Restoril (Temazepam) for Insomnia in Adults
For adults with chronic insomnia, temazepam should be dosed at 15-30 mg at bedtime (7.5 mg for elderly/debilitated patients), used only for short-term treatment of 7-10 days, and should be combined with cognitive behavioral therapy whenever possible. 1
Recommended Dosing
Standard adult dose: 15 mg at bedtime is the typical starting dose, though 7.5 mg may suffice for some patients and others may require 30 mg 2, 1
Elderly or debilitated patients: Initiate therapy at 7.5 mg until individual response is determined 2, 1
For transient insomnia specifically: 7.5 mg may be sufficient to improve sleep latency 1
The drug should be taken on an empty stomach to maximize effectiveness, right before getting into bed, and only when able to get a full night's sleep (at least 8 hours) 2, 1
Duration of Therapy
Temazepam is FDA-approved for short-term use only: 7-10 days 1. The clinical trials supporting efficacy were 2 weeks in duration 1. This is a critical limitation—temazepam is not intended for chronic, ongoing use despite the chronic nature of insomnia disorder.
When discontinuing or reducing dosage, use a gradual taper to reduce withdrawal risk 1. If withdrawal reactions develop, pause the taper or increase to the previous dose level, then decrease more slowly 1.
Clinical Positioning
According to the 2017 American Academy of Sleep Medicine guidelines, temazepam is suggested for treatment of both sleep onset AND sleep maintenance insomnia based on 15 mg dose trials 3. This represents a WEAK recommendation, meaning clinical judgment and patient preferences should guide use 3.
The 2008 AASM guidelines position temazepam as a first-line pharmacologic option among short-to-intermediate acting benzodiazepine receptor agonists 2. Temazepam has a relatively longer half-life compared to agents like zaleplon, making it more likely to improve sleep maintenance but also more likely to produce residual sedation (though this remains limited to a minority of patients) 2.
Contraindications and Precautions
Absolute contraindication: Allergy to temazepam or any ingredient 1
Use with extreme caution or avoid in:
- Patients taking opioids (risk of respiratory depression, excessive sedation, coma, death) 1
- Pregnancy (especially late pregnancy—risk of neonatal sedation, withdrawal symptoms) 1
- Breastfeeding (passes into breast milk causing infant sedation, feeding problems, decreased weight gain) 1
- Depression or suicidal ideation 2, 1
- Compromised respiratory function (asthma, COPD, sleep apnea) 2
- Hepatic or heart failure 2
- History of substance abuse (Schedule IV controlled substance with abuse/dependence potential) 1
Not recommended during pregnancy or nursing 2. A pregnancy registry exists for monitoring outcomes (1-866-961-2388) 1.
Critical Safety Warnings
Complex sleep behaviors: Patients may engage in activities while not fully awake (sleep-driving, sleep-eating, sleep-walking, sexual behavior) with no memory the next morning 2, 1. Risk increases with alcohol or other CNS depressants 2, 1.
Dependence and withdrawal: Physical dependence can develop even with prescribed use 1. Abrupt discontinuation can cause life-threatening withdrawal including seizures, severe mental changes, suicidal thoughts, and symptoms lasting weeks to months 1.
Abuse potential: Risk of abuse, misuse, and addiction leading to overdose, coma, and death 1. Keep medication secure and do not share 1.
Additive CNS depression: Avoid concurrent use with alcohol, other sedatives, or CNS depressants unless specifically directed 2, 1
Adverse Effects Profile
Research demonstrates temazepam has a favorable safety profile in older adults. In an 8-week study of elderly patients with chronic insomnia, adverse effects were infrequent (7.8% in temazepam group vs 10.8% in placebo), mild in severity, and decreased over time 4. A 7.5 mg dose study in elderly insomniacs found minimal CNS and behavioral adverse effects with no significant rebound insomnia upon withdrawal 5.
However, rebound insomnia can occur even with brief, intermittent use. One study showed temazepam 30 mg produced variable rebound effects, with total wake time increased 39% during the second withdrawal period 6.
Treatment Algorithm
Step 1: Initiate cognitive behavioral therapy for insomnia (CBT-I) as first-line treatment 2. Sleep hygiene alone is insufficient 2.
Step 2: If pharmacotherapy is needed, select temazepam based on:
- Symptom pattern (sleep onset vs maintenance)
- Past treatment responses
- Patient preference
- Comorbid conditions
- Cost and availability 2
Step 3: Start at 15 mg (7.5 mg if elderly/debilitated) for 7-10 days maximum 1
Step 4: If initial agent unsuccessful, switch to alternative benzodiazepine receptor agonist or ramelteon 2
Step 5: Follow patients every few weeks initially to assess effectiveness, side effects, and need for ongoing medication 2
Step 6: Employ lowest effective maintenance dose and taper when conditions allow 2
Key Clinical Pearls
Adding CBT-I to temazepam reduces medication usage (16 mg average vs 20 mg with drug alone) with comparable sleep improvements and similar adverse effect rates 4. Always combine pharmacotherapy with behavioral interventions when possible 2.
Temazepam is absorbed more slowly than other agents, so it may not consistently reduce sleep latency because blood levels don't peak quickly enough after bedtime dosing 7. This makes it particularly suited for sleep maintenance rather than sleep onset problems.
Studies up to 5 weeks show no tolerance development or REM sleep suppression (unlike other benzodiazepines), though some slow-wave sleep suppression occurs at 30 mg 8.
Patient education is mandatory and must cover: treatment goals, safety concerns, potential side effects and interactions, behavioral treatment options, dosage escalation risks, and rebound insomnia 2.