quazepam

BEERS REMS

Short-term (up to 4 wk) management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early-morning awakenings.

Action ⬆ ⬇

Depresses the CNS, probably by potentiating gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter.

Therapeutic effects:

Relief of insomnia.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed after oral administration.

Distribution: Unknown.

Protein Binding: >95%.

Metabolism/Excretion: Mostly metabolized by the liver. Two metabolites have CNS depressant activity (2-oxoquazepam and N-desalkylflurazepam).

Half-Life: Quazepam: 39 hr (↑ in older adults); 2-oxoquazepam: 39 hr; N-desalkylflurazepam: 70–75 hr.

Time/Action Profile ⬆ ⬇

(sedation)

ROUTE	ONSET	PEAK	DURATION
PO	30 min	2 hr	8 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Cross-sensitivity with other benzodiazepines may exist;
Pre-existing CNS depression;
Severe uncontrolled pain;
Angle-closure glaucoma;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Hepatic impairment (↓ dose may be necessary);
History of suicide attempt or drug abuse;
Pedi: Safety and effectiveness not established in children;
Geri: Appears on Beers list and is associated with risk of falls in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: palpitations

Derm: itching, rash

EENT: blurred vision

GI: abdominal pain, constipation, diarrhea, dry mouth, nausea, vomiting

GU: changes in libido, urinary frequency, urinary hesitancy

MS: muscle spasm

Neuro: daytime drowsiness, abnormal thinking, ataxia, behavior changes, confusion, dizziness, hallucinations, headache, insomnia, nervousness, sleep driving, slurred speech, trembling, weakness

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), physical dependence, psychological dependence, tolerance

Interactions ⬆ ⬇

Drug-drug:

Additive CNS depression with alcohol, antihistamines, antidepressants, MAO inhibitors, other sedative/hypnotics, or opioid analgesics.
Cimetidine or hormonal contraceptives may ↑ levels and risk of toxicity.
May ↓ efficacy of levodopa.
Rifampin or cigarette smoking (nicotine) may ↓ levels and effectiveness.

Drug-Natural Products:

St. John's wort may ↓ levels and effectiveness.
Concomitant use of kava, valerian, chamomile, or hops can ↑ CNS depression.

Route/Dosage ⬆ ⬇

PO (Adults ): 7.5 mg at bedtime; may be ↑ to 15 mg at bedtime if needed.

Availability ⬆ ⬇

Assessment ⬆ ⬇

Assess sleep patterns before and periodically throughout therapy.
Geri: Assess risk of falls and institute fall prevention strategies..
Prolonged therapy may lead to psychological or physical dependence. Restrict amount of drug available to patient, especially if patient is depressed, suicidal, or has a history of substance use disorder.

Implementation ⬆ ⬇

Supervise ambulation and transfer of patients after administration. Side rails should be raised and call bell within reach at all times.
PO: Split 15 mg tablet on scored line to get 7.5 mg dose.

Patient/Family Teaching ⬆ ⬇

Advise patient to take medication exactly as directed. Discuss the importance of preparing environment for sleep (dark room, quiet, avoidance of nicotine and caffeine). Gradual discontinuation may be required after prolonged therapy. May cause disturbed sleep for the first 2 nights after discontinuation of quazepam.
Medication may cause daytime drowsiness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known. Geri: Instruct patient and family how to reduce falls risk at home.
Caution patient that complex sleep-related behaviors (sleep driving) may occur while asleep.
Caution patients to avoid taking alcohol or other CNS depressants concurrently with this medication.
Advise patient to notify health care professional immediately if signs of anaphylaxis (swelling of the tongue or throat, trouble breathing, and nausea and vomiting) occur.
Rep: Instruct females of reproductive potential to contact health care professional immediately if pregnancy is planned or suspected and to avoid breastfeeding during therapy.

Evaluation/Desired Outcomes ⬆ ⬇

Improvement in sleep pattern.
Improved ability to fall asleep.
Improved ability to stay asleep during night.
Decreased early-morning awakenings.
- Continued insomnia after 7–10 days of therapy may indicate need for evaluation for primary psychiatric and/or medical illness.

US Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Code ⬆

NDC Code

61825- Galt Pharmaceuticals, LLC
- 61825-165- DORAL
  - 61825-165-10- 100 TABLET in 1 BOTTLE (61825-165-10)

61825- Galt Pharmaceuticals, LLC
- 61825-165- DORAL
  - 61825-165-30- 30 TABLET in 1 BOTTLE (61825-165-30)

71993- Atland Pharmaceuticals, LLC
- 71993-265- Quazepam
  - 71993-265-10- 100 TABLET in 1 BOTTLE (71993-265-10)

71993- Atland Pharmaceuticals, LLC
- 71993-265- Quazepam
  - 71993-265-30- 30 TABLET in 1 BOTTLE (71993-265-30)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇