temazepam RESTORIL
Class: Benzodiazepine/3-HydroxyFDA Indications: Insomnia
Off-Label Use: Anxiety, Periodic Limb Movement Disorder
Prescribing
FDA Schedule IVForms: 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
Precautions
Contraindications: Sleep apneaSerious 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
Pharmacokinetics
t½: 11 (8-20)° TMAX: 2-3°Absorption Rate: Medium
Lipid Solubility: Low-moderate
Substrate of: Conjugation
Inhibits: ∅ ; Induces: ∅
Active Metabolites: ∅
DDIs
- - CNS depression with combined use of opioids
- - estrogen containing oral contraceptives may accelerate its metabolism
Misc
- - 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
References
Benzodiazepine Hypnotics: Sorting The Pharmacokinetic Facts., Greenblatt DJTemazepam Package Insert
Clinical Handbook Of Psychotropic Drugs 18th Ed
Use Of Psychiatric Medications During Pregnancy And Lactation
An Updated Unified Pharmacophore Model Of The Benzodiazepine Binding Site On GABAAR
UpToDate
Neonatal Benzodiazepines Exposure During Breastfeeding