Dalmane

Flurazepam is used to treat insomnia (difficulty falling asleep and staying asleep). Flurazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow sleep.

Flurazepam comes as a capsule to take by mouth. It is usually taken as needed at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take flurazepam exactly as directed.

Flurazepam starts working slowly and continues to work for a short time after you stop taking it. You may experience more benefit from flurazepam on the second and third nights after you start taking it. You may continue to feel the effects of flurazepam for one to two nights after you stop taking the medication.

Your sleep problems should improve within 7 to 10 days after you start taking flurazepam. Call your doctor if your sleep problems do not improve during this time, if they get worse at any time during your treatment, or if you notice any changes in your thoughts or behavior.

Flurazepam can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor.

If your doctor has told you to take flurazepam regularly, talk to your doctor before you stop taking this medication. Your doctor will probably decrease your dose gradually. If you suddenly stop taking flurazepam, especially after taking it regularly, you may develop withdrawal symptoms such as sadness, difficulty sleeping, seizures, uncontrollable shaking of a part of your body, stomach and muscle cramps, vomiting, and sweating.

Flurazepam should only be taken at bedtime. If you forget to take flurazepam at bedtime, you are unable to fall asleep, and you will still be able to stay in bed for a full night's sleep, you may take flurazepam at that time. Do not take a double dose of flurazepam to make up for a missed dose.

Manifestations of Dalmane (flurazepam) overdosage include somnolence, confusion and coma. Respiration, pulse and blood pressure should be monitored as in all cases of drug overdosage. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension and CNS depression may be combated by judicious use of appropriate therapeutic agents. The value of dialysis has not been determined. If excitation occurs in patients following Dalmane (flurazepam) overdosage, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be useful in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, should be consulted prior to use.

Tell your doctor if you are pregnant or plan to become pregnant.

Benzodiazepines may cause fetal damage when administered during pregnancy. Therefore, Dalmane should not be used during pregnancy. Women should be warned of the potential risks to the fetus if they become pregnant while taking Dalmane.

General

• Use hypnotics only when able to get a full night’s sleep before being active again.e

• Use the smallest effective dose (especially in geriatric or debilitated patients and in those with liver disease or low serum albumin).a b d

• Avoid prolonged administration.a d

• Reevaluate patient’s condition if hypnotic use exceeds 2–3 weeks.

• Avoid abrupt discontinuance in patients who have received prolonged therapy (e.g., several months) because of potential for precipitating withdrawal manifestations.a b d Gradually taper dosage.a d

Administration

Oral Administration

Administer at bedtime.a d

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as flurazepam hydrochloride; dosage expressed in terms of the salt.d

Adults

Usual dosage is 30 mg at bedtime.a d In some patients, 15 mg may be adequate.a d

Special Populations

Hepatic Impairment

Reduce dosage.b Use smallest effective dosage.a

Renal Impairment

No specific dosage recommendations.d

Geriatric or Debilitated Patients

Initial dose of 15 mg at bedtime.a d Use smallest effective dosage.a

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take flurazepam just before going to bed, when you are ready to go to sleep.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For insomnia:
    • Adults—
      • Dalmane®: 30 milligrams (mg) at bedtime. Your doctor may adjust your dose if needed.
      • Flurazepam:
        • Men: 15 or 30 mg at bedtime. Your doctor may increase your dose if needed.
        • Women: At first, 15 mg at bedtime.
    • Older adults—15 mg at bedtime. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Data not available

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

UK: Use is not recommended. US: The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

LactMed Record Number

820

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.