quazepam
Last reviewed 2025-12-30
Reviewed by PsychMed Editorial Team.
Brands: DORAL
Sources updated 2025 • 5 references
General Information
Quazepam is a benzodiazepine hypnotic indicated for insomnia characterized by difficulty falling asleep, frequent awakenings, and/or early morning awakenings (label). It is generally used as a short course rather than a chronic nightly medication.
Quazepam’s long duration is driven by active metabolites with long half-lives. Accumulation over 1–2 weeks can produce increasing morning impairment, falls, and impaired driving risk even if the nightly dose is unchanged (label).
Benzodiazepine risks include abuse/misuse, addiction, and clinically significant physical dependence with withdrawal reactions; these risks support a defined duration with follow-up and an exit/taper plan (label / safety guidance).
Boxed warning: Concomitant use with opioids can cause profound sedation, respiratory depression, coma, and death; avoid co-prescribing when possible (label).
The quazepam compare view, quazepam evidence feed, and quazepam print page can support shared decision-making, including taper planning and impairment counseling.
U.S. approvals
- Insomnia ()
Formulations & strengths
- Functionally scored tablets: 15 mg (split to 7.5 mg).
Generic availability
- Widely available generically.
Quazepam is often positioned as a longer-duration benzodiazepine hypnotic. Because its metabolites accumulate, teams commonly emphasize a short course, cautious dosing, and monitoring for morning impairment and falls, especially in older adults.
View labelExactMechanism 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, producing hypnotic effects via increased inhibitory neurotransmission.
Sedation and cognitive slowing scale with dose and co-administered CNS depressants; total sedative burden drives harm.
Repeated nightly use can produce tolerance and dependence; abrupt discontinuation can trigger withdrawal symptoms and rebound insomnia.
- GABA-A receptor positive allosteric modulation.
Metabolism and Pharmacokinetics
- Rapidly absorbed; peak plasma concentration occurs at about 2 hours after a 15 mg dose (label).
- Mean elimination half-life is 39 hours for quazepam/2-oxoquazepam and 73 hours for N-desalkyl-2-oxoquazepam (label).
- Steady-state levels are attained by ~day 7 for quazepam/2-oxoquazepam and ~day 13 for N-desalkyl-2-oxoquazepam; accumulation increases carryover impairment risk (label).
- In geriatric patients, the elimination half-life of the desalkyl metabolite may be about twice that of younger adults (label).
Dosing and Administration
- Recommended initial dose is 7.5 mg at bedtime; increase to 15 mg if needed for efficacy (label).
- The 7.5 mg dose is achieved by splitting the 15 mg tablet along the score line (label).
- Use the lowest effective dose; prolonged administration is generally not necessary or recommended, and persistent insomnia should prompt reassessment for a more specific treatment target (label).
- If used beyond a short course, tapering is commonly used to reduce withdrawal symptoms and rebound insomnia (label).
Monitoring & Labs
- Reassess within 1–2 weeks for next-day impairment, falls, driving safety, and cognitive changes as metabolites accumulate.
- Screen for opioid co-prescribing, alcohol use, substance use risk, and sleep apnea before renewing.
- Review concurrent CNS depressants and counsel against alcohol co-use.
- If use extends beyond a brief course, document a taper plan and monitor for withdrawal symptoms.
Sources: FDA/DailyMed label; insomnia guideline context; 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: Carryover effects can increase over 1–2 weeks as metabolites reach steady state; assess driving and falls.
- Dizziness / ataxia: Contributes to falls; higher risk in older adults and polypharmacy.
- Confusion / over-sedation: Particularly important in older adults; reassess if delirium-like symptoms occur.
- Rebound insomnia: Can occur with discontinuation after repeated use; tapering reduces risk.
Other notable effects
- Dependence and withdrawal reactions (including seizures in severe cases) can occur after prolonged use; avoid abrupt discontinuation.
- Respiratory depression risk increases with alcohol, opioids, untreated sleep apnea/COPD, and other sedatives.
- Abuse/misuse and addiction risk increases with co-use of alcohol or other substances (label).
Interactions
- Additive CNS depression occurs with ethanol and other CNS depressants; dose adjustment may be needed when combinations are unavoidable (label).
- Long duration means interaction effects can persist for days; review new sedatives and opioid dose changes carefully.
- Avoid combining multiple hypnotics except in exceptional, closely monitored situations.
Other Useful Information
- Insomnia is often transient and may be a symptom of another disorder; when insomnia persists, treating the driver (mood episode, pain, substance use, sleep apnea) usually improves outcomes more than escalating hypnotics.
- For chronic insomnia, guidelines often prioritize CBT-I and non-benzodiazepine options rather than chronic benzodiazepine use.
- Documenting the planned duration and taper strategy helps prevent inadvertent long-term use and withdrawal risk.
References
- Quazepam tablets prescribing information — DailyMed (2025)
- Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline — Journal of Clinical Sleep Medicine (2017)
- ASAM guideline on benzodiazepines — Journal of Addiction Medicine (2020)
- Efficacy and Acceptability of Pharmacological Interventions for Insomnia in Patients With Severe Mental Illness — Acta Psychiatrica Scandinavica (2025)
- Residual effects of medications for sleep disorders on driving performance — European Neuropsychopharmacology (2024)
