How should insomnia be managed in a patient, potentially using Restoril (temazepam)?

Restoril (Temazepam) for Insomnia Management

Initial Treatment Recommendation

Cognitive Behavioral Therapy for Insomnia (CBT-I) must be initiated before or alongside temazepam, as it provides superior long-term outcomes and is the first-line treatment for all adults with chronic insomnia. 1, 2

Temazepam should only be considered when CBT-I alone is insufficient or as short-term adjunctive therapy, not as monotherapy. 1

When Temazepam is Appropriate

Position in Treatment Algorithm

• Temazepam is a first-line pharmacologic option among short/intermediate-acting benzodiazepine receptor agonists when medication is necessary for chronic insomnia 1, 2
• It is specifically effective for both sleep onset and sleep maintenance insomnia at a dose of 15 mg 2
• Temazepam is indicated only for short-term use (7-10 days), with FDA approval for 4-5 weeks maximum 1, 3

Dosing Strategy

• Standard adult dose: 15 mg taken 30 minutes before bedtime 2, 3
• Elderly or debilitated patients: 7.5 mg initially 3, 4
• Maximum dose: 30 mg, though higher doses increase risk of adverse effects without proportional benefit 3
• Peak plasma levels occur 1.2-1.6 hours after dosing, with a half-life of 10-15 hours 3, 5

Critical Safety Warnings

Serious Risks Requiring Immediate Attention

• Complex sleep behaviors including sleep-driving, sleep-eating, and making phone calls without memory of the event can occur even at therapeutic doses 3
• Discontinue temazepam immediately if any complex sleep behavior occurs 3
• Risk of physical dependence and withdrawal seizures with prolonged use—always taper gradually using a patient-specific plan rather than abrupt discontinuation 3
• Increased fall risk particularly in elderly patients due to drowsiness and decreased consciousness 3
• Rare but serious anaphylactic reactions involving tongue, glottis, or larynx have been reported—do not rechallenge if this occurs 3

Contraindications and High-Risk Situations

• Avoid combining with opioids due to risk of fatal respiratory depression 3
• Avoid alcohol and other CNS depressants as they substantially increase risk of complex sleep behaviors 3
• Use extreme caution in depressed patients as worsening depression and suicidal thinking have been reported 3
• Pregnancy: contraindicated especially when combined with diphenhydramine (one stillbirth reported) 3

Advantages of Temazepam Over Other Benzodiazepines

• No long-acting metabolites, reducing risk of daytime impairment and drug accumulation 3, 5
• Minimal hangover effects compared to flurazepam 5, 4
• Low propensity for rebound insomnia upon discontinuation, making it suitable for intermittent use 4
• Safe in elderly when dosed appropriately (7.5 mg), with adverse effects occurring in only 7.8% of older adults 6, 4

Limitations of Temazepam

• Does NOT consistently reduce sleep latency because it is absorbed slowly and may not reach therapeutic levels quickly enough to affect sleep onset 5
• For patients with primarily sleep onset difficulty, consider zaleplon or ramelteon instead 1, 2
• Insufficient evidence from the American College of Physicians guideline due to limited RCTs meeting inclusion criteria 1

Implementation Strategy

Week 1-2: Initial Trial

• Start CBT-I components immediately (stimulus control, sleep restriction, cognitive therapy) 1, 2
• Prescribe temazepam 15 mg (or 7.5 mg if elderly) for 7-10 days only 3, 2
• Educate patient about: treatment goals, safety concerns (especially sleep-driving), potential side effects, need for behavioral therapy, and risks of long-term use 1, 3
• Monitor closely for effectiveness on total sleep time, wake after sleep onset, and daytime functioning 3

Week 2-4: Reassessment

• If insomnia persists beyond 7-10 days, evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome, psychiatric conditions) 3
• If temazepam ineffective, switch to alternative BzRA (eszopiclone, zolpidem) rather than increasing dose 1
• Continue and intensify CBT-I regardless of medication response 1

Long-Term Management

• Taper and discontinue temazepam as soon as possible using gradual dose reduction 3
• Transition to intermittent use (3 nights per week or as-needed) rather than nightly if chronic use necessary 1
• CBT-I provides sustained benefits after medication discontinuation 1, 7

Common Pitfalls to Avoid

• Never prescribe temazepam without initiating CBT-I, as behavioral interventions provide more durable effects 1, 2
• Never continue beyond 4-5 weeks without reassessment and attempt at tapering 1, 3
• Never use standard adult doses in elderly patients—always start at 7.5 mg 3, 4
• Never combine with diphenhydramine due to synergistic effects and pregnancy risks 3
• Never assume temazepam will help with sleep onset—it primarily improves sleep maintenance 5

Alternative Considerations

If temazepam is contraindicated or ineffective:

• For sleep onset only: zaleplon 10 mg or ramelteon 8 mg 2
• For sleep maintenance: eszopiclone 2-3 mg, zolpidem 10 mg (5 mg elderly), or low-dose doxepin 3-6 mg 2
• For comorbid depression/anxiety: sedating antidepressants (trazodone, mirtazapine) as second-line 1