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temazepam

Adjunctive therapy

Brand: RESTORIL

Published 2026-02-13 · Last reviewed 2026-02-20 · 5 references

Content sourced from FDA labeling (DailyMed) and peer-reviewed literature.

Print sheet Review evidence

At a glance

Class: Adjunctive therapy·Typical dose: Usual adult dose: 15 mg at bedtime; some may require 30 mg (label).·Half-life: Single-dose mean 8.8 h; Single-dose range 3.5–18.4 h·LAI available: No

Class: Adjunctive therapy
Typical dose: Usual adult dose: 15 mg at bedtime; some may require 30 mg (label).
Half-life: Single-dose mean 8.8 h; Single-dose range 3.5–18.4 h
LAI available: No

Quick answers

What is temazepam?: Temazepam (brand Restoril) is a benzodiazepine hypnotic indicated for the short-term treatment of insomnia (generally 7 to 10 days on label). It can help with sleep onset and nighttime awakenings, but tolerance, dependence, and next-day impairment make it a poor default long-term strategy.
What is RESTORIL?: RESTORIL is a brand name for temazepam.
What is RESTORIL (temazepam) used for?: Label indications include: Short-term treatment of insomnia (generally 7 to 10 days) (label).
What drug class is RESTORIL (temazepam)?: Benzodiazepine.
What is the mechanism of action of RESTORIL (temazepam)?: Benzodiazepine hypnotic; GABA-A receptor positive allosteric modulator.
What strengths does RESTORIL (temazepam) come in?: Capsules: 7.5 mg, 15 mg, 22.5 mg, 30 mg.

General information

Temazepam is a benzodiazepine hypnotic indicated for the short-term treatment of insomnia (generally 7 to 10 days on label).

It can help with sleep onset and nighttime awakenings, but tolerance, dependence, and next-day impairment make it a poor default long-term strategy; plan a defined endpoint and avoid automatic refills.

Compared with very short-acting hypnotics, temazepam’s longer terminal half-life may reduce late-night rebound but increases morning grogginess and fall risk, especially in older adults and with polypharmacy.

Benzodiazepine harm is driven by total sedative burden: avoid combining with opioids, alcohol, antihistamines, or multiple sedative hypnotics.

The temazepam compare view, temazepam evidence feed, and temazepam print page can support counseling about safe, time-limited hypnotic use.

U.S. approvals

Insomnia (short-term)

Formulations & strengths

Capsules: 7.5 mg, 15 mg, 22.5 mg, 30 mg.

Generic availability

Widely available generically.

Temazepam can be effective for short courses but is not a maintenance plan for chronic insomnia. Use a clear reassessment date, avoid co-prescribing sedatives, and treat underlying causes (mood episodes, substances, pain, sleep apnea). Document indication and duration explicitly to prevent inadvertent long-term use.

View labelExact

Mechanism of action

Refer to the Glossary entry on Neurotransmitters for background on receptor systems involved in serious mental illness.

Positive allosteric modulator of GABA-A receptors, increasing inhibitory neurotransmission and producing anxiolytic and hypnotic effects.

Sedation and cognitive slowing scale with dose and co-administered CNS depressants; “stacking” sedatives is a major driver of harm.

Benzodiazepines can produce tolerance with repeated nightly use, and abrupt discontinuation can trigger rebound insomnia and withdrawal.

GABA-A receptor positive allosteric modulation.

Metabolism & pharmacokinetics

Biphasic elimination: short half-life ~0.4–0.6 hours and terminal half-life 3.5–18.4 hours (mean 8.8 hours) (label).
Minimal first-pass metabolism (~8%); no active metabolites. The major metabolite is an O-conjugate (label).
Longer terminal half-life increases next-day impairment risk compared with very short-acting hypnotics, especially in older adults (label).

Dosing & administration

Usual adult dose: 15 mg at bedtime; some may require 30 mg (label).
Older or debilitated patients: start 7.5 mg to reduce confusion, ataxia, and falls (label).
Confine activities to those needed to prepare for bed after dosing and avoid “middle-of-the-night” redosing.
If use extends beyond a short course, taper gradually rather than stopping abruptly to reduce withdrawal and rebound insomnia.

Monitoring & labs

Reassess insomnia diagnosis and daytime function within 1–2 weeks; discontinue if no meaningful benefit.
Screen for opioid co-prescribing, sleep apnea/COPD, substance use risk, and fall risk before renewing.
Monitor for next-day impairment (driving, falls), confusion, and paradoxical agitation after dose changes.
If used beyond a short course, create and document a gradual taper plan and monitor for withdrawal.

Sources: FDA/DailyMed label; AASM insomnia guideline; benzodiazepine safety guidance.

Adverse effects

FDA boxed warnings

Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death.

Common side effects (≥10%)

Sedation / next-day impairment: Assess driving risk, fall risk, and functional impairment.
Dizziness / ataxia: Higher risk in older adults and with polypharmacy.
Cognitive impairment / anterograde amnesia: Can present as confusion, memory gaps, or disinhibited behavior.
Rebound insomnia: Can occur when stopping after repeated nightly dosing; plan tapers.

Other notable effects

Dependence, tolerance, and withdrawal symptoms with prolonged use; use time-limited courses and taper when discontinuing.
Paradoxical agitation, irritability, or behavioral disinhibition can occur; reassess diagnosis and discontinue if symptoms worsen.
Respiratory depression risk increases with sleep apnea, COPD, alcohol, opioids, and other sedatives.

Interactions

Additive CNS and respiratory depression with opioids, alcohol, and other sedatives.
Temazepam is largely cleared by conjugation rather than CYP metabolism, but interaction risk remains clinically driven by combined sedative load.
Diphenhydramine can potentiate sedation; avoid combining OTC sleep aids with temazepam (label).

Other useful information

Pair hypnotic use with behavioral insomnia treatment (CBT-I, stimulus control, sleep restriction) and treat underlying drivers rather than escalating medication count.
Avoid using temazepam as a nightly long-term plan; use a short trial with a defined stop date and reassess benefit vs harm.
If insomnia persists, consider non-controlled options (ramelteon, low-dose doxepin) or orexin antagonists rather than chronic benzodiazepine therapy.
Only take when a full night in bed is possible (e.g., 7–8 hours) and avoid dosing in the middle of the night; residual sedation is a common reason for falls and driving impairment after hypnotic use.

References

Related hubs:SMI toolkit·Support resources