What is Restoril (temazepam)?

What is Restoril (Temazepam)?

Restoril (temazepam) is a benzodiazepine hypnotic medication FDA-approved for the short-term treatment of insomnia (typically 7-10 days), specifically targeting sleep maintenance problems and increasing total sleep time. 1

Drug Classification and Mechanism

• Temazepam is a Schedule IV controlled substance that works as a benzodiazepine receptor agonist, acting on GABA receptors in the central nervous system 2, 1
• The chemical structure is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, making it a 1,4-benzodiazepine derivative 1, 3

Pharmacokinetic Profile

Temazepam has a short-to-intermediate duration of action with distinct absorption characteristics:

• Peak plasma concentrations occur within 2-3 hours after oral administration (slower than most other hypnotics) 3, 4
• Elimination half-life ranges from 10-15 hours (mean 14.7 hours), which is shorter than flurazepam but longer than ultra-short-acting agents 3, 4
• No clinically significant active metabolites, distinguishing it from longer-acting benzodiazepines like flurazepam 5, 2

Clinical Indications and Efficacy

The American Academy of Sleep Medicine suggests using temazepam for both sleep onset and sleep maintenance insomnia, though the evidence is stronger for sleep maintenance:

• Most effective for reducing nighttime awakenings and increasing total sleep time 2
• Less consistent evidence for reducing sleep latency due to delayed absorption when taken at bedtime 3, 2
• Demonstrated efficacy at 15 mg dose with clinically significant reductions in subjective sleep latency (20 minutes) and improvements in total sleep time 2

Dosing Recommendations

Standard dosing from FDA labeling and clinical guidelines:

• Adults: 15-30 mg at bedtime 2
• Elderly or debilitated patients: 7.5 mg at bedtime (lower starting dose due to increased sensitivity) 2, 6
• Take only when able to get a full night's sleep (7-8 hours) before needing to be active 1
• Administer on an empty stomach to maximize effectiveness 2

Available Formulations

Temazepam capsules are available in four strengths: 7.5 mg, 15 mg, 22.5 mg, and 30 mg 1

Serious Safety Warnings

The FDA requires prominent warnings about three critical risks:

1. Abuse, Misuse, and Addiction

• Risk of developing addiction even when taken as prescribed 1
• Can lead to overdose, coma, and death 1
• Must be kept in a safe place away from others; sharing or selling is illegal 1

2. Physical Dependence and Withdrawal

• Abrupt discontinuation can cause life-threatening withdrawal symptoms including seizures, severe mental status changes, and suicidal thoughts 1
• Withdrawal symptoms can persist for weeks to over 12 months 1
• Requires gradual tapering under medical supervision 1

3. Complex Sleep Behaviors

• Patients may engage in activities while not fully awake (sleep-driving, sleep-eating, sleep-walking) with no memory of the event 1
• Risk increases with alcohol or other CNS depressants 1

Common Adverse Effects

The most frequently reported side effects include:

• Drowsiness and residual next-day sedation (though less than longer-acting agents) 1, 5
• Headache 1
• Dizziness 1
• Nervousness 1
• Memory and performance impairment 2
• Falls (particularly in elderly patients) 2

Contraindications and Precautions

Do not use temazepam in patients with:

• Known hypersensitivity to temazepam or benzodiazepines 1

Use with extreme caution in:

• Pregnancy (may cause birth defects or harm to fetus) 1
• Breastfeeding (passes into breast milk) 1
• Depression or suicidal ideation 1
• History of substance abuse 1
• Respiratory compromise (asthma, COPD, sleep apnea) 2
• Hepatic impairment 2
• Elderly patients (require dose reduction and increased monitoring for falls) 2

Drug Interactions

• Avoid concurrent use with alcohol or other CNS depressants (can cause severe sedation, respiratory depression, and death) 1, 2
• Additive psychomotor impairment with other sedating medications 2

Clinical Positioning

According to American Academy of Sleep Medicine guidelines, temazepam is positioned as:

• A first-line pharmacologic option among short/intermediate-acting benzodiazepine receptor agonists for insomnia 2
• Particularly appropriate for patients with sleep maintenance complaints due to its longer half-life compared to ultra-short-acting agents like zaleplon 2
• May produce more residual sedation than ultra-short-acting agents but less than long-acting benzodiazepines like flurazepam 2
• Not recommended as first-line for patients with substance use disorders (consider ramelteon instead) 2

Duration of Therapy

Temazepam is approved only for short-term use:

• Typical treatment duration is 7-10 days 1
• Safety and efficacy beyond 2 weeks has not been established 1
• Failure to improve after 7-10 days suggests the need to re-evaluate for underlying psychiatric or medical conditions 2

Comparative Considerations

Temazepam differs from other benzodiazepine hypnotics:

• Slower absorption than zolpidem or triazolam, making it less ideal for pure sleep-onset insomnia 3, 2
• Shorter duration than flurazepam, with lower risk of daytime accumulation and hangover 3, 5
• No active metabolites unlike diazepam or flurazepam, reducing risk of prolonged effects 5, 2
• Lower propensity for rebound insomnia compared to ultra-short-acting agents like triazolam 6