Insomniacs should be given placebos mixed with real pills – new study

© Darren Staples
US scientists say they have developed a novel therapy for long-term insomniacs which does not leave them taking ineffective drugs and suffering from intermittent sleepless nights. However, questions remain as to whether it is ethical.

Pills against insomnia often lose their effectiveness 12 months after being taken nightly, in addition to carrying significant side effects even when they work, such as drowsiness, headache and confusion.

“If these medications do not cure, which they don't, how do you treat patients with chronic insomnia for years or decades?” asked Michael Perlis of the University of Pennsylvania, the lead author of a study that has just been published in the journal Sleep Medicine.

The traditional answer has been slowly reducing the dosage, and making patients take the drugs three to five times a week – on alternate nights, or when they struggle to sleep.

"The intermittent dosing schedule may be a good way to be conservative about drugs, but half the week will be lousy and the other half the week is OK. Ultimately, your insomnia is going to get worse," Perlis told the Philadelphia Inquirer.

Perlis decided on a better solution: A placebo.

For three weeks, his team divided 55 adult insomniacs into three camps: one given a 10 or 5mg mg pill of zolpidem – the chemical name for Ambien – every night, another treated with three to five 10 mg pills every week, and the third group given 10 mg pills, only half of which were real, and ordered to take one every night.

After 12 weeks, results were compared.

"When it comes to day-to-day quality of therapeutic outcomes, the strategy we use most frequently, the intermittent doing strategy performed worst," Perlis said. The daily dosed subjects and those taking the placebo fared similarly well.

Perlis noted that it was not just knowledge that the patient would be taking a pill that helped the placebo group relax, but the routine of seeing and swallowing it.

"This effect is thought to occur owing not only to the enhancement of patient expectancy but to the conditioning of medication effects, i.e., the medication induced effects may be elicited, with conditioning, by the medication capsule itself and that this can be sustained over time with occasional use of full dose medication as reinforcement."

Ethical issues remain: would potential patients be informed that they are taking a placebo, and how would that affect the effectiveness of the treatment and the trust between doctor and patient? What if a patient, told he was prescribed a mixed batch, thought he had ingested a placebo, and then went on to take another efficacious pill, and suffered an overdose?

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But the scientific community has broadly welcomed the research, noting that placebos were always likely to be effective in a problem that is largely self-induced by the insomniacs’ anxiety.

"We know that there is a very strong placebo response in insomnia. So taking something every night is a good idea, even if it's a placebo," Karl Doghramji, director of the Sleep Disorders Center at Thomas Jefferson University Hospital, told the Philadelphia Inquirer, urging Penn scientists to conduct studies on a bigger test group.

The effects of placebos are thought to have been known since ancient times, understandably, considering the limits of medications available to ancient Greeks, or medieval healers.

A landmark 2013 British survey of doctors, showed that 97 percent still prescribe placebos, most of them on a weekly basis. While a minority give out sugar pills, most use real medicines, given to patients for incorrect conditions, to induce a psychological recovery, fob off hypochondriacs, and help those whose illnesses remain impossible to diagnose. Nearly nine out ten doctors said they did not tell their patients they were giving them a placebo.

While the practice is not illegal, it happens without supervision, and it remains unclear if such grey practices can be used officially to help America’s 9 million sleeping pill users.