The safety of insomnia drugs has improved steadily over the past 30 years.
Choosing the right sleep medication is important; some are best at helping people fall asleep, while others help people stay asleep through the night.
Although medications are often recommended for acute insomnia, the first line of treatment for chronic insomnia is behavioral therapy.
Insomniacs know all too well what it’s like to lie awake in a tangle of sheets, the day’s worries parading through the brain as the minutes tick past with agonizing slowness. With studies linking troubled sleep to a variety of health problems including heart attacks and obesity, it’s enough to keep anyone awake at night.
An estimated 30 million Americans wrestle with chronic insomnia. Many suffer in silence. A 2005 National Sleep Foundation survey found that only one-third of patients with insomnia were asked by their primary care physicians about the quality of their sleep. Insomnia sufferers are equally unlikely to raise the issue with their doctors, studies show. And that’s too bad, experts say.
More and safer medications for sleep problems are available. And with a growing list to choose from, doctors can target prescriptions more precisely to specific complaints: trouble falling asleep, for instance, versus trouble staying asleep.
Remedies to help people fall asleep have been around for centuries, from laudanum in the 1800s to barbiturates more recently. “Unfortunately, most of them were addictive and potentially deadly,” said Dr. David Neubauer, associate director of the Sleep Disorders Center at Johns Hopkins University School of Medicine in Baltimore. “The history of sleep medications is really a tale of improving safety.”
A big advance came in the 1970s with the introduction of benzodiazepine drugs like Halcion, Xanax and Restoril. Although far safer than barbiturates, these sleep medications can still cause dependence and withdrawal symptoms like rebound insomnia. That prompted the Food and Drug Administration to approve them only for short-term use, usually no more than two weeks.
The same restrictions remained in place when a new generation of hypnotic drugs, known as nonbenzodiazepines or “Z” drugs, hit the market, starting with Ambien in the early 1990s.
“But it soon became evident that Ambien was really quite different, that it didn’t have the same withdrawal effects or dependency,” said Dr. Michael Thorpy, director of the Sleep-Wake Disorders Center at Montefiore Medical Center in the Bronx.
In one recent study, researchers at Duke University Medical Center pitted Ambien-CR, a controlled-release formulation, against a placebo. After taking the drug for six months, volunteers reported no rebound insomnia when they stopped. Almost 90 percent said the drug helped them sleep, compared with just under 60 percent of the placebo group. Those on the active drug also reported less morning sleepiness and greater ability to concentrate during the day.
Newer nonbenzodiazepines like Lunesta and Sonata have no restrictions on how long they can be used. Even so, they remain on the federal list of controlled substances because of their potential for abuse.
The latest sleeping pill to win F.D.A. approval, called Rozerem, is the first sleeping pill not on that list, because there appears to be little chance it will be abused. The drug, which targets receptors in the brain for the sleep hormone melatonin, represents the first new class of sleep medication in several decades.
Safer sleep medicines are particularly welcome for people whose insomnia is caused by chronic pain or other persistent medical conditions, Dr. Thorpy said. “These are people who are never going to get a good night’s sleep without medication, and who may need hypnotics for the rest of their lives,” he said.
But those people are the exceptions — most insomniacs will not require pills indefinitely. Indeed, medications are generally considered the first-line treatment not for chronic sleep problems but for acute, short-term insomnia brought on by, say, unusual stress at work or the aftermath of surgery.
“Medications can help nip insomnia in the bud, and may prevent it from becoming a chronic problem,” said Wilfred Pigeon, assistant professor of psychiatry at the Sleep and Neurophysiology Research Laboratory at the University of Rochester.
Doctors are increasingly exploiting the differences among nonbenzodiazepines to tailor their prescription to particular sleep complaints.
Chief among these differences is a drug’s half-life, a measure of how long the active ingredients remain in the body, which can range from one to seven hours for the top sleep aids. If the problem is falling asleep, a drug with a short half-life, like Sonata or Rozerem, may be the best choice. If a patient complains about waking in the middle of the night, a medicine with a longer half-life, like Ambien-CR or Lunesta, may work best.
Although the F.D.A. has not yet approved sleeping pills specifically to be taken when people find themselves wide awake in the middle of the night, “many people take Sonata that way, because it has a very short half-life,” Dr. Thorpy said.
A 2006 study by researchers at the Clinilabs Sleep Disorders Institute at St. Luke’s-Roosevelt Hospital Center in New York found that Sonata taken in the middle of the night caused less next-day sleepiness than Ambien, a drug with a longer half-life.
But even the newer sleep medicines have side effects, including reports of people having no memory of raiding the refrigerator or getting behind the wheel the night before. And because sleep medications address only the symptoms of insomnia and not the causes, many experts agree that the best approach when sleep problems persist is cognitive-behavioral therapy, which teaches strategies like better sleep habits and restricting the amount of time spent awake in bed.
“Drugs can help relieve people’s acute anxiety about being able to fall asleep or stay asleep,” Dr. Pigeon said. Behavioral approaches, which in practice are often combined with sleep drugs, “help make lasting changes in the quality of people’s sleep,” he said.
But changing sleep habits takes time, and a shortage of therapists trained in behavioral sleep medicine means that option is not available to everyone who might benefit. Harried physicians often find it easier to write out a prescription than to discuss sleep hygiene with patients, who likewise often seek the quick relief offered by pills.
Small wonder that pharmaceutical researchers are continually in search of novel insomnia drugs. One drug under development, for example, works in a new way to enhance slow-wave sleep, the deepest stage of slumber, with a goal of making people feel more refreshed in the morning.
“People come in complaining about their sleep,” Dr. Neubauer said. “But of course what we’re really looking for is better wakefulness.”