Ambien CR and Lunesta are the two sleeping medications that have been approved for long term use for insomnia. There are significant side effects that can occur from sleeping pills as well as a failure by some people to follow the directions closely and as a result take the pills at unrecommended times. It is strongly encouraged to only take sleep medication right before going to bed. Some people have reported taking them too early in the evening and have no recollection of being awake and the things they did before going to bed. Also, taking the medication without getting the sufficient amount of sleep can lead to dangerous situations... i.e. getting behind the wheel.
This article from sleepeducation.com gives a strong indication that the side effects aren't something to be swept under the carpet.
FDA Requests Label Change for All Sleep Disorder Drug Products
The U.S. Food and Drug Administration (FDA) has requested that all
manufacturers of sleep disorder drug products strengthen their product
labeling to include stronger language concerning potential risks.
U.S. Food and Drug Administration
FDA News | 03/14/2007
Press Release
The U.S. Food and Drug Administration (FDA) has requested that all
manufacturers of sedative-hypnotic drug products, a class of drugs used
to induce and/or maintain sleep, strengthen their product labeling to
include stronger language concerning potential risks.
These risks include severe allergic reactions and complex
sleep-related behaviors, which may include sleep-driving. Sleep driving
is defined as driving while not fully awake after ingestion of a
sedative-hypnotic product, with no memory of the event.
"There are a number of prescription sleep aids available that
are well-tolerated and effective for many people," said Steven Galson,
M.D., MPH, director of FDA’s Center for Drug Evaluation and Research.
"However, after reviewing the available post-marketing adverse event
information for these products, FDA concluded that labeling changes are
necessary to inform health care providers and consumers about risks."
In December 2006, FDA sent letters to manufacturers of
products approved for the treatment of sleep disorders requesting that
the whole class of drugs revise product labeling to include warnings
about the following potential adverse events:
- Anaphylaxis (severe allergic reaction) and angioedema (severe
facial swelling), which can occur as early as the first time the
product is taken.
- Complex sleep-related behaviors which may include
sleep-driving, making phone calls, and preparing and eating food (while
asleep).
FDA has been working with the product manufacturers over the past
three months to update labeling, notify health care providers and
inform consumers of these risks.
Along with the labeling revisions, FDA has requested that each
product manufacturer send letters to health care providers to notify
them about the new warnings. Manufacturers will begin sending these
letters to providers starting this week.
In addition, FDA has requested that manufacturers of
sedative-hypnotic products develop Patient Medication Guides for the
products to inform consumers about risks and advise them of potential
precautions that can be taken. Patient Medication Guides are handouts
given to patients, families and caregivers when a medicine is
dispensed.
The guides will contain FDA-approved information such as proper use
and the recommendation to avoid ingesting alcohol and/or other central
nervous system depressants. When these Medication Guides are available,
patients being treated with sleep medications should read the
information before taking the product and talk to their doctors if they
have questions or concerns.
Patients should not discontinue the use of these medications without first consulting their health care provider.
Although all sedative-hypnotic products have these risks, there
may be differences among products in how often they occur. For this
reason, FDA has recommended that the drug manufacturers conduct
clinical studies to investigate the frequency with which sleep-driving
and other complex behaviors occur in association with individual drug
products.
The medications that are the focus of the revised labeling include the following 13 products:
- Ambien/Ambien CR (Sanofi Aventis)
- Butisol Sodium (Medpointe Pharm HLC)
- Carbrital (Parke-Davis)
- Dalmane (Valeant Pharm)
- Doral (Questcor Pharms)
- Halcion (Pharmacia & Upjohn)
- Lunesta (Sepracor)
- Placidyl (Abbott)
- Prosom (Abbott)
- Restoril (Tyco Healthcare)
- Rozerem (Takeda)
- Seconal (Lilly)
- Sonata (King Pharmaceuticals)
Consumer Inquiries:
(888) INFO-FDA
Sleep Strategist
