flur-AZ-e-pam

• Short-term management of insomnia (<4 wk).

• Depresses the CNS, probably by potentiating GABA, an inhibitory neurotransmitter.

• Relief of insomnia.

Absorption: Well absorbed after oral administration.

Distribution: Widely distributed; crosses blood-brain barrier. Probably crosses the placenta and enters breast milk. 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).

Contraindicated in:

• Impaired respiratory function
• Impaired respiratory function
• Sleep apnea
• Hypersensitivity
• Cross-sensitivity with other benzodiazepines may exist
• Pre-existing CNS depression
• Severe uncontrolled pain
• Angle-closure glaucoma
• OB: Chronic use during pregnancy may cause withdrawal effects in neonates
• Lactation: Enters breast milk; discontinue or bottle-feed.

Use Cautiously in:

• Hepatic dysfunction (dose ↓ may be necessary)
• History of suicide attempt or drug dependence
• Debilitated patients (initial dose ↓ may be necessary)
• Pedi: Children <15 yr (safety not established)
• Geri: Appears on Beer's list and is associated with ↑ falls risk in geriatric patients.

Derm: rash.

EENT: blurred vision.

GI: constipation, diarrhea, nausea, vomiting.

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

Misc: physical dependence, psychological dependence, tolerance.

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 ↓ metabolism of flurazepam, enhancing its actions.
• May ↓ efficacy of levodopa.
• Rifampin or barbiturates may ↑ metabolism and decrease ↓ effectiveness of flurazepam.
• Sedative effects may be ↓ by theophylline.

Drug-Natural Products:

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

• PO (Adults): 15–30 mg at bedtime.
• PO (Geriatric Patients or Debilitated Patients): 15 mg initially, may be ↑.

• 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.

Dalmane

Som Pam

Schedule IV (C-IV)

Therapeutic Classification: sedative/hypnotics

Pharmacologic Classification: benzodiazepines

(Generic available)

• Capsules: 15 mg; 30 mg;

(hypnotic activity)

• 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.

• (Indications).
• Sleep deprivation (Indications).
• Risk for falls (Side Effects).

• Advise patient to take medication as directed, do not take more than prescribed or for a longer period than prescribed. Flurazepam taken for a >1 month 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 nictotine 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 female patients 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 (NAAED) Pregnancy Registry by calling 1-888-233-2334; information is available at .

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

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)