Temazepam tablets are indicated for the short-term management of insomnia, typically for a duration of 7 to 10 days. For patients with transient insomnia, prescriptions should clearly specify that Temazepam is intended for brief use only. Clinical studies supporting its effectiveness were conducted over a period of 2 weeks, with the final evaluation of sleep onset performed at the end of the treatment period.

Gamma-aminobutyric acid (GABA) is the primary inhibitory neurotransmitter in the human body. When GABA binds to GABA(A) receptors located at neuronal synapses, it facilitates the movement of chloride ions across neuronal membranes through ion channels. This influx of chloride ions leads to hyperpolarization of the neuron, making it less likely to generate action potentials and thereby reducing neuronal excitability.

Benzodiazepines such as Temazepam bind to specific benzodiazepine sites on GABA(A) receptors, enhancing the action of GABA. This interaction increases the affinity of GABA for its receptor, leading to greater chloride ion influx and further hyperpolarization of neuronal membranes. As a result, neuronal activity is suppressed, producing effects such as sedation, sleep induction (hypnosis), muscle relaxation, anticonvulsant activity, and anxiolytic effects. These receptors are present both in the central nervous system and peripheral tissues, contributing to the overall pharmacological effects of the drug.

While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Benzodiazepines may cause harm to the fetus when administered during pregnancy. Several studies have suggested an increased risk of congenital abnormalities with the use of benzodiazepines such as diazepam and chlordiazepoxide during the first trimester. Use during the later stages of pregnancy may lead to central nervous system depression in the newborn due to transplacental transfer.

Animal studies with temazepam have shown adverse reproductive effects. In rats, high oral doses resulted in increased mortality in offspring and higher rates of fetal resorption. Skeletal variations, such as rudimentary ribs, were observed at high doses. In rabbits, occasional abnormalities including brain malformations and rib anomalies were reported, although not consistently dose-related.

Temazepam is contraindicated in women who are pregnant or may become pregnant. If used during pregnancy, patients should be informed about the potential risks to the fetus. Women of childbearing age should be advised to discontinue the drug before planning pregnancy and the possibility of pregnancy should be considered before initiating therapy.

The most common adverse effects of temazepam include:

• Drowsiness
• Headache
• Fatigue
• Nervousness
• Dizziness
• Nausea

Pregnancy Category X: Temazepam is contraindicated during pregnancy. It is not known whether temazepam is excreted in human breast milk. Since many drugs are excreted in breast milk, caution should be exercised when administered to breastfeeding women.

Elderly or debilitated patients are more susceptible to excessive sedation, dizziness, confusion, and lack of coordination; therefore, a lower starting dose (7.5 mg) is recommended. Temazepam should be used cautiously in patients with severe depression or those at risk of suicidal tendencies. Careful monitoring is required in patients with impaired kidney or liver function, and in those with chronic respiratory disorders. Caution is advised when combining temazepam with other central nervous system depressants or sedative medications due to the potential for additive or synergistic effects. A possible interaction has been noted with diphenhydramine, and a case of stillbirth has been reported following combined use, although a direct causal relationship has not been established.

Benzodiazepine hypnotic and sedative

Store at room temperature between 20°C and 25°C. Keep out of reach of children.