Natrol (SAMe)

Natrol (also known as SAMe) is a synthetic version of a chemical that is naturally found in the body.

SAMe is likely effective in alternative medicine as a help for osteoarthritis.

SAMe has been used in alternative medicine as a possibly effective treatment for itching, tiredness, and unusual lab results in people with liver disease, and for improving symptoms in people with depression.

Other uses that have not been proven by research include treating alcohol-related liver disease, schizophrenia, aging, Alzheimer disease, fibromyalgia, chronic back pain, migraine headaches, seizures, premenstrual syndrome, and chronic fatigue syndrome.

It is not clear if SAMe is effective for treating any medical condition. The FDA has not approved its medicinal use. SAMe should not replace any medication prescribed by your doctor.

SAMe is often sold as an herbal supplement. Many herbal products do not have regulated manufacturing standards, and some supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be bought from a trustworthy source to reduce the risk of contamination.

SAMe may also be used for reasons not listed in this product guide.

When thinking about using SAMe, talk to your doctor. You might also want to consult a practitioner who is trained in herbal or health supplements.

If you decide to use SAMe, take it as directed on the package or as instructed by your doctor, pharmacist, or other healthcare provider. Do not take more of this product than what is recommended on the label.

SAMe should be taken on an empty stomach, at least 30 to 60 minutes before a meal or two hours after a meal.

Call your doctor if your symptoms do not improve, or if they get worse.

If you need surgery, stop taking SAMe at least 2 weeks before the procedure.

Store at room temperature, away from moisture and heat.

You should not use SAMe if you have bipolar depression, anxiety disorder, or if you take medicine for depression.

Do not use SAMe if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use SAMe if you have bipolar disorder (manic depression), anxiety disorder, or if you take antidepressant medications.

Do not use SAMe if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you are also using stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with SAMe could cause a serious condition called serotonin syndrome.

Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have:

• a planned surgery;
• Lesch-Nyhan syndrome; or
• Parkinson's disease.

It is not known whether SAMe will harm an unborn baby. Do not use this product without medical advice if you are pregnant.

SAMe is considered likely unsafe to use if you are nursing a baby. Do not use this product without medical advice if you are breastfeeding a baby.

Do not give any herbal/health supplement to a child without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Although not all side effects are known, SAMe is thought to be likely safe for most adults when used as directed.

Common side effects of Natrol may include:

• changes in hair color;
• headache, dizziness;
• feeling anxious or nervous;
• loss of appetite, vomiting, nausea, upset stomach;
• dry mouth;
• diarrhea, constipation;
• increased sweating; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you miss a dose, skip it and take your next dose at the usual time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your healthcare provider's instructions regarding any restrictions on food, drinks, or activities.

Do not take SAMe without medical advice if you are using any of the following medications:

• dextromethorphan (a cough medicine such as Robitussin DM);
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines;
• levodopa; or
• a narcotic medicine such as meperidine (Demerol), pentazocine, or tramadol (Ultram, Ultracet).

This list is not complete. Other drugs may affect SAMe, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.