TEMAZEPAM

Clinical safety rating: avoid

Positive evidence of fetus risks but benefits may outweigh risks in some cases

How it works

Positive allosteric modulator of GABA-A receptors, enhancing the effect of GABA by increasing chloride ion influx, leading to neuronal hyperpolarization and sedation.

What the body does with it

Metabolism	Hepatic via CYP3A4 and glucuronidation; major metabolites include oxazepam and temazepam glucuronide.
Excretion	Renal excretion of conjugated metabolites (primarily as glucuronide) accounts for approximately 80% of an oral dose; fecal excretion accounts for about 12%; less than 1% is excreted unchanged in urine.
Half-life	Terminal elimination half-life is 8–20 hours in healthy adults (mean ~15 hours); may be prolonged in elderly (up to 50 hours) and in hepatic impairment (up to 40 hours); clinical context: typical dosing interval is 12–24 hours.
Protein binding	96–98% bound to albumin; binding is concentration-dependent within therapeutic range.
Volume of Distribution	0.8–1.5 L/kg (mean ~1.0 L/kg); clinical meaning: moderate distribution into tissues, including brain; higher in elderly.
Bioavailability	Oral: 91–98% (well absorbed, minimal first-pass metabolism); Intramuscular: 50–70% (erratic, not recommended).
Onset of Action	Oral: 30–60 minutes (subjective sedation); Intramuscular: erratic absorption, not recommended; Intravenous: 1–3 minutes (not available in US).
Duration of Action	Oral: 3–8 hours (hypnotic effect); clinical notes: residual sedation may last longer, especially in elderly; accumulation with repeated dosing leads to prolonged effect.

Classification & Brands

Dosing & administration

10-20 mg orally at bedtime, up to 30 mg in severe insomnia.

Dosage form	CAPSULE
Renal impairment	No adjustment required; temazepam is not significantly renally eliminated.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use.
Pediatric use	Not recommended for use in children <18 years due to lack of safety and efficacy data.
Geriatric use	Initiate at 5 mg orally at bedtime; maximum 15 mg. Use with caution due to increased risk of falls, cognitive impairment, and prolonged half-life.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

CNS depressants including alcohol and opioids increase sedation risk Abrupt discontinuation can cause withdrawal symptoms.

Breastfeeding	Temazepam is excreted into breast milk in low amounts (M/P ratio approximately 0.13). Consider risk of infant sedation, especially with chronic use. Avoid breastfeeding if possible, or use lowest effective dose for shortest duration.
Teratogenic Risk	First trimester: Limited data; possible increased risk of oral clefts (odds ratio ~1.5). Second and third trimesters: Risk of floppy infant syndrome (hypotonia, respiratory depression) and neonatal withdrawal if used near term. Avoid use in pregnancy unless benefit clearly outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Concomitant use of benzodiazepines with opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate.

Side Effect Profile

Common Effects	Sedation
Serious Effects

Absolute Contraindications

["Hypersensitivity to temazepam or other benzodiazepines","Severe respiratory insufficiency","Severe hepatic impairment","Narrow-angle glaucoma","Myasthenia gravis","Pregnancy (risk of neonatal withdrawal and floppy infant syndrome)"]

Clinical Precautions

Precautions

["Risk of respiratory depression, especially with other CNS depressants","Potential for abuse and dependence; may cause withdrawal symptoms upon discontinuation","May impair cognitive and motor function; caution in elderly and debilitated patients","Concomitant use with opioids increases risk of sedation and respiratory depression"]

Clinical Tips & Counseling

Drug interactions

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