What is the recommended use and precautions for Temazepam (Restoril) 15 MG Capsule in treating insomnia?

Temazepam 15 MG Capsule for Insomnia

The American Academy of Sleep Medicine recommends temazepam 15 mg as an effective treatment for both sleep onset and sleep maintenance insomnia in adults, taken 15-30 minutes before bedtime for short-term use (7-10 days). 1, 2

Recommended Use

Indication and Dosing

• Temazepam 15 mg is the evidence-based dose for treating chronic insomnia, specifically targeting both difficulty falling asleep and staying asleep 1
• The FDA approves temazepam for short-term treatment of insomnia, generally 7-10 days 2
• Take 15 mg orally 15-30 minutes before bedtime 2
• For elderly or debilitated patients, initiate therapy at 7.5 mg until individual response is determined 2
• Some patients may require 30 mg, though the 15 mg dose has the strongest evidence base 1

Clinical Efficacy

• Temazepam 15 mg reduces sleep latency by approximately 20 minutes compared to placebo 1
• Increases total sleep time by clinically significant amounts 1
• Reduces wake after sleep onset (WASO) based on objective polysomnographic data 1
• Improves sleep efficiency in both subjective patient reports and objective measurements 1

Important Precautions and Warnings

Duration of Use

• Limit use to short-term periods (7-10 days) as recommended by the FDA 2
• The clinical trials supporting efficacy were only 2 weeks in duration 2
• Long-term use can lead to tolerance development, diminishing effectiveness 3
• After 7-10 days without improvement, reevaluate for underlying sleep disorders rather than continuing medication 4

Discontinuation Protocol

• Never stop abruptly—use gradual tapering to prevent withdrawal reactions 2
• If withdrawal symptoms develop, pause the taper or increase back to the previous dose level 2
• Subsequently decrease more slowly 2
• Temazepam has low propensity for rebound insomnia compared to other benzodiazepines 5

Special Populations

• Elderly patients: Start at 7.5 mg due to increased sensitivity to side effects 2
• Elderly patients have higher risk of falls, cognitive impairment, and complex sleep behaviors 3
• Debilitated patients also require initial dosing at 7.5 mg 2

Adverse Effects and Safety

• Minimal treatment-emergent adverse events reported in clinical trials 1
• Common side effects include drowsiness, dizziness, and lethargy 6
• Low incidence of hangover effects at 15 mg dose 6
• Combining with other sedative medications (benzodiazepines, Z-drugs, sedating antidepressants) significantly increases risk of complex sleep behaviors, cognitive impairment, and falls 3

Clinical Decision Algorithm

When to Use Temazepam 15 mg

• Patient has documented sleep onset insomnia (difficulty falling asleep) 1
• Patient has sleep maintenance insomnia (difficulty staying asleep) 1
• Short-term situational insomnia requiring pharmacologic intervention 2
• Patient has failed or cannot access Cognitive Behavioral Therapy for Insomnia (CBT-I) as first-line treatment 3, 7

When NOT to Use or When to Reassess

• If insomnia persists beyond 7-10 days of treatment, evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome) rather than continuing medication 3, 4
• Patient already taking multiple GABA-ergic medications (indicates tolerance) 3
• Patient has history of substance abuse (benzodiazepines carry dependence risk) 2
• Elderly patient without trial of lower 7.5 mg dose first 2

Integration with Non-Pharmacologic Treatment

• CBT-I should be the foundation of insomnia treatment, with temazepam used as adjunctive short-term therapy 3, 7
• CBT-I provides sustainable improvement without tolerance issues 3
• Reassess need for pharmacotherapy after 8-12 weeks of CBT-I 3

Common Pitfalls to Avoid

• Do not prescribe for longer than 7-10 days without reassessing for underlying causes 2
• Do not combine with other benzodiazepines or multiple sedative-hypnotics (increases adverse event risk without additional benefit) 3
• Do not use standard adult dosing in elderly patients without first trying 7.5 mg 2
• Do not abruptly discontinue after regular use (causes withdrawal and rebound insomnia) 2
• Do not continue prescribing if patient develops tolerance (switch to different mechanism of action like low-dose doxepin 3-6 mg or ramelteon 8 mg) 3, 4

Monitoring and Follow-Up

• Follow-up every 2-4 weeks initially to assess treatment response 3, 7
• Monitor for signs of tolerance (requiring higher doses for same effect) 3
• Assess for daytime sedation, cognitive impairment, or falls, especially in elderly 3
• Evaluate medication tapering progress if discontinuing 3