How should Restoril (temazepam) be dosed, limited in duration, and tapered for an otherwise healthy adult with insomnia, and what are its contraindications and major adverse effects?

Restoril (Temazepam) for Insomnia: Dosing, Duration, Tapering, and Safety

Dosing Recommendations

Start with 15 mg at bedtime for most adults, taken only when able to get a full 7–8 hours of sleep before needing to be active. 1, 2

• For elderly or debilitated patients, initiate therapy at 7.5 mg and titrate based on individual response; maximum dose should not exceed 15 mg in this population. 1, 2
• Some patients may require 30 mg, though this higher dose increases risk of adverse effects without proportional benefit in many cases. 2, 3
• For transient insomnia, 7.5 mg may be sufficient to improve sleep latency and total sleep time. 2, 4

Duration of Use and Tapering

Temazepam should be reserved for short-term use only (7–10 days, maximum 2 weeks) due to significant risks of dependence, withdrawal, complex sleep behaviors, and lack of long-term safety data. 1

Tapering Protocol

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage using a patient-specific plan. 2

• Reduce the dose by approximately 25% every 1–2 weeks while monitoring closely for withdrawal symptoms. 5
• If withdrawal reactions develop (rebound insomnia, anxiety, seizures), pause the taper or increase the dosage to the previous level, then decrease more slowly. 2
• Abrupt discontinuation can precipitate life-threatening acute withdrawal reactions, including seizures. 2
• Some patients may develop protracted withdrawal syndrome with symptoms lasting weeks to more than 12 months. 2

Contraindications and High-Risk Populations

Absolute Contraindications

Do not prescribe temazepam to patients concurrently using opioid analgesics due to markedly increased risk of respiratory depression and death. 2

Relative Contraindications and Cautions

• Patients with substance use disorder history: Temazepam carries significant abuse, misuse, and addiction potential; consider ramelteon 8 mg or suvorexant instead. 5, 1, 2
• Elderly patients (≥65 years): Substantially higher risk for falls, fractures, cognitive impairment, and complex sleep behaviors; start at 7.5 mg maximum. 1, 2
• Hepatic impairment: Reduced clearance necessitates lower doses. 1
• Respiratory disorders (sleep apnea, COPD): Benzodiazepines cause respiratory depression; avoid or use extreme caution. 5

Major Adverse Effects

Common Side Effects

• Drowsiness, dizziness, and lethargy are the most frequently reported adverse effects. 6
• In elderly patients with chronic insomnia, adverse effects occur infrequently (7.8% incidence) and are typically mild, decreasing over the course of treatment. 7
• Daytime sedation and hangover effects are relatively low at 15 mg and 7.5 mg doses. 6

Serious Adverse Effects

Complex sleep behaviors (sleep-driving, sleep-walking, sleep-eating) can occur even at therapeutic doses, particularly when combined with alcohol or other CNS depressants. 1, 2

• Discontinue temazepam immediately if any complex sleep behavior is reported. 2
• Behavioral changes including decreased inhibition, aggressiveness, bizarre behavior, agitation, hallucinations, and depersonalization may occur. 2
• Cognitive impairment and memory problems can develop, especially in elderly patients. 1
• Falls and fractures are significantly increased in older adults. 1

Drug Interactions

Concomitant use with opioids increases the risk of drug-related mortality compared to opioid use alone. 2

• If co-prescription is unavoidable, prescribe the lowest effective dosages and minimum durations, and follow patients closely for respiratory depression and sedation. 2
• Avoid or minimize concomitant use of other CNS depressants (alcohol, other sedatives, antihistamines) as they increase the risk of complex sleep behaviors and respiratory depression. 2

Essential Treatment Framework

All pharmacotherapy with temazepam must be supplemented with Cognitive Behavioral Therapy for Insomnia (CBT-I), which demonstrates superior long-term outcomes with sustained benefits after medication discontinuation. 5, 1

• CBT-I includes stimulus control therapy, sleep restriction therapy, relaxation techniques, and cognitive restructuring. 5, 1
• Temazepam should only be used after CBT-I has been initiated, not as first-line monotherapy. 1

Monitoring Requirements

Reassess after 1–2 weeks to evaluate efficacy on sleep latency, total sleep time, nocturnal awakenings, and daytime functioning. 5

• If insomnia persists beyond 7–10 days despite treatment, evaluate for underlying sleep disorders (sleep apnea, restless legs syndrome, periodic limb movement disorder). 5, 2
• Screen for complex sleep behaviors, falls, cognitive impairment, and signs of abuse or dependence at every visit. 5, 1

Common Pitfalls to Avoid

• Using temazepam as first-line treatment without initiating CBT-I bypasses the standard of care. 1
• Prescribing standard adult doses (30 mg) to elderly patients rather than starting with 7.5–15 mg increases fall and cognitive impairment risk. 1
• Continuing pharmacotherapy long-term without periodic reassessment contradicts FDA labeling and guideline recommendations for short-term use only. 5, 1
• Combining temazepam with opioids or multiple CNS depressants creates dangerous polypharmacy with potentially fatal respiratory depression. 2