Restoril (Temazepam) for Insomnia Management
Direct Answer
Temazepam 15 mg is recommended as a first-line benzodiazepine receptor agonist for both sleep onset and sleep maintenance insomnia, but only after initiating Cognitive Behavioral Therapy for Insomnia (CBT-I) and only for short-term use (7-10 days, maximum 2 weeks). 1, 2, 3
Treatment Algorithm
Step 1: Initiate CBT-I First (Mandatory)
All patients with chronic insomnia must receive CBT-I as initial treatment before or alongside any pharmacotherapy, as it provides superior long-term efficacy with sustained benefits up to 2 years post-treatment, whereas medications provide only temporary symptom relief. 1, 2
CBT-I core components include: 2
- Stimulus control therapy: Use bed only for sleep, leave bed if unable to sleep within 20 minutes
- Sleep restriction therapy: Limit time in bed to actual sleep time to consolidate sleep
- Cognitive restructuring: Address maladaptive thoughts about sleep
- Sleep hygiene optimization: Avoid caffeine after early afternoon, eliminate evening alcohol, avoid late exercise
Step 2: Add Temazepam When CBT-I Alone Is Insufficient
Temazepam 15 mg is the recommended dose for adults for both sleep onset and sleep maintenance insomnia. 1
Prescribe for 7-10 days only (maximum 2 weeks based on clinical trial data supporting efficacy). 1, 3
Temazepam achieves peak plasma levels at 1.2-1.6 hours after dosing, with steady-state reached by the third dose. 3
Critical Safety Warnings (FDA Black Box Equivalent)
Abuse, Dependence, and Withdrawal Risk
Temazepam carries significant risk of abuse, misuse, addiction, physical dependence, and life-threatening withdrawal reactions. 3
Never stop temazepam suddenly—abrupt discontinuation can cause seizures, severe mental/nervous system changes, suicidal thoughts, and withdrawal symptoms lasting weeks to months. 3
Physical dependence can develop even when taking temazepam as prescribed. 3
Complex Sleep Behaviors
Patients may engage in dangerous activities while not fully awake (sleep-driving, sleep-walking, sleep-eating, having sex) with no memory the next morning. 3
Stop temazepam immediately if complex sleep behaviors occur. 2, 3
Risk increases significantly when combined with alcohol or other CNS depressants. 3
Other Serious Risks
Abnormal thoughts and behavior including aggression, confusion, hallucinations, worsening depression, and suicidal thoughts. 3
Severe allergic reactions with swelling of tongue/throat and trouble breathing. 3
Do not drive or operate machinery until you know how temazepam affects you—residual drowsiness may persist the next day. 3
Position in Treatment Hierarchy
First-Line Pharmacotherapy Options (After CBT-I)
The American Academy of Sleep Medicine recommends these agents as first-line when medication is necessary: 1
For sleep onset AND maintenance:
- Temazepam 15 mg
- Eszopiclone 2-3 mg
- Zolpidem 10 mg (5 mg in elderly)
For sleep onset only:
- Zaleplon 10 mg
- Ramelteon 8 mg
Why Temazepam May Be Selected
Temazepam is specifically effective for both sleep onset and sleep maintenance, making it appropriate when both problems coexist. 1
Clinical trials showed linear dose-response improvement in total sleep time and sleep latency, with essentially absent "hangover" effects and significant reduction in early morning awakening (particularly problematic in geriatric patients). 3
REM sleep remains essentially unchanged, and no tolerance development occurred in sleep laboratory parameters with nightly use for at least 2 weeks. 3
Alternative First-Line Options to Consider
Dual Orexin Receptor Antagonists (DORAs)
DORAs (daridorexant, lemborexant, suvorexant) inhibit wakefulness rather than induce sedation and have significant advantages over benzodiazepines: 4
- No evidence of rebound insomnia or withdrawal
- Little to no abuse potential
- Daridorexant has ideal 8-hour half-life with demonstrated 12-month efficacy
DORAs should be strongly considered as safer alternatives to temazepam, especially for patients requiring longer-term treatment or those with substance abuse history. 1, 4
Low-Dose Doxepin
- Doxepin 3-6 mg is recommended for sleep maintenance insomnia, reducing wake after sleep onset by 22-23 minutes with moderate-quality evidence. 1
Special Population Considerations
Elderly Patients
Elderly patients require lower doses (though specific elderly dosing for temazepam is not explicitly stated in guidelines, general principles apply). 2
Increased risk of falls, cognitive impairment, and complex sleep behaviors in older adults. 1, 2
Consider ramelteon 8 mg or low-dose doxepin 3 mg as safer alternatives with minimal fall risk. 1
Patients with Comorbid Depression/Anxiety
- Sedating antidepressants (mirtazapine, low-dose doxepin) are preferred as they simultaneously address both mood disorder and sleep disturbance. 1, 2
Patients with Substance Abuse History
- Avoid benzodiazepines including temazepam—consider ramelteon or DORAs instead due to lower abuse potential. 1, 5
Contraindications
Allergy to temazepam or benzodiazepines. 3
Pregnancy (may cause birth defects or harm unborn baby). 3
Breastfeeding (passes through breast milk). 3
Critical Prescribing Principles
Duration and Monitoring
Use the lowest effective dose for the shortest duration possible (typically 7-10 days, maximum 2 weeks). 1, 2, 3
Reassess after 1-2 weeks to evaluate efficacy and adverse effects. 1
If insomnia persists beyond 7-10 days, evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome, circadian rhythm disorders). 1
Patient Education Requirements
Educate about treatment goals, realistic expectations, safety concerns, and potential side effects. 1
Warn about complex sleep behaviors and instruct to stop medication immediately if they occur. 2, 3
Emphasize that pharmacotherapy supplements—never replaces—CBT-I. 1, 2
Tapering When Discontinuing
Medication must be tapered when discontinuing to prevent withdrawal symptoms. 1
CBT-I facilitates successful discontinuation. 1
Common Pitfalls to Avoid
Prescribing temazepam without initiating CBT-I first or alongside—this is the most critical error, as behavioral interventions provide superior long-term outcomes. 1, 2
Continuing pharmacotherapy long-term without periodic reassessment—evidence supports only short-term use (7-10 days). 1, 3
Failing to screen for substance abuse history—benzodiazepines carry compounded abuse potential in these patients. 1, 5
Using in elderly patients without considering safer alternatives (ramelteon, low-dose doxepin, DORAs). 1, 2
Combining with alcohol or other CNS depressants—significantly increases risk of complex sleep behaviors, respiratory depression, and cognitive impairment. 3
Abrupt discontinuation—can cause life-threatening withdrawal reactions including seizures. 3
Evidence Quality Note
The American College of Physicians explicitly states there is insufficient evidence to determine the balance of benefits and harms of long-term pharmacologic treatments for chronic insomnia, with few studies evaluating medications beyond 4 weeks. 2 Temazepam clinical trials supporting efficacy were only 2 weeks in duration. 3 This underscores the critical importance of short-term use only and mandatory implementation of CBT-I for sustained benefit.