What is the recommended dosing, duration, contraindications, and side‑effect profile of Restoril (temazepam) for short‑term treatment of insomnia in otherwise healthy adults?

Restoril (Temazepam) for Short‑Term Insomnia Treatment

Recommended Dosing

The standard adult dose of temazepam is 15 mg taken 30 minutes before bedtime, with at least 7–8 hours available for sleep. 1

• For elderly or debilitated patients, initiate therapy at 7.5 mg until individual response is determined, as this population exhibits heightened sensitivity to benzodiazepines and increased fall risk. 1

• Some patients may require 30 mg if the 15 mg dose is insufficient after 1–2 weeks, though this higher dose increases the risk of next‑day psychomotor and cognitive impairment. 1

• For transient insomnia (e.g., "first night" effect), a 7.5 mg dose is sufficient to improve sleep latency and total sleep time without excessive sedation. 2

Duration of Treatment

Temazepam is FDA‑approved for short‑term use, typically 7–10 days, and should not routinely exceed 2 weeks. 1

• The American Academy of Sleep Medicine guidelines emphasize that hypnotics are intended for acute insomnia management, not chronic use, and evidence beyond 4 weeks is limited. 3

• If insomnia persists beyond 7–10 days despite temazepam, evaluate for underlying sleep disorders such as obstructive sleep apnea, restless‑legs syndrome, or circadian‑rhythm abnormalities. 1

• Discontinuation requires a gradual taper (e.g., reduce by 25% every 1–2 weeks) to prevent withdrawal reactions including rebound insomnia, seizures, anxiety, and hallucinations. 1

Contraindications

Temazepam is contraindicated in patients with known hypersensitivity to benzodiazepines or any formulation component. 1

• Avoid in patients with a history of substance use disorder, as temazepam is a Schedule IV controlled substance with significant abuse, misuse, and addiction potential. 1

• Use extreme caution in patients with respiratory compromise (e.g., COPD, sleep apnea), as benzodiazepines can depress respiratory drive and worsen hypoxemia. 1

• Pregnancy and breastfeeding are relative contraindications; temazepam may cause birth defects or harm the fetus, and it passes into breast milk. 1

• Patients with severe hepatic impairment require dose reduction (maximum 7.5 mg), as temazepam clearance is significantly reduced. 1

Side‑Effect Profile

The most common adverse effects of temazepam include drowsiness (residual morning sedation), headache, dizziness, nervousness, tiredness, and nausea. 1

• Complex sleep behaviors—including sleep‑driving, sleep‑walking, and sleep‑eating—are FDA black‑box warnings for all benzodiazepine receptor agonists; these occur more frequently when temazepam is combined with alcohol or other CNS depressants. Discontinue temazepam immediately if such behaviors are identified. 1

• Next‑day psychomotor impairment and driving impairment are common, particularly with the 30 mg dose, and patients often do not perceive the degree of impairment. 1

• Falls, fractures, and cognitive decline are increased in older adults (≥65 years) receiving temazepam, even at the 7.5 mg dose. 1, 4

• Physical dependence develops with regular use, and abrupt discontinuation precipitates withdrawal symptoms including seizures, delirium tremens, rebound anxiety, and suicidal ideation. 1

• Observational data suggest a possible association between chronic benzodiazepine use and dementia, though causality remains unproven. 3

• In controlled trials of elderly insomniacs receiving temazepam 7.5–30 mg over 8 weeks, the incidence of adverse effects was low (7.8%), with mild severity that decreased over time; however, these studies excluded patients with significant comorbidities. 4, 5

Efficacy Data

Temazepam 15 mg significantly reduces subjective sleep‑onset latency by approximately 20 minutes and increases total sleep time by 26–32 minutes compared with placebo. 3

• Objective polysomnography data show improvements in sleep efficiency, total sleep time, and wake after sleep onset, though the effect on objective sleep‑onset latency is inconsistent. 3, 6

• Temazepam 30 mg produces greater reductions in sleep‑onset latency (40–45 minutes) and total sleep time gains, but at the cost of increased next‑day sedation and cognitive impairment. 3

• Temazepam 7.5 mg is effective in elderly insomniacs, reducing total wake time from 145 to 100 minutes during short‑term use, with minimal rebound insomnia upon withdrawal. 5

• Tolerance to hypnotic effects does not develop over 35 consecutive nights of temazepam 30 mg use in small studies, though long‑term data are lacking. 7

Critical Safety Warnings

Temazepam carries FDA black‑box warnings for abuse, misuse, addiction, physical dependence, and life‑threatening withdrawal reactions. 1

• Do not combine temazepam with alcohol or other CNS depressants (opioids, other benzodiazepines, Z‑drugs), as this markedly increases the risk of respiratory depression, complex sleep behaviors, and overdose death. 1

• Patients must have at least 7–8 hours available for sleep before taking temazepam; taking it with insufficient sleep time increases the risk of next‑day impairment and complex behaviors. 1

• Screen for suicidal ideation, depression, and behavioral changes at every visit, as benzodiazepines can worsen depression and precipitate suicidal thoughts. 1

• Severe allergic reactions (angioedema, anaphylaxis) have been reported; discontinue immediately if swelling of the tongue or throat, trouble breathing, or nausea and vomiting occur. 1

Integration with Behavioral Therapy

Cognitive Behavioral Therapy for Insomnia (CBT‑I) must be initiated before or alongside temazepam, as behavioral therapy provides superior long‑term efficacy and sustained benefits after medication discontinuation. 3, 8

• CBT‑I includes stimulus control, sleep restriction, relaxation techniques, and cognitive restructuring, and can be delivered via individual, group, telephone, web‑based, or self‑help formats. 8

• Combining temazepam with CBT‑I reduces the total dose of medication required (average 16 mg vs. 20 mg for temazepam alone) and facilitates successful tapering. 4

Common Pitfalls to Avoid

• Using temazepam as first‑line therapy without attempting CBT‑I leads to medication dependence and less durable benefit. 3, 8

• Prescribing adult doses (15–30 mg) to elderly patients without starting at 7.5 mg increases fall and fracture risk. 1

• Continuing temazepam beyond 2 weeks without reassessment violates FDA labeling and increases the risk of dependence and tolerance. 1

• Failing to taper gradually upon discontinuation precipitates severe withdrawal reactions including seizures and delirium. 1

• Combining temazepam with other sedatives (e.g., alcohol, opioids, other benzodiazepines) creates dangerous polypharmacy with additive CNS depression. 1