What is temazepam 30 milligram capsule?

Temazepam 30 mg Capsule

Temazepam 30 mg is a benzodiazepine hypnotic medication used to treat both sleep onset and sleep maintenance insomnia in adults, though clinical guidelines are based primarily on 15 mg dosing studies. 1

Medication Classification and Formulation

Temazepam is a 1,4-benzodiazepine with the chemical name 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one 2. The 30 mg capsule is a white opaque formulation for oral administration containing temazepam USP along with inactive ingredients including corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin, and titanium dioxide 2.

Clinical Indications and Evidence

The American Academy of Sleep Medicine (2017) suggests that clinicians use temazepam as a treatment for sleep onset and sleep maintenance insomnia versus no treatment in adults 1. However, this is a WEAK recommendation based primarily on trials using 15 mg doses, not 30 mg 1.

Key Evidence Points:

• For 15 mg dosing: Meta-analyses demonstrate clinically significant reductions in subjective sleep latency (20 minutes) and improvements in total sleep time 1
• For 30 mg dosing: Individual studies show significant efficacy for improving subjective sleep latency and total sleep time, but meta-analysis was not possible due to limited data 1
• The evidence quality is moderate overall, based on small sample sizes (19-34 subjects in primary studies) 1

Pharmacokinetics

The 30 mg dose produces peak plasma concentrations within approximately 1.7-3 hours after oral ingestion 3, 4. The elimination half-life is 10-15 hours 3, 5, making it intermediate-acting compared to other benzodiazepines. Notably, temazepam is absorbed more slowly than flurazepam but metabolized more quickly, and has no long-acting metabolites 3.

Dosing Recommendations

The manufacturer recommends 30 mg before bedtime for most adults and 15 mg for geriatric or debilitated patients 3. However, clinical guideline evidence is stronger for the 15 mg dose 1. For elderly patients specifically, doses as low as 7.5 mg have shown efficacy with minimal adverse effects 6.

Safety Profile

The 30 mg dose has the most significant effects on sedation and psychomotor impairment among tested doses 7:

• Sedation: Dose-dependent with 30 mg producing the greatest sedative effect compared to 15 mg and placebo 7
• Psychomotor impairment: Most detrimental at 30 mg compared to all other treatments (p < 0.001) 7
• Adverse effects in elderly: Generally infrequent (7.8% complaint rate), mild in severity, and decrease over time with continued use 8
• Rebound insomnia: Minimal evidence of rebound insomnia after discontinuation, particularly at lower doses 9, 6

Important Caveats:

• Observational data link benzodiazepines to dementia risk, with greatest effects for higher-dose hypnotics and drugs with half-lives exceeding 24 hours 10
• The 30 mg dose may impair next-day function more than lower doses, particularly in elderly patients 7
• Temazepam reaches peak levels too slowly to consistently reduce sleep onset latency when taken at bedtime 3

Clinical Context

While temazepam 30 mg is FDA-approved and available, the strongest clinical evidence supports using 15 mg as the standard adult dose 1. The 30 mg dose should be reserved for patients who do not respond adequately to 15 mg, with careful monitoring for increased sedation and psychomotor impairment, especially in elderly or debilitated patients.