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|Dalmane

Dalmane

Dalmane is used for:

Treating sleep disorders. It may also be used for other conditions as determined by your doctor.

Dalmane is a benzodiazepine. It works by depressing the central nervous system (brain), causing drowsiness to aid in falling asleep.

Do NOT use Dalmane if:

• you are allergic to any ingredient in Dalmane
• you have acute narrow-angle glaucoma, severe liver disease, or a mental state in which contact with reality is lost (psychosis)
• you are taking an HIV protease inhibitor (eg, ritonavir) or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dalmane :

Some medical conditions may interact with Dalmane . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have glaucoma or a predisposition for glaucoma, liver problems, lung problems or chronic obstructive pulmonary disease (COPD), muscle problems, depression, suicidal tendencies, the blood disorder known as porphyria, or a history of substance abuse or dependence

Some MEDICINES MAY INTERACT with Dalmane . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Hydantoins (eg, phenytoin) or rifampin because they may decrease Dalmane "s effectiveness
• Aprepitant, clozapine, disulfiram, HIV protease inhibitors (eg, ritonavir), kava, nefazodone, omeprazole, oral contraceptives (birth control pills), sodium oxybate (GHB), or valproic acid because they may increase the risk of Dalmane "s side effects
• Clozapine, digoxin, hydantoins (eg, phenytoin), or nondepolarizing muscle relaxants (eg, vecuronium) because the risk of their side effects may be increased by Dalmane

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dalmane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dalmane :

Use Dalmane as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Dalmane by mouth with or without food.
• Take Dalmane at bedtime with a full glass of water (8 oz/240 mL).
• If you miss a dose of Dalmane , take it when you remember if you are still able to get at least 7 to 8 hours of sleep. If you are no longer able to get at least 7 to 8 hours of sleep when you remember, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dalmane .

Important safety information:

• Dalmane may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Dalmane with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dalmane ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Tell your doctor or dentist that you take Dalmane before you receive any medical or dental care, emergency care, or surgery.
• Use Dalmane with caution in the ELDERLY; they may be more sensitive to its effects, especially daytime drowsiness.
• Dalmane should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• Dalmane should be used with extreme caution in CHILDREN 2 to 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Dalmane if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Dalmane is found in breast milk. Do not breast-feed while taking Dalmane .

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Dalmane . This is known as DEPENDENCE or addiction.

If you stop taking Dalmane suddenly, you may have WITHDRAWAL symptoms. This may include unpleasant feelings. In more severe cases, you may have stomach and muscle cramps, vomiting, sweating, and shakiness. Seizures may rarely occur. If you take Dalmane for more than 1 to 2 weeks, do not stop taking it without talking to your doctor.

Possible side effects of Dalmane :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Clumsiness; dizziness; excessive daytime drowsiness; falling; headache; lightheadedness; staggering; unsteadiness; unusual weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; disorientation; lethargy; severe sedation.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include clumsiness; confusion; deep sleep; loss of consciousness; slow reflexes.

Store Dalmane at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dalmane out of the reach of children and away from pets.

General information:

• If you have any questions about Dalmane , please talk with your doctor, pharmacist, or other health care provider.
• Dalmane is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Dalmane . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.