Somnote

Chloral hydrate is a sedative, also called a hypnotic. Chloral hydrate slows the activity of your central nervous system. This medicine has both fast-acting and long-lasting sedative effects.

Chloral hydrate is for short-term use as a sedative or sleep medicine. It is sometimes given before a surgery to help you relax.

Chloral hydrate may also be used to treat alcohol withdrawal symptoms, or to relieve anxiety caused by withdrawal from certain drugs such as barbiturates or narcotic medicine.

Chloral hydrate may also be used for purposes not listed in this medication guide.

You should not use chloral hydrate if you have severe kidney or liver disease.

You should not use chloral hydrate if you are allergic to it, or if you have:

• severe kidney disease; or
• severe liver disease.

To make sure chloral hydrate is safe for you, tell your doctor if you have:

• a history of liver or kidney disease;
• stomach ulcer, or problems with your esophagus;
• a stomach disorder such as gastroesophageal reflux disease (GERD);
• heart disease;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• depression, or a history of suicidal thoughts or actions;
• history of drug addiction; or
• if you take furosemide (Lasix), or a blood thinner (warfarin, Coumadin, Jantoven).

FDA pregnancy category C. It is not known whether chloral hydrate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Chloral hydrate can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

Older adults may be more sensitive to the effects of this medication.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with chloral hydrate.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking chloral hydrate with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with chloral hydrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may be habit-forming with long-term use.
• When sleep drugs are used nightly for more than a few weeks, they may not work as well to help sleep problems. This is known as tolerance. Only use sleep drugs for a short time. If sleep problems last, call the doctor.
• If you have been taking Somnote on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this medicine all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• Avoid driving and doing other tasks or actions that call for you to be alert after you take Somnote. You may still feel sleepy the day after you take this medicine. Avoid these tasks or actions until you feel fully awake.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Avoid alcohol while taking Somnote. Do not take this medicine if you drank alcohol that evening or before bed.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Somnote.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
• If you are 65 or older, use Somnote with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad belly pain.
• Change in balance.
• Feeling confused.
• Change in how you act.
• Hallucinations (seeing or hearing things that are not there).
• Fever or chills.
• Sore throat.
• Very bad dizziness or passing out.
• A heartbeat that does not feel normal.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
• Some people have done certain tasks or actions while they were not fully awake like driving, making and eating food, and having sex. Most of the time, people do not remember doing these things. Tell your doctor if this happens to you.

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Chloral Hydrate is the oldest member of the hypnotic group of drugs. The action of Chloral Hydrate is confined to the cerebral hemispheres. Chloral Hydrate is detoxified in the liver and subsequently eliminated by the kidney.

Chloral Hydrate is used primarily as a hypnotic in the management of simple insomnia. It is effective as a hypnotic only for short term use. Chloral Hydrate has been found to lose much of its effectiveness for both inducing and maintaining sleep by the end of a 2 week period of administration. Chloral Hydrate may also be used as a routine sedative. It has been used preoperatively or prior to electroencephalographic evaluation to allay anxiety and produce sedation and/or sleep. Chloral Hydrate, alone or in conjunction with Paraldehyde, may be effective in suppressing and/or reducing alcohol withdrawal symptoms. It may also be effective in reducing anxiety associated with withdrawal of other drugs such as narcotics or barbiturates.

Somnote® Capsules are supplied as gray, oval-shaped softgel capsules, imprinted "B-080". Available in unit dose packaging 50 capsules (5 × 10), NDC 51991-080-51, and bottles containing 50 capsules, NDC 51991-080-52.

Store at 25°C (77°F); excursions permitted to 15°-30°C(59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Manufactured by:
G. Pohl Boskamp GmbH & Co.
Hohenlockstedt, Germany

Distributed By:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

REV. 5/09
Rx Only

Breckenridge
Pharmaceutical, Inc.

NDC 51991-080-52

Somnote®
(Chloral Hydrate Capsules, USP)

500 mg

Rx Only

50 Capsules

New
Appearance

Applies to chloral hydrate: oral capsules, oral solution, rectal suppositories

Side effects include:

Nausea, vomiting, diarrhea, ataxia, dizziness.