flurazepam

Absorption: Well absorbed after oral administration.

Distribution: Widely distributed; crosses blood-brain barrier. Accumulation of drug occurs with chronic dosing.

Protein Binding: 97% (one of the active metabolites).

Metabolism/Excretion: Metabolized by the liver; some metabolites have hypnotic activity.

Half-Life: 2.3 hr (half-life of active metabolite may be 30–200 hr).

Time/Action Profile ⬆ ⬇

(hypnotic activity)

ROUTE	ONSET	PEAK	DURATION
PO	15–45 min	0.5–1 hr	7–8 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Cross-sensitivity with other benzodiazepines may exist;
Impaired respiratory function;
Sleep apnea;
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 dependence;
Pedi: Children 15 yr (safety not established);
Geri: Appears on Beers list and is associated with risk of falls in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

EENT: blurred vision

GI: constipation, diarrhea, nausea, vomiting

Neuro: ↓concentration, ataxia, abnormal thinking, behavior changes, confusion, daytime drowsiness, dizziness, hallucinations, headache, lethargy, mental depression, paradoxical excitation, sleep driving

Misc: physical dependence, psychological dependence, tolerance

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with alcohol, antidepressants, antihistamines, and opioids may result in additive CNS depression.
Cimetidine, hormonal contraceptives, disulfiram, fluoxetine, isoniazid, ketoconazole, metoprolol, propranolol, or valproic acid may ↑ levels and the risk of toxicity.
May ↓ effectiveness of levodopa.
Rifampin, barbiturates, or theophyllinemay ↓ levels and effectiveness.

Drug-Natural Products:

Concomitant use of kava-kava, valerian, chamomile, or hops can ↑ CNS depression.

Route/Dosage ⬆ ⬇

PO (Adults ): 15–30 mg at bedtime, as needed.
PO Geriatric Patients ): 15 mg at bedtime as needed.

Availability ⬆ ⬇

(Generic available)

Capsules: 15 mg; 30 mg

Assessment ⬆ ⬇

Assess sleep patterns before and periodically throughout therapy.
Assess mental status (orientation, mood, behavior) and potential for abuse prior to administering medication.
Prolonged use 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.
Geri: Assess fall risk and institute prevention strategies.
Assess risk for addiction, abuse, or misuse prior to administration and periodically during therapy.

Implementation ⬆ ⬇

Supervise ambulation and transfer of patients after administration. Two side rails should be raised and call bell within reach at all times.
- Gradually taper to discontinue or reduce the dose to reduce risk of withdrawal reactions, increased seizure frequency, and status epilepticus. If withdrawal symptoms develop, pause taper or increase dose to previous tapered dose level; decrease dose more slowly. Some patients may require longer tapering period (weeks to >12 mo).
PO: Capsules may be opened and mixed with food or fluids for patients having difficulty swallowing.

Patient/Family Teaching ⬆ ⬇

Advise patient to take medication as directed; do not take more than prescribed or for a longer period than prescribed. Flurazepam taken for >1 mo should be gradually discontinued to prevent withdrawal symptoms (seizures, psychosis, hallucinations, behavioral disorder, tremor, anxiety).
Advise patient that flurazepam is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children and in a location not accessible by others.
Teach sleep hygiene techniques (dark room, quiet, bedtime ritual, limit daytime napping, avoidance of nicotine and caffeine).
Maximum hypnotic properties are apparent 2–3 nights after initiating therapy and may last 1–2 nights after therapy is discontinued.
Medication may cause daytime drowsiness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
Caution patient to avoid taking alcohol or other CNS depressants, including opioids, concurrently with this medication.
Rep: May cause fetal harm. Advise females of reproductive potential to use a nonhormonal method of contraception during use. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor infants exposed to flurazepam during 2nd and 3rd trimester or immediately prior to or during childbirth for decreased fetal movement and/or fetal heart rate variability, “floppy infant syndrome,” dependence, and symptoms of withdrawal (hypertonia, hyperreflexia, hypoventilation, irritability, tremors, diarrhea, vomiting); may occur shortly after delivery up to 3 wk after birth. Monitor breastfed infants for sedation and poor sucking. Encourage pregnant patients to enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334; information is available at www.aedpregnancyregistry.org.

Evaluation/Desired Outcomes ⬆ ⬇

Improvement in sleep patterns (decreased number of night time awakenings, improved sleep onset, and increased total sleep time).

US Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Code ⬆

NDC Code

0378- Mylan Pharmaceuticals Inc.
- 0378-4415- Flurazepam Hydrochloride
  - 0378-4415-01- 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4415-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-4430- Flurazepam Hydrochloride
  - 0378-4430-01- 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4430-01)

55289- PD-Rx Pharmaceuticals, Inc.
- 55289-038- Flurazepam Hydrochloride
  - 55289-038-30- 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-038-30)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇