Is Restoril (temazepam) effective for treating insomnia?

Restoril (Temazepam) Effectiveness for Sleep Aid

Evidence is insufficient to recommend temazepam as a first-line treatment for insomnia, and cognitive behavioral therapy for insomnia (CBT-I) should be prioritized instead. 1

Evidence Quality and Guideline Recommendations

The American College of Physicians conducted a comprehensive systematic review and explicitly states there is insufficient evidence on the effectiveness of benzodiazepine hypnotics including temazepam for treating chronic insomnia disorder in both general and older adult populations. 1 This represents the highest quality guideline evidence available (2016, Annals of Internal Medicine), and despite temazepam being widely used, it was not addressed in detail because few studies met rigorous inclusion criteria. 1

First-Line Treatment Recommendation

CBT-I provides superior value and should be the initial treatment approach for chronic insomnia before considering any pharmacologic therapy. 1 The evidence shows CBT-I is effective in both general adult populations and older adults, with sustained long-term benefits and minimal risk of adverse effects compared to medications. 1

When Pharmacotherapy Is Necessary

If medication becomes necessary after CBT-I fails or as adjunctive therapy, the American Academy of Sleep Medicine recommends the following hierarchy:

First-Line Pharmacologic Options (NOT Temazepam):

• Short-intermediate acting benzodiazepine receptor agonists (Z-drugs): Zolpidem (10 mg, 5 mg in elderly), eszopiclone (2-3 mg), or zaleplon (10 mg) 2, 3
• Ramelteon (8 mg): Particularly suitable for patients with substance use history due to no DEA scheduling and no dependence potential 2, 3

Second-Line Options (Where Temazepam Appears):

Temazepam (15 mg) is suggested only as a second-line option for both sleep onset and sleep maintenance insomnia when first-line agents have failed. 2 The American Academy of Sleep Medicine places it after Z-drugs and ramelteon in the treatment algorithm. 2

Temazepam-Specific Evidence

FDA-Approved Indication:

Temazepam is FDA-approved only for short-term treatment of insomnia (7-10 days), with clinical trial support extending to 2 weeks maximum. 4 The FDA explicitly states prescriptions should indicate use for short periods only. 4

Pharmacokinetic Profile:

• Peak plasma levels occur 1.2-1.6 hours after dosing 4
• Half-life of 10-15 hours (longer in elderly) 5, 6
• Intermediate duration of action with no active metabolites 4, 6
• Slower absorption than other benzodiazepines, which may explain inconsistent effects on sleep onset 5, 6

Clinical Efficacy Data:

Research studies show temazepam reduces nighttime awakenings and increases total sleep time, but evidence for reducing sleep latency (time to fall asleep) is inconsistent. 7, 5, 6 In elderly insomniacs, 7.5 mg temazepam improved total wake time from 145 to 100 minutes with short-term use, though this effect diminished with continued administration. 7

Critical Safety Concerns

Serious Adverse Effects:

The FDA label carries black box warnings for: 4

• Risk of abuse, misuse, and addiction leading to overdose, coma, and death 4
• Physical dependence and withdrawal reactions that can be life-threatening if stopped abruptly 4
• Complex sleep behaviors including sleep-driving, sleep-eating, and other activities without full awareness 4

Observational Study Findings:

Despite limited adverse event reporting in controlled trials, observational studies demonstrate hypnotic drugs including benzodiazepines are associated with dementia, serious injury, and fractures, particularly in older adults. 1 The FDA recommends lower dosages than those used in many clinical studies, especially for elderly patients. 1

Adverse Event Profile in Clinical Use:

An 8-week study in older adults found temazepam had a low incidence of adverse effects (7.8%), with mild severity that decreased over time. 8 However, 10 of 20 patients reached the maximum 30 mg dose, suggesting tolerance development. 8 When combined with CBT, patients used less medication (16 mg average vs 20 mg) with comparable sleep improvements. 8

Duration of Use Limitations

The FDA has approved pharmacologic therapy for short-term use only (4-5 weeks), and patients should not continue using these drugs for extended periods. 1 Long-term adverse effects remain unknown because few studies evaluated medications beyond 4 weeks. 1 The FDA recommends that insomnia not remitting within 7-10 days of treatment warrants further evaluation for underlying conditions. 1

Clinical Algorithm for Insomnia Treatment

Step 1: Initial Approach

• Implement CBT-I as first-line therapy for all patients with chronic insomnia 1, 2
• CBT-I components include stimulus control, sleep restriction, relaxation techniques, and cognitive restructuring 2, 3

Step 2: If CBT-I Insufficient or Unavailable

• Consider Z-drugs (zolpidem, eszopiclone, zaleplon) or ramelteon as first-line pharmacotherapy 2, 3
• Match medication to symptom pattern: zaleplon/ramelteon for sleep onset only; eszopiclone/zolpidem for maintenance 2, 3

Step 3: If First-Line Medications Fail

• Trial alternative Z-drug or ramelteon not yet attempted 2
• Consider temazepam (15 mg) as second-line benzodiazepine option 2
• Evaluate for low-dose doxepin (3-6 mg) specifically for sleep maintenance 2, 3

Step 4: Special Populations

• Elderly patients: Use lowest effective dose (temazepam 7.5-15 mg if prescribed), monitor for falls and cognitive impairment 1, 7, 8
• Substance use history: Strongly prefer ramelteon or suvorexant over any benzodiazepine including temazepam 3
• Comorbid depression/anxiety: Consider sedating antidepressants (doxepin, mirtazapine) rather than benzodiazepines 1, 2

Common Pitfalls to Avoid

• Do not use temazepam as first-line therapy when superior alternatives with better evidence exist 1, 2
• Do not prescribe for longer than 2-4 weeks without reassessment and attempt at discontinuation 1, 4
• Do not abruptly discontinue after regular use; taper gradually to prevent withdrawal seizures and severe psychiatric symptoms 4
• Do not combine with alcohol or other CNS depressants due to enhanced sedation and respiratory depression risk 4
• Do not ignore the need for CBT-I even when using medication; combined therapy allows lower medication doses 8
• Do not prescribe without educating patients about complex sleep behaviors, fall risk, and signs of dependence 4

Comparative Effectiveness Gap

There is insufficient evidence to directly compare temazepam with other pharmacologic treatments or with CBT-I. 1 The lack of head-to-head trials means the relative positioning of temazepam versus Z-drugs relies on indirect evidence and safety profiles rather than direct efficacy comparisons. 1