TEMAZ

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TEMAZ (TEMAZ).

How it works

Temazepam, a benzodiazepine, enhances the effect of gamma-aminobutyric acid (GABA) at the GABA-A receptor, increasing chloride ion conductance and causing neuronal hyperpolarization, leading to anxiolytic, sedative, and hypnotic effects.

What the body does with it

Metabolism	Hepatic via demethylation and hydroxylation; primarily metabolized by CYP3A4 to temazepam glucuronide (inactive), with minor contributions from CYP2C9, CYP2C19, and CYP2B6.
Excretion	Renal: ~80% as unchanged drug and metabolites; biliary/fecal: ~20%.
Half-life	Terminal elimination half-life: 1.5–2 hours; in severe renal impairment (CrCl <30 mL/min), half-life may extend to 4–6 hours, requiring dose adjustment.
Protein binding	~85% bound primarily to albumin.
Volume of Distribution	Vd: approximately 0.4–0.6 L/kg, indicating moderate tissue distribution.
Bioavailability	Oral: approximately 90% (well absorbed with limited first-pass metabolism); intramuscular: nearly 100%.
Onset of Action	Intravenous: 5–10 minutes; intramuscular: 10–20 minutes; oral: 30–60 minutes.
Duration of Action	Intravenous: 4–6 hours; intramuscular: 6–8 hours; oral: 6–8 hours; clinical effect parallels plasma concentration due to short half-life.

Classification & Brands

Dosing & administration

Temazepam 15-30 mg orally at bedtime, up to 60 mg if needed.

Dosage form	CAPSULE
Renal impairment	GFR 10-50 mL/min: use with caution; no specific dose adjustment. GFR <10 mL/min: avoid use.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated.
Pediatric use	Not recommended for children under 18 years due to lack of safety and efficacy data.
Geriatric use	Elderly patients: initial dose 7.5 mg orally at bedtime, increase cautiously; maximum 15 mg. Increased risk of falls and cognitive impairment.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TEMAZ (TEMAZ).

Breastfeeding	Unknown if excreted in human milk. Caution advised. M/P ratio not available. Consider risk of infant sedation.
Teratogenic Risk	FDA Pregnancy Category N (not classified). No adequate human studies; animal studies not available. Risk cannot be excluded. Use only if benefit outweighs risk. First trimester: unknown risk. Second/third trimester: unknown risk. May cause fetal respiratory depression if used near term.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Concomitant use 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

Serious Effects

Absolute Contraindications

Hypersensitivity to temazepam or any benzodiazepine; severe hepatic impairment; pregnancy (particularly first trimester); breastfeeding; narrow-angle glaucoma; myasthenia gravis; concurrent use of opioids (unless carefully evaluated).

Clinical Precautions

Precautions

Risk of dependence, tolerance, and withdrawal; CNS depression (avoid with alcohol or other depressants); severe anaphylactoid reactions; complex sleep behaviors (e.g., sleep-driving); respiratory depression, especially in patients with compromised respiratory function; elderly patients at increased risk for falls and cognitive impairment.

Clinical Tips & Counseling

Drug interactions

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TEMAZ

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TEMAZ (TEMAZ).

How it works

What the body does with it

Metabolism	Hepatic via demethylation and hydroxylation; primarily metabolized by CYP3A4 to temazepam glucuronide (inactive), with minor contributions from CYP2C9, CYP2C19, and CYP2B6.
Excretion	Renal: ~80% as unchanged drug and metabolites; biliary/fecal: ~20%.
Half-life	Terminal elimination half-life: 1.5–2 hours; in severe renal impairment (CrCl <30 mL/min), half-life may extend to 4–6 hours, requiring dose adjustment.
Protein binding	~85% bound primarily to albumin.
Volume of Distribution	Vd: approximately 0.4–0.6 L/kg, indicating moderate tissue distribution.
Bioavailability	Oral: approximately 90% (well absorbed with limited first-pass metabolism); intramuscular: nearly 100%.
Onset of Action	Intravenous: 5–10 minutes; intramuscular: 10–20 minutes; oral: 30–60 minutes.
Duration of Action	Intravenous: 4–6 hours; intramuscular: 6–8 hours; oral: 6–8 hours; clinical effect parallels plasma concentration due to short half-life.

Classification & Brands

Dosing & administration

Temazepam 15-30 mg orally at bedtime, up to 60 mg if needed.

Dosage form	CAPSULE
Renal impairment	GFR 10-50 mL/min: use with caution; no specific dose adjustment. GFR <10 mL/min: avoid use.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated.
Pediatric use	Not recommended for children under 18 years due to lack of safety and efficacy data.
Geriatric use	Elderly patients: initial dose 7.5 mg orally at bedtime, increase cautiously; maximum 15 mg. Increased risk of falls and cognitive impairment.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TEMAZ (TEMAZ).

Breastfeeding	Unknown if excreted in human milk. Caution advised. M/P ratio not available. Consider risk of infant sedation.
Teratogenic Risk	FDA Pregnancy Category N (not classified). No adequate human studies; animal studies not available. Risk cannot be excluded. Use only if benefit outweighs risk. First trimester: unknown risk. Second/third trimester: unknown risk. May cause fetal respiratory depression if used near term.
Fetal Monitoring