution | 96% protein bound |
| Metabolism | hepatic glucuronidation (NOT CYP); no active metabolites |
| Excretion | renal |
| Half-life | 8–25 hours |
| Onset | 30 minutes |
| Peak | 1–2 hours |
| Duration | 6–8 hours |
| Protein Binding | 96% |
| Vd | 1.4 L/kg |
Drug Interactions
| Drug / Agent | Mechanism | Severity |
|---|---|---|
| opioids | additive CNS and respiratory depression | major |
| alcohol and CNS depressants | additive CNS depression | major |
Nursing Considerations
- Administer 30 minutes before bedtime; ensure patient has 7–8 hours available for sleep to minimize morning sedation.
- Beers Criteria medication in elderly: avoid in all but carefully considered situations; fall risk is significant.
- Limit to short-term use (7–10 days); rebound insomnia occurs on discontinuation.
- Unlike most benzodiazepines, temazepam is glucuronidated (not CYP450 metabolized), making it less susceptible to CYP drug interactions.
Clinical Pearls
- Temazepam's glucuronidation metabolism (avoiding CYP450) means it has fewer pharmacokinetic drug interactions than other benzodiazepines; it is preferred in elderly patients who require benzodiazepine hypnosis (if use cannot be avoided).
- However, as a Beers Criteria medication in elderly, temazepam still significantly increases fall and fracture risk; non-pharmacological insomnia treatment (CBT-I) should be first-line in older adults.
Safety Profile
Pregnancy avoid
Lactation avoid
Renal Adjustment Not required
Hepatic Adjustment Required
TDM Not required
Concordance Terms
Cross-referenced clinical concepts — click any term to see all content where it appears.