temazepam RESTORIL

Class: Benzodiazepine/​3-Hydroxy
FDA Indications: Insomnia
Off-Label Use: Anxiety, Periodic Limb Movement Disorder
FDA Schedule IV
Forms: 7.5, 15, 22.5, 30mg capsule
Dose Range: 15-45 mg/day
Starting: 15 to 30 mg at bedtime; some patients may respond to 7.5 mg in transient insomnia
Stopping: Rebound insomnia may occur 1-2 nights after stopping; if taken for more than a few weeks, taper

NAMI drug fact sheet

Contraindications: Sleep apnea
Serious Side Effects: Overdose can result in hypotension, respiratory depression, and coma
Side Effects: sedation/somnolence, dizziness, confusion, disequilibrium, ataxia, lightheadedness, weakness/asthenia, decreased libido, dysarthria, constipation, increased appetite, weight gain
Target: GABAA: α1, α3, γ2, β3 (high); α2 (moderate)
t½: 11 (8-20)° TMAX: 2-3°
Absorption Rate: Medium
Lipid Solubility: Low-moderate
Substrate of: Conjugation
Inhibits: ∅ ; Induces:
Active Metabolites:
  • - CNS depression with combined use of opioids
  • - estrogen containing oral contraceptives may accelerate its metabolism
  • - delays but doesn't ↓ REM
  • - one the 3 L-O-T benzodiazepines that only undergoes Phase II metabolism
  • - delayed aborption may benefit patients with middle-insomnia
Special Populations

Category X—↑ risk of oral cleft by 0.01%, use just before delivery associated with floppy infant syndrome, 3rd trimester use can cause withdrawal in newborns

Low incidence of infant toxicity and AEs associated with use during breastfeeding

Recommended initial dosage is 7.5 mg

2019 BEE℞S Recommendation: Avoid. Older adults have increased sensitivity to benzodiazepines and decreased metabolism of long- acting agents; in general, all benzodiazepines increase risk of cognitive impairment, delirium, falls, fractures, and motor vehicle crashes in older adults. May be appropriate for seizure disorders, RBD, benzodiazepine withdrawal, EtOH withdrawal, severe GAD, and periprocedural anesthesia.

There are no dosage adjustments provided in the manufacturer's labeling

There are no dosage adjustments provided in the manufacturer's labeling


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Last updated February 29 2024 20:54:18. Disclaimer: This website does not provide medical advice, nor is it a substitute for clinical judgment.