Findings from an insomnia study published on Monday suggest adding placebos into a medication routine or prescribing a lower dose can reduce the amount of sleep drugs needed, without sacrificing a good night’s sleep.
The preliminary study treated 74 adults experiencing chronic insomnia with 10 mg of the sleeping pill zolpidem (Ambien) for four weeks. Then, those responding to zolpidem were then randomly assigned to three dosing groups for 12 weeks: nightly dosing with 10 mg or 5 mg, “intermittent dosing” of 10 mg three to five days a week, or “partial reinforcement” through nightly pills in which half were 10 mg capsules and half were placebo capsules.
All three strategies were equally effective in helping people fall and stay asleep. However, those in the intermittent dosing group reported that they slept worse than the other groups. What this means is people can sleep fine with less medication, although it’s better if they don’t know when they are not getting the sleeping pill.
The study results suggest people can take less sleep medication, which mean lower costs and fewer side effects. Two strategies may work for some patients: add sugar pills, so that people can take fewer doses of medication or use a lower dose. According to researchers, this is the first study that tested a 5 mg dose of zolpidem, as 10 mg is the usual dose.
This supports a FDA decision in 2013 that required that drug makers lower the recommended dose of the sleep medication zolpidem in women. Also, they suggested that men be evaluated for lower doses as well.The FDA said that people may have morning after effects, including problems staying alert while driving.
“To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia,” said Dr. Ellis Unger, M.D a director in the FDA’s Center for Drug Evaluation and Research in a FDA statement. “Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate.”
Chronic insomnia is characterized by difficulty falling asleep or staying asleep at least three nights a week for at least one month. Roughly nine million Americans rely on prescription sleeping pills to treat chronic insomnia. Getting relief with half the drugs shows that maybe less is better, especially because research has found that long-term zolpidem use can cause dependence.
“The clinical effects of sleeping pills cannot be relied on to last forever, and long-term use increases risk of psychological dependence and side effects including daytime drowsiness, nausea, and muscle pain,” said lead author Michael Perlis, PhD, an associate professor in Penn’s department of Psychiatry and director of the Penn Behavioral Sleep Medicine Program in a news statement. “Our research found that changing the industry standard for maintenance therapy can maintain treatment responses and lower the incidence of side effects.”
The study results are published in the journal Sleep Medicine (article is not open access) by researchers from the Perelman School of Medicine at the University of Pennsylvania.
